Trial Outcomes & Findings for Feasibility of Exercise and Spinal Cord Injury (NCT NCT03941600)
NCT ID: NCT03941600
Last Updated: 2023-02-17
Results Overview
VO2 peak will be measured using a standard computer-integrated, open-circuit, breath-by-breath metabolic measurement system (TrueOne 2400, Parvo Medics, Sandy UT) while the participant performs a graded-exercise test on an arm crank ergometer (SCIFIT PRO2, Life Fitness, Tulsa, OK). The protocol involves a 3-minute warm-up followed by a standard ramp protocol which is typically completed in 8-12 minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Baseline and Up to 4 weeks post intervention
Results posted on
2023-02-17
Participant Flow
Participant milestones
| Measure |
Community-based Exercise Intervention Group (CBEI)
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
22
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of Exercise and Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=27 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=22 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
38.04 years
STANDARD_DEVIATION 10.847 • n=5 Participants
|
40.77 years
STANDARD_DEVIATION 15.991 • n=7 Participants
|
39.27 years
STANDARD_DEVIATION 13.323 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
22 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPopulation: Only valid data was analyzed. Data deemed "valid" when the following criteria was met, (before/within 1 minute of cooldown, RER =/\> 1.1, RPE reported as =/\>15. A participant's PRE/POST scores both had to be valid to be included in analysis. CBEI group = 6 participants excluded, 3 did not have any valid VO2 test, 3 only had 1 valid VO2 test. EEG group = 1 did not have any valid VO2 test, 2 only had 1 valid VO2 test, 1 participant was unable to physically complete the test.
VO2 peak will be measured using a standard computer-integrated, open-circuit, breath-by-breath metabolic measurement system (TrueOne 2400, Parvo Medics, Sandy UT) while the participant performs a graded-exercise test on an arm crank ergometer (SCIFIT PRO2, Life Fitness, Tulsa, OK). The protocol involves a 3-minute warm-up followed by a standard ramp protocol which is typically completed in 8-12 minutes.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=9 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=13 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)
Pre
|
14.69 ml/kg/min
Standard Error 1.22
|
14.36 ml/kg/min
Standard Error 1.28
|
|
VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)
Post
|
15.61 ml/kg/min
Standard Error 1.95
|
13.74 ml/kg/min
Standard Error 1.09
|
PRIMARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPopulation: Only 2 participants (both from the CBEI group) were able to complete this outcome measure due to the COVID-19 pandemic. Our research project was considered non-essential and therefore the services to conduct these assessments were shut down and not available.
Participants will then undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety. Body fat % will be the unit of measure.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=2 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
DEXA - Body Composition Overall Body Fat % Change
Pre
|
39.800 percentage of body fat
Standard Error .1000
|
—
|
|
DEXA - Body Composition Overall Body Fat % Change
Post
|
38.750 percentage of body fat
Standard Error 2.2500
|
—
|
PRIMARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPopulation: This data was only collected on 2 participants (1 CBEI group and 1 EEG group) at the pre-assessment period and 3 participants (2 CBEI group and 1 EEG group) at post assessment. We were not able to complete this outcome measure on any further participants due to the COVID-19 pandemic. Our research project was considered non-essential and therefore the services to conduct these assessments were shut down and not available.
Blood draws will be completed to measure HbA1c levels in %. Participants will fast 8-10 hours prior to blood draw.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=2 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=1 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
Metabolic Blood Chemistries - HbA1c Level Change
Pre
|
4.9 percentage of HbA1c levels
|
5.0 percentage of HbA1c levels
|
|
Metabolic Blood Chemistries - HbA1c Level Change
Post
|
4.9 percentage of HbA1c levels
Standard Error .4000
|
5.0 percentage of HbA1c levels
|
PRIMARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionsPopulation: Only 3 participants (2 CBEI and 1 EEG) were able to complete this outcome measure due to the COVID-19 pandemic. Our research project was considered non-essential and therefore the services to conduct these assessments were shut down and not available.
Blood draws will be completed to measure cholesterol levels. Unit of measure will be in mg/dL. Participants will fast 8-10 hours prior to blood draw.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=2 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=1 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
Metabolic Blood Chemistries - Cholesterol Change
Pre
|
172 mg/dL
Standard Error 39
|
188 mg/dL
|
|
Metabolic Blood Chemistries - Cholesterol Change
Post
|
170. mg/dL
Standard Error 50
|
212 mg/dL
|
SECONDARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPopulation: 1 participant from the Excercise Education Control group (EEG) was unable to do the PRE upper extremity strength measure at baseline.
