Trial Outcomes & Findings for Tele-Exercise and Multiple Sclerosis (NCT NCT03117881)
NCT ID: NCT03117881
Last Updated: 2024-12-11
Results Overview
Pain was measured by 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100, with a higher score indicating less pain. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for rDirectCAM reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
911 participants
Primary outcome timeframe
48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.
Results posted on
2024-12-11
Participant Flow
Participant milestones
| Measure |
DirectCAM
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Baseline
STARTED
|
425
|
412
|
74
|
|
Baseline
COMPLETED
|
382
|
377
|
74
|
|
Baseline
NOT COMPLETED
|
43
|
35
|
0
|
|
Post-Intervention Follow-Up (3 Months)
STARTED
|
382
|
377
|
74
|
|
Post-Intervention Follow-Up (3 Months)
COMPLETED
|
289
|
296
|
67
|
|
Post-Intervention Follow-Up (3 Months)
NOT COMPLETED
|
93
|
81
|
7
|
|
6-Month Follow-Up
STARTED
|
344
|
318
|
69
|
|
6-Month Follow-Up
COMPLETED
|
269
|
277
|
60
|
|
6-Month Follow-Up
NOT COMPLETED
|
75
|
41
|
9
|
|
12-Month Follow-Up
STARTED
|
322
|
302
|
0
|
|
12-Month Follow-Up
COMPLETED
|
261
|
278
|
0
|
|
12-Month Follow-Up
NOT COMPLETED
|
61
|
24
|
0
|
Reasons for withdrawal
| Measure |
DirectCAM
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Baseline
Withdrawal by Subject
|
21
|
10
|
0
|
|
Baseline
Lost to Follow-up
|
22
|
25
|
0
|
|
Post-Intervention Follow-Up (3 Months)
Withdrawal by Subject
|
26
|
21
|
1
|
|
Post-Intervention Follow-Up (3 Months)
Lost to Follow-up
|
34
|
38
|
4
|
|
Post-Intervention Follow-Up (3 Months)
Did not complete test
|
33
|
22
|
2
|
|
6-Month Follow-Up
Withdrawal by Subject
|
4
|
8
|
0
|
|
6-Month Follow-Up
Lost to Follow-up
|
18
|
8
|
2
|
|
6-Month Follow-Up
Did not complete test
|
53
|
25
|
7
|
|
12-Month Follow-Up
Withdrawal by Subject
|
3
|
2
|
0
|
|
12-Month Follow-Up
Lost to Follow-up
|
18
|
22
|
0
|
|
12-Month Follow-Up
Did not complete test
|
40
|
0
|
0
|
Baseline Characteristics
The number is less than the total because of missing values in the data.
Baseline characteristics by cohort
| Measure |
DirectCAM
n=382 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=377 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=74 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
Total
n=833 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 10.3 • n=382 Participants
|
50.0 years
STANDARD_DEVIATION 11.0 • n=377 Participants
|
49.3 years
STANDARD_DEVIATION 11.7 • n=74 Participants
|
50.1 years
STANDARD_DEVIATION 10.8 • n=833 Participants
|
|
Sex: Female, Male
Female
|
341 Participants
n=382 Participants
|
335 Participants
n=377 Participants
|
62 Participants
n=74 Participants
|
738 Participants
n=833 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=382 Participants
|
42 Participants
n=377 Participants
|
12 Participants
n=74 Participants
|
95 Participants
n=833 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=382 Participants
|
1 Participants
n=377 Participants
|
0 Participants
n=74 Participants
|
2 Participants
n=833 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=382 Participants
|
0 Participants
n=377 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=833 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=382 Participants
|
0 Participants
n=377 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=833 Participants
|
|
Race (NIH/OMB)
Black or African American
|
94 Participants
n=382 Participants
|
86 Participants
n=377 Participants
|
20 Participants
n=74 Participants
|
200 Participants
n=833 Participants
|
|
Race (NIH/OMB)
White
|
278 Participants
n=382 Participants
|
278 Participants
n=377 Participants
|
53 Participants
n=74 Participants
|
609 Participants
n=833 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=382 Participants
|
6 Participants
n=377 Participants
|
0 Participants
n=74 Participants
|
7 Participants
n=833 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=382 Participants
|
6 Participants
n=377 Participants
|
1 Participants
n=74 Participants
|
14 Participants
n=833 Participants
|
|
Region of Enrollment
United States
|
382 participants
n=382 Participants
|
377 participants
n=377 Participants
|
74 participants
n=74 Participants
|
833 participants
n=833 Participants
|
|
Pain measured by 36-Item Short Form Survey (SF-36) Pain domain
|
56.84 units on a scale
STANDARD_DEVIATION 23.88 • n=382 Participants • The number is less than the total because of missing values in the data.
