70 and older, any sex, with Accidental Fall. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Berg Balance Scale (BBS)Primary· Baseline and 12 weeks
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.
Pre-test
Group
Value
95% CI
Adapted LiFE
40.63
± 10.17
Attention Control
35.25
± 11.52
Post-test
Group
Value
95% CI
Adapted LiFE
38.38
± 12.59
Attention Control
35.88
± 9.85
The Self-Reported Habit Index (SRHI)Secondary· Baseline and 12 weeks
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.
Pre-test
Group
Value
95% CI
Adapted LiFE
47.50
± 21.67
Post-test
Group
Value
95% CI
Adapted LiFE
57.13
± 19.26
The Activities-specific Balance Confidence Scale (ABC)Secondary· 12 weeks
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).
Pre-test
Group
Value
95% CI
Adapted LiFE
60.77
± 20.83
Attention Control
52.46
± 22.26
Post-test
Group
Value
95% CI
Adapted LiFE
60.63
± 21.57
Attention Control
60.7
± 12.94
The Short Physical Performance Battery (SPPB)Secondary· Baseline and 12 weeks
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).
Pre-test
Group
Value
95% CI
Adapted LiFE
6.38
± 2.83
Attention Control
5.25
± 2.87
Post-test
Group
Value
95% CI
Adapted LiFE
5.25
± 3.01
Attention Control
5.38
± 2.20
Center of Pressure (CoP) Path (cm)Secondary· Baseline and 12 weeks
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.
HS CoP Mean distance (cm) Pre-test
Group
Value
95% CI
Adapted LiFE
0.59
± 0.13
Attention Control
0.67
± 0.32
HS CoP Mean distance (cm) Post-test
Group
Value
95% CI
Adapted LiFE
0.68
± 0.16
Attention Control
0.61
± 0.19
HSEC CoP Mean distance (cm) Pre-test
Group
Value
95% CI
Adapted LiFE
0.59
± 0.13
Attention Control
0.69
± 0.29
HSEC CoP Mean distance (cm) Post-test
Group
Value
95% CI
Adapted LiFE
0.68
± 0.16
Attention Control
0.72
± 0.30
NS CoP Mean distance (cm) Pre-test
Group
Value
95% CI
Adapted LiFE
0.82
± 0.09
Attention Control
0.71
± 0.17
NS CoP Mean distance (cm) Post-test
Group
Value
95% CI
Adapted LiFE
1.03
± 0.43
Attention Control
0.83
± 0.32
NSEC CoP Mean distance (cm) Pre-test
Group
Value
95% CI
Adapted LiFE
1.13
± 0.24
Attention Control
0.99
± 0.40
NSEC CoP Mean distance (cm) Post-test
Group
Value
95% CI
Adapted LiFE
1.39
± 0.51
Attention Control
1.12
± 0.54
Center of Pressure (CoP) Velocity (cm/s)Secondary· Baseline and 12 weeks
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.
HS CoP Mean velocity (cm/s) Pre-test
Group
Value
95% CI
Adapted LiFE
2.38
± 1.05
Attention Control
1.96
± 0.55
HS CoP Mean velocity (cm/s) Post-tes
Group
Value
95% CI
Adapted LiFE
2.59
± 1.52
Attention Control
1.96
± 0.74
HSEC CoP Mean velocity (cm/s) Pre-test
Group
Value
95% CI
Adapted LiFE
3.22
± 2.03
Attention Control
2.89
± 1.11
HSEC CoP Mean velocity (cm/s) Post-test
Group
Value
95% CI
Adapted LiFE
4.01
± 3.48
Attention Control
3.02
± 1.12
NS CoP Mean velocity (cm/s) Pre-test
Group
Value
95% CI
Adapted LiFE
3.18
± 1.31
Attention Control
2.93
± 0.75
NS CoP Mean velocity (cm/s) Post-test
Group
Value
95% CI
Adapted LiFE
3.88
± 2.20
Attention Control
2.45
± 1.05
NSEC CoP Mean velocity (cm/s) Pre-test
Group
Value
95% CI
Adapted LiFE
4.55
± 1.88
Attention Control
4.21
± 2.30
NSEC CoP Mean velocity (cm/s) Post-test
Group
Value
95% CI
Adapted LiFE
5.05
± 2.38
Attention Control
4.30
± 2.53
Lower Extremity Muscle StrengthSecondary· Baseline and 12 weeks
Lower extremity muscle strength of hip and knee are measured by a dynamometer.
Hip flexors (right limb) Pre-test
Group
Value
95% CI
Adapted LiFE
18.11
± 4.37
Attention Control
19.86
± 8.95
Hip flexors (right limb) Post-test
Group
Value
95% CI
Adapted LiFE
18.73
± 12.55
Attention Control
21.58
± 15.75
Hip flexors (left limb) Pre-test
Group
Value
95% CI
Adapted LiFE
17.10
± 4.94
Attention Control
15.97
± 7.67
Hip flexors (left limb) Post-test
Group
Value
95% CI
Adapted LiFE
19.79
± 13.23
Attention Control
19.25
± 8.70
Knee flexors (right limb) Pre-test
Group
Value
95% CI
Adapted LiFE
23.83
± 2.96
Attention Control
24.15
± 8.91
Knee flexors (right limb) Post-test
Group
Value
95% CI
Adapted LiFE
16.48
± 9.51
Attention Control
18.65
± 8.22
Knee flexors (left limb) Pre-test
Group
Value
95% CI
Adapted LiFE
21.34
± 4.47
Attention Control
23.40
± 6.66
Knee flexors (left limb) Post-test
Group
Value
95% CI
Adapted LiFE
15.01
± 8.61
Attention Control
19.1
± 8.77
Recruitment and Retention Rate Are Documented by Therapist LogsSecondary· 16 weeks
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.
Recruitment rate
Group
Value
95% CI
Attention Control
42.02
Adapted LiFE
42.02
Retention rate
Group
Value
95% CI
Attention Control
100
Adapted LiFE
100
Acceptance of the Intervention Programs is Measured by a Question.Secondary· 12 weeks
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.
Group
Value
95% CI
Adapted LiFE
6.88
± 0.35
Adherence Rate is Documented by LiFE Activity CalendarSecondary· 12 weeks
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.
Session 1
Group
Value
95% CI
Adapted LiFE
79
± 33
Session 2
Group
Value
95% CI
Adapted LiFE
87
± 12
Session 3
Group
Value
95% CI
Adapted LiFE
73
± 23
Session 4
Group
Value
95% CI
Adapted LiFE
76
± 35
Session 5
Group
Value
95% CI
Adapted LiFE
73
± 35
Session 6
Group
Value
95% CI
Adapted LiFE
74
± 34
Session 7
Group
Value
95% CI
Adapted LiFE
51
± 46
Fidelity is Documented by a Visit-by-visit ChecklistSecondary· 12 weeks
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.
Group
Value
95% CI
Adapted LiFE
100
± 0
Attention Control
100
± 0
Adverse EventsSecondary· 16 weeks
Safety of the program will be evaluated by the number of adverse events documented throughout the study duration.
Group
Value
95% CI
Adapted LiFE
0
± 0
Attention Control
0
± 0
Sponsor's own description
This study will test the feasibility of a study design for the Adapted Lifestyle-integrated Functional Exercise (LiFE) program for medically underserved older adults and to explore factors related to implementation. A feasibility trial will be conducted with a total of 16 participants. The control group will receive flexibility exercise program as attention control.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 27 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03704194.