Trial Outcomes & Findings for Adapted Lifestyle-integrated Functional Exercise Program for Medically Underserved Older Adults (NCT NCT03704194)
NCT ID: NCT03704194
Last Updated: 2025-08-27
Results Overview
The Berg Balance Scale (BBS) is a 14-item assessment of static and dynamic balance. Performance quality, time, and assistance required are rated on a scale of 0-4 based on pre-specified criteria. Total scores range from 0-56, with a score of 45 or below indicating high risk of falls.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2025-08-27
Participant Flow
Participant milestones
| Measure |
Adapted LiFE
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Adapted LiFE
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Adapted Lifestyle-integrated Functional Exercise Program for Medically Underserved Older Adults
Baseline characteristics by cohort
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
n=9 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.0 years
STANDARD_DEVIATION 4.9 • n=93 Participants
|
77.9 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
77.0 years
STANDARD_DEVIATION 5.8 • n=27 Participants
|
|
Sex: Female, Male
sex · Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
sex · Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who completed the intervention were included in the analysis.
The Berg Balance Scale (BBS) is a 14-item assessment of static and dynamic balance. Performance quality, time, and assistance required are rated on a scale of 0-4 based on pre-specified criteria. Total scores range from 0-56, with a score of 45 or below indicating high risk of falls.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
n=8 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
The Berg Balance Scale (BBS)
Pre-test
|
40.63 score on a scale
Standard Deviation 10.17
|
35.25 score on a scale
Standard Deviation 11.52
|
|
The Berg Balance Scale (BBS)
Post-test
|
38.38 score on a scale
Standard Deviation 12.59
|
35.88 score on a scale
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants in the treatment group were included in the analysis.
The Self-Reported Habit Index (SRHI) is a 12-item assessment assesses habit exercise strength, frequency, relevance to self-identity, and automaticity. Items are self-rated with a seven-point Likert scale (1=strongly disagree, 7= strongly agree). Total score range from 12 to 84, where higher scores indicate stronger the habit is.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
The Self-Reported Habit Index (SRHI)
Post-test
|
57.13 score on a scale
Standard Deviation 19.26
|
—
|
|
The Self-Reported Habit Index (SRHI)
Pre-test
|
47.50 score on a scale
Standard Deviation 21.67
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All participants who completed the interventions were included.
The Activities-specific Balance Confidence Scale (ABC) is 16-item self-report measure in which participates rate their balance confidence for performing activities. Each item is rated on a 0-100 scale (0= no confidence, 100 = complete confidence). A final score is the average of all items ( range from 0 to 100).
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
n=8 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
The Activities-specific Balance Confidence Scale (ABC)
Pre-test
|
60.77 score on a scale
Standard Deviation 20.83
|
52.46 score on a scale
Standard Deviation 22.26
|
|
The Activities-specific Balance Confidence Scale (ABC)
Post-test
|
60.63 score on a scale
Standard Deviation 21.57
|
60.7 score on a scale
Standard Deviation 12.94
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who completed the interventions were included in the analysis.
The Short Physical Performance Battery-Balance Test (SPPB) assess balance and mobility with three subtests (score range: 0 to 4): standing balance, three-meter gait speed, and five repetitions of sit-to-stand motion. Total score are sums of subtest scores ranging from 0 (worst performance) to 12 (best performance).
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
n=8 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
The Short Physical Performance Battery (SPPB)
Pre-test
|
6.38 score on a scale
Standard Deviation 2.83
|
5.25 score on a scale
Standard Deviation 2.87
|
|
The Short Physical Performance Battery (SPPB)
Post-test
|
5.25 score on a scale
Standard Deviation 3.01
|
5.38 score on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who completed the interventions were included in the analysis.