|
58.64 units on a scale
STANDARD_DEVIATION 24.62 • n=377 Participants • The number is less than the total because of missing values in the data.
|
60.70 units on a scale
STANDARD_DEVIATION 25.85 • n=68 Participants • The number is less than the total because of missing values in the data.
|
57.98 units on a scale
STANDARD_DEVIATION 24.38 • n=827 Participants • The number is less than the total because of missing values in the data.
|
|
Fatigue measured by Modified Fatigue impact Scale
|
43.64 units on a scale
STANDARD_DEVIATION 16.80 • n=375 Participants • The number is less than the total because of missing values in the data.
|
42.84 units on a scale
STANDARD_DEVIATION 16.98 • n=368 Participants • The number is less than the total because of missing values in the data.
|
40.19 units on a scale
STANDARD_DEVIATION 19.50 • n=68 Participants • The number is less than the total because of missing values in the data.
|
42.99 units on a scale
STANDARD_DEVIATION 17.12 • n=811 Participants • The number is less than the total because of missing values in the data.
|
|
Quality of life measured by 36-Item Short Form Survey (SF-36) physical component score
|
35.03 units on a scale
STANDARD_DEVIATION 11.30 • n=355 Participants • The number is less than the total because of missing values in the data.
|
35.80 units on a scale
STANDARD_DEVIATION 11.21 • n=350 Participants • The number is less than the total because of missing values in the data.
|
39.30 units on a scale
STANDARD_DEVIATION 11.43 • n=68 Participants • The number is less than the total because of missing values in the data.
|
35.75 units on a scale
STANDARD_DEVIATION 11.32 • n=773 Participants • The number is less than the total because of missing values in the data.
|
|
Quality of life measured by 36-Item Short Form Survey (SF-36) mental component score
|
42.77 units on a scale
STANDARD_DEVIATION 14.78 • n=355 Participants • The number is less than the total because of missing values in the data.
|
43.05 units on a scale
STANDARD_DEVIATION 14.67 • n=350 Participants • The number is less than the total because of missing values in the data.
|
41.71 units on a scale
STANDARD_DEVIATION 14.94 • n=68 Participants • The number is less than the total because of missing values in the data.
|
42.80 units on a scale
STANDARD_DEVIATION 14.73 • n=773 Participants • The number is less than the total because of missing values in the data.
|
|
Physical activity measured by Godin Leisure Time Exercise Score
|
14.16 units on a scale
STANDARD_DEVIATION 16.56 • n=319 Participants • The number is less than the total because of missing values in the data.
|
17.72 units on a scale
STANDARD_DEVIATION 55.70 • n=330 Participants • The number is less than the total because of missing values in the data.
|
3.16 units on a scale
STANDARD_DEVIATION 3.73 • n=68 Participants • The number is less than the total because of missing values in the data.
|
14.75 units on a scale
STANDARD_DEVIATION 39.57 • n=717 Participants • The number is less than the total because of missing values in the data.
|
|
Balance measured by Berg Balance Scale
|
44.16 units on a scale
STANDARD_DEVIATION 14.27 • n=382 Participants • The number is less than the total because of missing values in the data.
|
47.37 units on a scale
STANDARD_DEVIATION 12.18 • n=375 Participants • The number is less than the total because of missing values in the data.
|
52.07 units on a scale
STANDARD_DEVIATION 7.26 • n=44 Participants • The number is less than the total because of missing values in the data.
|
46.10 units on a scale
STANDARD_DEVIATION 13.18 • n=801 Participants • The number is less than the total because of missing values in the data.
|
|
Balance measured by Five Times Sit to Stand
|
19.55 seconds
STANDARD_DEVIATION 12.48 • n=363 Participants • The number is less than the total because of missing values in the data.