Strength will be measured via isotonic 1RM testing unilaterally on four upper-extremity exercises (chest press, back row, rickshaw, biceps flexion) using a BTE™ PrimusRS (BTE™, Hanover, MD). Data was organized into one single strength variable by summing the 4 left side upper extremity exercises together, then summing the 4 right side upper extremity exercises together, and finally taking those 2 totals (from left side and right side) and summing them into one strength variable. A higher number indicates more strength. The BTE™ PrimusRS uses an inch-pound (the torque of one pound of force applied to one inch of distance from the pivot) as it's unit of measurement.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=15 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=17 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
Upper Extremity Strength - Upper Body Strength Change
Pre
|
287.83 inch-pound
Standard Error 29.87
|
277.0 inch-pound
Standard Error 28.17
|
|
Upper Extremity Strength - Upper Body Strength Change
Post
|
351.37 inch-pound
Standard Error 31.89
|
315.47 inch-pound
Standard Error 29.44
|
SECONDARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPatient Reported Outcomes Measurement Information System (PROMIS) Fatigue - assesses a range of self-reported fatigue symptoms over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "not at all (1)" to "very much (5)" with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild fatigue, a t-score of 60-70 indicates moderate fatigue and a t-score of 70 or above indicates severe fatigue.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=15 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=17 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
PROMIS - Fatigue Short Form 8a
Pre
|
48.09 T-score
Standard Error 1.49
|
49.31 T-score
Standard Error 2.53
|
|
PROMIS - Fatigue Short Form 8a
Post
|
46.71 T-score
Standard Error 1.66
|
50.43 T-score
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPatient Reported Outcomes Measurement Information System (PROMIS) Emotional distress - Depression - assesses self-reported negative mood, views of self, social cognition, as well as decreased positive affect and engagement over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "never (1)" to "always (5)" with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild depression, a t-score of 60-70 indicates moderate depression and a t-score of 70 or above indicates severe depression.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=15 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=17 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
PROMIS - Emotional Distress - Depression - Short Form 8a
Pre
|
47.21 T-score
Standard Error 2.36
|
51.44 T-score
Standard Error 2.92
|
|
PROMIS - Emotional Distress - Depression - Short Form 8a
Post
|
45.31 T-score
Standard Error 1.75
|
51.69 T-score
Standard Error 2.48
|
SECONDARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPatient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity - assesses how much a person hurts over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "had no pain (1)" to "very severe (5)" with a raw score between 3 and 15. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild pain intensity, a t-score of 60-70 indicates moderate pain intensity and a t-score of 70 or above indicates severe pain intensity.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=15 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=17 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
PROMIS - Pain Intensity - Short Form 3a
Pre
|
46.23 T-score
Standard Error 3.37
|
45.08 T-score
Standard Error 2.10
|
|
PROMIS - Pain Intensity - Short Form 3a
Post
|
45.01 T-score
Standard Error 3.23
|
45.43 T-score
Standard Error 2.52
|
SECONDARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPatient Reported Outcomes Measurement Information System (PROMIS) Pain Interference - assesses self-reported consequences of pain on relevant aspects of one's life over the past 7 days, this includes how pain hinders engagement with social, cognitive, emotional, physical and recreational activities. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "not at all (1)" to "very much (5)" with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild pain interference, a t-score of 60-70 indicates moderate pain interference and a t-score of 70 or above indicates severe pain interference.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=15 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=17 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
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|---|---|---|
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PROMIS - Pain Interference - Short Form 8a
Pre
|
52.24 T-score
Standard Error 2.6
|
52.06 T-score
Standard Error 2.51
|
|
PROMIS - Pain Interference - Short Form 8a
Post
|
52.64 T-score
Standard Error 2.64
|
51.96 T-score
Standard Error 2.17
|
SECONDARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPatient Reported Outcomes Measurement Information System (PROMIS) Sleep - assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "very poor (1)" to "very good (5)" with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild sleep disturbance, a t-score of 60-70 indicates moderate sleep disturbance and a t-score of 70 or above indicates severe sleep disturbance.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=15 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=17 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
PROMIS - Sleep Disturbance - Short Form 8a
Pre
|
48.71 T-score
Standard Error 2.36
|
50.48 T-score
Standard Error 2.63
|
|
PROMIS - Sleep Disturbance - Short Form 8a
Post
|
48.87 T-score
Standard Error 3.49
|
51.31 T-score
Standard Error 2.77
|
SECONDARY outcome
Timeframe: Baseline and Up to 4 weeks post interventionPopulation: One participant within the Community-based Exercise Intervention group (CBEI) post data was missing, therefore only 14 were analyzed instead of 15
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support - assesses perceived feelings of being cared for and valued as a person and having confident relationships. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "never (1)" to "always (5)". The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 40-60 indicates an average amount of emotional support, a t-score of 60-70 indicates high levels of emotional support, and a t-score of 70 or above indicates very high levels of emotional support.
Outcome measures
| Measure |
Community-based Exercise Intervention Group (CBEI)
n=15 Participants
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
|
Exercise Education Control Group (EEG)
n=17 Participants
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
|
|---|---|---|
|
PROMIS - Emotional Support
Pre
|
55.77 T-score
Standard Error 2.47
|
49.66 T-score
Standard Error 1.94
|
|
PROMIS - Emotional Support
Post
|
55.01 T-score
Standard Error 2.39
|
49.58 T-score
Standard Error 1.63
|
Adverse Events
Community-based Exercise Intervention Group (CBEI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise Education Control Group (EEG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kerri Morgan
Washington University School of Medicine
Phone: 314-286-1659
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place