Center of Pressure (Cop) is measured by a balance board system BtracKS. Participant stands on the balance board in 4 posture in three 30-second trials for each posture: hip-width stand (HS), hip-width stand with eyes closed (HSEC), narrow stand (NS), narrow stand with eyes closed (NSEC). Trajectory and mean velocity of CoP in each postures are calculated to represent static balance. Larger trajectory or velocity indicates lower static balance.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
n=8 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
Center of Pressure (CoP) Path (cm)
HS CoP Mean distance (cm) Pre-test
|
0.59 cm
Standard Deviation 0.13
|
0.67 cm
Standard Deviation 0.32
|
|
Center of Pressure (CoP) Path (cm)
HS CoP Mean distance (cm) Post-test
|
0.68 cm
Standard Deviation 0.16
|
0.61 cm
Standard Deviation 0.19
|
|
Center of Pressure (CoP) Path (cm)
HSEC CoP Mean distance (cm) Pre-test
|
0.59 cm
Standard Deviation 0.13
|
0.69 cm
Standard Deviation 0.29
|
|
Center of Pressure (CoP) Path (cm)
HSEC CoP Mean distance (cm) Post-test
|
0.68 cm
Standard Deviation 0.16
|
0.72 cm
Standard Deviation 0.30
|
|
Center of Pressure (CoP) Path (cm)
NS CoP Mean distance (cm) Pre-test
|
0.82 cm
Standard Deviation 0.09
|
0.71 cm
Standard Deviation 0.17
|
|
Center of Pressure (CoP) Path (cm)
NS CoP Mean distance (cm) Post-test
|
1.03 cm
Standard Deviation 0.43
|
0.83 cm
Standard Deviation 0.32
|
|
Center of Pressure (CoP) Path (cm)
NSEC CoP Mean distance (cm) Pre-test
|
1.13 cm
Standard Deviation 0.24
|
0.99 cm
Standard Deviation 0.40
|
|
Center of Pressure (CoP) Path (cm)
NSEC CoP Mean distance (cm) Post-test
|
1.39 cm
Standard Deviation 0.51
|
1.12 cm
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who completed the interventions were included in the analysis.
Center of Pressure (Cop) mean velocity (cm/s) is measured by a balance board system BtracKS. Participant stands on the balance board in 4 posture in three 30-second trials for each posture: hip-width stand (HS), hip-width stand with eyes closed (HSEC), narrow stand (NS), narrow stand with eyes closed (NSEC). Larger velocity indicates a lower static balance.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
n=8 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
Center of Pressure (CoP) Velocity (cm/s)
HS CoP Mean velocity (cm/s) Pre-test
|
2.38 cm/s
Standard Deviation 1.05
|
1.96 cm/s
Standard Deviation 0.55
|
|
Center of Pressure (CoP) Velocity (cm/s)
HS CoP Mean velocity (cm/s) Post-tes
|
2.59 cm/s
Standard Deviation 1.52
|
1.96 cm/s
Standard Deviation 0.74
|
|
Center of Pressure (CoP) Velocity (cm/s)
HSEC CoP Mean velocity (cm/s) Pre-test
|
3.22 cm/s
Standard Deviation 2.03
|
2.89 cm/s
Standard Deviation 1.11
|
|
Center of Pressure (CoP) Velocity (cm/s)
HSEC CoP Mean velocity (cm/s) Post-test
|
4.01 cm/s
Standard Deviation 3.48
|
3.02 cm/s
Standard Deviation 1.12
|
|
Center of Pressure (CoP) Velocity (cm/s)
NS CoP Mean velocity (cm/s) Pre-test
|
3.18 cm/s
Standard Deviation 1.31
|
2.93 cm/s
Standard Deviation 0.75
|
|
Center of Pressure (CoP) Velocity (cm/s)
NS CoP Mean velocity (cm/s) Post-test
|
3.88 cm/s
Standard Deviation 2.20
|
2.45 cm/s
Standard Deviation 1.05
|
|
Center of Pressure (CoP) Velocity (cm/s)
NSEC CoP Mean velocity (cm/s) Pre-test
|
4.55 cm/s
Standard Deviation 1.88
|
4.21 cm/s
Standard Deviation 2.30
|
|
Center of Pressure (CoP) Velocity (cm/s)
NSEC CoP Mean velocity (cm/s) Post-test
|
5.05 cm/s
Standard Deviation 2.38
|
4.30 cm/s
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Participants who completed the interventions were included.