|
17.88 seconds
STANDARD_DEVIATION 9.25 • n=367 Participants • The number is less than the total because of missing values in the data.
|
15.79 seconds
STANDARD_DEVIATION 6.68 • n=48 Participants • The number is less than the total because of missing values in the data.
|
18.53 seconds
STANDARD_DEVIATION 10.80 • n=778 Participants • The number is less than the total because of missing values in the data.
|
|
Endurance measured by Six Minute Walk Test
|
296.98 meters
STANDARD_DEVIATION 127.19 • n=358 Participants • The number is less than the total because of missing values in the data.
|
317.74 meters
STANDARD_DEVIATION 124.48 • n=359 Participants • The number is less than the total because of missing values in the data.
|
—
|
307.38 meters
STANDARD_DEVIATION 126.18 • n=717 Participants • The number is less than the total because of missing values in the data.
|
|
Gait measured by Timed Up and Go
|
16.89 seconds
STANDARD_DEVIATION 25.06 • n=371 Participants • The number is less than the total because of missing values in the data.
|
14.50 seconds
STANDARD_DEVIATION 21.05 • n=370 Participants • The number is less than the total because of missing values in the data.
|
9.82 seconds
STANDARD_DEVIATION 5.52 • n=44 Participants • The number is less than the total because of missing values in the data.
|
15.37 seconds
STANDARD_DEVIATION 22.58 • n=785 Participants • The number is less than the total because of missing values in the data.
|
|
Gait measured by Timed 25-Foot Walk Test
|
11.72 seconds
STANDARD_DEVIATION 27.53 • n=366 Participants • The number is less than the total because of missing values in the data.
|
8.38 seconds
STANDARD_DEVIATION 9.62 • n=363 Participants • The number is less than the total because of missing values in the data.
|
—
|
10.06 seconds
STANDARD_DEVIATION 20.70 • n=729 Participants • The number is less than the total because of missing values in the data.
|
|
Grip strength measured by hand dynamometer
|
50.86 pounds
STANDARD_DEVIATION 20.58 • n=377 Participants • The number is less than the total because of missing values in the data.
|
51.41 pounds
STANDARD_DEVIATION 19.45 • n=365 Participants • The number is less than the total because of missing values in the data.
|
49.13 pounds
STANDARD_DEVIATION 19.97 • n=49 Participants • The number is less than the total because of missing values in the data.
|
51.01 pounds
STANDARD_DEVIATION 20.01 • n=791 Participants • The number is less than the total because of missing values in the data.
|
|
Outcome Expectations for Exercise measured by Multidimensional Outcome Expectations for Exercise
|
60.16 units on a scale
STANDARD_DEVIATION 7.39 • n=376 Participants • The number is less than the total because of missing values in the data.
|
60.51 units on a scale
STANDARD_DEVIATION 7.54 • n=377 Participants • The number is less than the total because of missing values in the data.
|
59.22 units on a scale
STANDARD_DEVIATION 6.48 • n=68 Participants • The number is less than the total because of missing values in the data.
|
60.25 units on a scale
STANDARD_DEVIATION 7.39 • n=821 Participants • The number is less than the total because of missing values in the data.
|
|
Exercise Self Efficacy measured by Exercise Self-Efficacy Scale
|
80.90 units on a scale
STANDARD_DEVIATION 16.71 • n=377 Participants • The number is less than the total because of missing values in the data.
|
91.14 units on a scale
STANDARD_DEVIATION 14.27 • n=376 Participants • The number is less than the total because of missing values in the data.
|
87.56 units on a scale
STANDARD_DEVIATION 18.08 • n=68 Participants • The number is less than the total because of missing values in the data.
|
90.28 units on a scale
STANDARD_DEVIATION 15.78 • n=821 Participants • The number is less than the total because of missing values in the data.
|
|
Social Support for Exercise measured by Social Provisions Scale
|
12.39 units on a scale
STANDARD_DEVIATION 2.12 • n=377 Participants • The number is less than the total because of missing values in the data.
|
12.27 units on a scale
STANDARD_DEVIATION 2.06 • n=374 Participants • The number is less than the total because of missing values in the data.
|
15.65 units on a scale
STANDARD_DEVIATION 1.93 • n=68 Participants • The number is less than the total because of missing values in the data.
|
12.61 units on a scale
STANDARD_DEVIATION 2.27 • n=819 Participants • The number is less than the total because of missing values in the data.
|
|
Exercise Self Regulation measured by Exercise Goal-Setting Scale
|
23.28 units on a scale
STANDARD_DEVIATION 10.06 • n=380 Participants • The number is less than the total because of missing values in the data.
|
23.47 units on a scale
STANDARD_DEVIATION 9.45 • n=362 Participants • The number is less than the total because of missing values in the data.
|
20.29 units on a scale
STANDARD_DEVIATION 9.44 • n=68 Participants • The number is less than the total because of missing values in the data.
|
23.12 units on a scale
STANDARD_DEVIATION 9.76 • n=810 Participants • The number is less than the total because of missing values in the data.
|
PRIMARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Pain was measured by 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100, with a higher score indicating less pain. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for rDirectCAM reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=382 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=377 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=68 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Pain
|
1.64 score on a scale
Interval -0.6 to 3.88
|
1.53 score on a scale
Interval -0.72 to 3.78
|
-2.12 score on a scale
Interval -7.4 to 3.15
|
PRIMARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Fatigue was measured by Modified Fatigue Impact Scale (MFIS). The total score range is 0 to 84, with a higher score indicating more fatigue. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=375 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=368 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=68 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Fatigue
|
-2.57 score on a scale
Interval -3.9 to -1.24
|
-3.58 score on a scale
Interval -4.92 to -2.23
|
-1.36 score on a scale
Interval -4.49 to 1.77
|
PRIMARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.The physical component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Physical Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the physical component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=355 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=350 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=68 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Quality of Life (Physical Component)
|
1.34 score on a scale
Interval 0.36 to 2.86
|
1.86 score on a scale
Interval 0.91 to 2.86
|
0.70 score on a scale
Interval -1.44 to 2.83
|
PRIMARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.The mental component of quality of life was measured by the 36-Item Short Form Survey (SF-36) Mental Component score. The score ranges from 0 to 100, with higher scores indicating better quality of life in the mental component. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=355 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=350 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=68 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Quality of Life (Mental Component)
|
0.42 score on a scale
Interval -1.06 to 1.9
|
1.10 score on a scale
Interval -0.38 to 2.57
|
-1.09 score on a scale
Interval -4.38 to 2.19
|
PRIMARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ). The score ranges from 0 to 119, with higher scores indicating more physical activity. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=319 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=330 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=68 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Physical Activity
|
3.74 score on a scale
Interval -5.02 to 12.51
|
6.46 score on a scale
Interval -2.17 to 15.09
|
3.13 score on a scale
Interval -14.2 to 20.47
|
SECONDARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Balance was measured using the Berg Balance Scale (BBS). The score ranges from 0 to 56, with a lower score indicating a higher risk of falling and a higher score indicating better functional mobility. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for TeleCAM and rDirectCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=382 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=375 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=44 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Balance (Berg Balance Scale)
|
3.67 score on a scale
Interval 3.14 to 4.21
|
1.56 score on a scale
Interval 1.02 to 2.11
|
1.93 score on a scale
Interval 0.0 to 3.86
|
SECONDARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Balance was measured by the Five Times Site to Stand (FTSTS) test. Less time (in seconds) used to complete the FTSTS test indicates better balance. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=363 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=367 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=48 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Balance (Five Times Site to Stand)
|
-3.33 seconds
Interval -4.48 to -2.17
|
-2.28 seconds
Interval -3.43 to -1.12
|
-2.45 seconds
Interval -6.64 to 1.74
|
SECONDARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM.Population: The Six-Minute Walk test was not assessed for participants in the rDirectCAM arm.
Endurance was measured using the 6-Minute Walk Test (6MWT). More distance traveled (meters) within the 6 minutes indicates better walking endurance. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=358 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=359 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Endurance
|
28.30 meters
Interval 19.36 to 37.25
|
23.04 meters
Interval 14.1 to 31.99
|
—
|
SECONDARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Gait was measured by the Timed Up and Go (TUG) test. Less time (in seconds) taken to complete the TUG test indicates better gait. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=371 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=370 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=44 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Gait (Timed Up and Go)
|
-2.24 seconds
Interval -4.03 to -0.45
|
-1.20 seconds
Interval -3.0 to 0.6
|
-1.72 seconds
Interval -8.66 to 5.22
|
SECONDARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM.Population: The Time 25-foot Walk was not assessed among the rDirectCAM arm.