Lower extremity muscle strength of hip and knee are measured by a dynamometer.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
n=8 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
Lower Extremity Muscle Strength
Hip flexors (right limb) Pre-test
|
18.11 pound
Standard Deviation 4.37
|
19.86 pound
Standard Deviation 8.95
|
|
Lower Extremity Muscle Strength
Hip flexors (right limb) Post-test
|
18.73 pound
Standard Deviation 12.55
|
21.58 pound
Standard Deviation 15.75
|
|
Lower Extremity Muscle Strength
Hip flexors (left limb) Pre-test
|
17.10 pound
Standard Deviation 4.94
|
15.97 pound
Standard Deviation 7.67
|
|
Lower Extremity Muscle Strength
Hip flexors (left limb) Post-test
|
19.79 pound
Standard Deviation 13.23
|
19.25 pound
Standard Deviation 8.70
|
|
Lower Extremity Muscle Strength
Knee flexors (right limb) Pre-test
|
23.83 pound
Standard Deviation 2.96
|
24.15 pound
Standard Deviation 8.91
|
|
Lower Extremity Muscle Strength
Knee flexors (right limb) Post-test
|
16.48 pound
Standard Deviation 9.51
|
18.65 pound
Standard Deviation 8.22
|
|
Lower Extremity Muscle Strength
Knee flexors (left limb) Pre-test
|
21.34 pound
Standard Deviation 4.47
|
23.40 pound
Standard Deviation 6.66
|
|
Lower Extremity Muscle Strength
Knee flexors (left limb) Post-test
|
15.01 pound
Standard Deviation 8.61
|
19.1 pound
Standard Deviation 8.77
|
|
Lower Extremity Muscle Strength
Knee extensors (right limb) Pre-test
|
25.38 pound
Standard Deviation 6.90
|
27.38 pound
Standard Deviation 7.53
|
|
Lower Extremity Muscle Strength
Knee extensors (right limb) Post-test
|
22.62 pound
Standard Deviation 9.18
|
27.15 pound
Standard Deviation 10.84
|
|
Lower Extremity Muscle Strength
Knee extensors (left limb) Pre-test
|
23.25 pound
Standard Deviation 8.06
|
26.56 pound
Standard Deviation 6.84
|
|
Lower Extremity Muscle Strength
Knee extensors (left limb) Post-test
|
21 pound
Standard Deviation 9.19
|
26.81 pound
Standard Deviation 11.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: Among 39 potentially eligible participants, 16 successfully enrolled. The 16 enrolled participants were randomized to treatment (n=8) and control (n=8)groups, and all completed the intervention and one-month follow-up, which resulted in a 100% retention rate.
The status of each potential participant we contacted is documented in an electronic therapist log. Treatment and control groups share the same recruitment rate since randomization took place after enrollment, and the two groups were not recruited separately. Recruitment rate will be measured by the percentage of participants successfully enrolled in the study. Retention rate is calculated by the number of participants completed divided by the number of participants enrolled. Retention rate is calculated by the number of participants completed divided by the number of participants enrolled.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
n=8 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
Recruitment and Retention Rate Are Documented by Therapist Logs
Recruitment rate
|
42.02 percentage of participants
|
42.02 percentage of participants
|
|
Recruitment and Retention Rate Are Documented by Therapist Logs
Retention rate
|
100 percentage of participants
|
100 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Participants completed treatment intervention were included.
A question, "Are you satisfied with the program?," using a seven-point Likert scale from one (very unsatisfied) to seven (very satisfied) is used to represent acceptance. Score range: 1-7. Higher values indicate higher satisfaction.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
Acceptance of the Intervention Programs is Measured by a Question.
|
6.88 score on a scale
Standard Deviation 0.35
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Participant in the treatment group.
Participants in the treatment group documents their exercise activities in the LiFE activity calendar. Adherence rate is defined as the average percentage of exercise activities achieved during the intervention period.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
Adherence Rate is Documented by LiFE Activity Calendar
Session 1
|
79 percentage of achieved exercise activity
Standard Deviation 33
|
—
|
|
Adherence Rate is Documented by LiFE Activity Calendar
Session 2
|
87 percentage of achieved exercise activity
Standard Deviation 12
|
—
|
|
Adherence Rate is Documented by LiFE Activity Calendar
Session 3
|
73 percentage of achieved exercise activity
Standard Deviation 23
|
—
|
|
Adherence Rate is Documented by LiFE Activity Calendar
Session 4
|
76 percentage of achieved exercise activity
Standard Deviation 35
|
—
|
|
Adherence Rate is Documented by LiFE Activity Calendar
Session 5
|
73 percentage of achieved exercise activity
Standard Deviation 35
|
—
|
|
Adherence Rate is Documented by LiFE Activity Calendar
Session 6
|
74 percentage of achieved exercise activity
Standard Deviation 34
|
—
|
|
Adherence Rate is Documented by LiFE Activity Calendar
Session 7
|
51 percentage of achieved exercise activity
Standard Deviation 46
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Participants completed the interventions were included.
Therapists in both treatment and control group complete a checklist after every visit. The checklist consist of pre-determined key activities. The number of delivered key activities divided by the number of planned key activities in all visits calculates a fidelity score.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
|
Attention Control
n=8 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
|---|---|---|
|
Fidelity is Documented by a Visit-by-visit Checklist
|
100 percentage of treatment delivery
Standard Deviation 0
|
100 percentage of treatment delivery
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: Participants completed the interventions were included.
Safety of the program will be evaluated by the number of adverse events documented throughout the study duration.
Outcome measures
| Measure |
Adapted LiFE
n=8 Participants
Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Adapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
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Attention Control
n=8 Participants
Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.
Attention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
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Adverse Events
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0 counts of adverse events
Standard Deviation 0
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0 counts of adverse events
Standard Deviation 0
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Adverse Events
Adapted LiFE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place