Gait was measured using the Timed 25-Foot Walk (T25FW) test. Less time taken to complete the T25FW test indicates better gait. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and TeleCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=366 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=363 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Gait (Timed 25-Foot Walk)
|
-0.86 seconds
Interval -2.86 to 1.15
|
0.48 seconds
Interval -1.53 to 2.5
|
—
|
SECONDARY outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Grip strength was measured using a hand-held dynamometer. The higher score measured in pounds (lbs) indicates better grip strength. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=377 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=365 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=49 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Grip Strength
|
3.11 lbs
Interval 1.54 to 4.67
|
2.68 lbs
Interval 1.1 to 4.26
|
4.35 lbs
Interval -1.11 to 9.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Outcome expectations for exercise was measured by the Multidimensional Outcome Expectations for Exercise Scale (MOEES). The total score ranges from 15 to 75, with a higher score on the MOEES reflects greater positive expectations regarding the outcomes of exercise across the three domains (physical, social, and self-evaluative). The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample sizes for DirectCAM and rDirectCAM reported in this outcome was lower than the sample sizes reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=376 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=377 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=68 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Outcome Expectations for Exercise
|
-1.00 score on a scale
Interval -1.91 to -0.1
|
-0.21 score on a scale
Interval -1.12 to 0.7
|
-0.48 score on a scale
Interval -2.51 to 1.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Exercise self-efficacy was measured by the Exercise Self-Efficacy Scale. The total score ranges from 0 to 100, with higher scores indicate better exercise self-efficacy. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=377 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=376 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=68 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Exercise Self-Efficacy
|
-27.0 score on a scale
Interval -30.24 to -23.7
|
-26.98 score on a scale
Interval -30.25 to -23.69
|
-4.41 score on a scale
Interval -11.35 to 2.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Social support for exercise was measured by the Social Provisions Scale. The score ranges from 24 (1 point for each item) to 96 (4 points for each item), with higher scores indicate higher perceived social support and lower scores suggest lower perceived social support. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=377 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=374 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=68 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Social Support for Exercise
|
1.24 score on a scale
Interval 0.94 to 1.54
|
1.38 score on a scale
Interval 1.08 to 1.69
|
0.33 score on a scale
Interval -0.32 to 0.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.Exercise self-regulation was measured by the Exercise Goal-Setting Scale. The total score ranges from 10 to 50, with a higher score indicates better or more effective goal-setting behaviors in relation to exercise. The change was estimated at Month 12 compared to baseline for DirectCAM and TeleCAM, and at Month 3 compared to baseline for rDirectCAM. The mean difference and 95% confidence interval of this outcome were reported based on mixed models analyzed using intent-to-treat approach, including all available baseline data for the outcome. Please note that while some participants completed baseline, not all outcome measures were completed. As a result, the sample size for each arm reported in this outcome was lower than the sample size reported in the Participant Flow Overview section.
Outcome measures
| Measure |
DirectCAM
n=380 Participants
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=376 Participants
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=68 Participants
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Change in Exercise Self-Regulation
|
0.46 score on a scale
Interval -0.57 to 1.49
|
3.63 score on a scale
Interval 2.6 to 4.67
|
3.71 score on a scale
Interval 1.13 to 6.28
|
Adverse Events
DirectCAM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TeleCAM
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
rDirectCAM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DirectCAM
n=425 participants at risk
The DirectCAM arm receives the intervention content via therapists at participating clinics.
DirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
TeleCAM
n=412 participants at risk
The TeleCAM arm receives the intervention content at home using pre-loaded tablets and Interactive Voice Response (IVR) system technology.
TeleCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
|
rDirectCAM
n=74 participants at risk
The rDirectCAM arm is being implemented in response to Covid-19. The rDirectCAM arm receives the intervention content delivered remotely in real-time by therapists via videoconferencing technology.
rDirectCAM: The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
|
|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/425 • 1 year
|
0.24%
1/412 • Number of events 1 • 1 year
|
0.00%
0/74 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized due to Covid-19
|
0.00%
0/425 • 1 year
|
0.24%
1/412 • Number of events 1 • 1 year
|
0.00%
0/74 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place