Accidental Fall
Conditions
Keywords
falls, exercise program, medically underserved
Brief summary
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.
Detailed description
This study will test the feasibility the Adapted Lifestyle-integrated Functional Exercise (LiFE) program among medically underserved older adults. Sixteen medically underserved older adults will be recruited in the study and randomized to Adapted LiFE or attention control group (flexibility exercise program). Process outcomes and preliminary outcomes will be collected to determine feasibility and preliminary efficacy. Process outcomes such as reach, acceptance, adherence, fidelity, and safety will also be collected throughout the study. Preliminary efficacy outcomes include habit formation, balance, muscle strength will be collected at baseline and at immediately after intervention is completed.
Interventions
BEHAVIORALAdapted 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.
BEHAVIORALAttention 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
randomized controlled feasibility trial
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* (1) age 70 or older; * (2) live independently; * (3) live in a medically underserved/health professional shortage area; * (4) self-report two falls or one injurious fall.
Exclusion criteria
* (1) Short Blessed Test score ≥8, indicating cognitive impairment consistent with dementia; * (2) inability to stand independently with a walking device; * (3) having a serious health condition with a physician's order where exercise is contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Berg Balance Scale (BBS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Activities-specific Balance Confidence Scale (ABC) | 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). |
| The Self-Reported Habit Index (SRHI) | 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. |
| The Short Physical Performance Battery (SPPB) | 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). |
| Center of Pressure (CoP) Path (cm) | 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. |
| Center of Pressure (CoP) Velocity (cm/s) | 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. |
| Lower Extremity Muscle Strength | Baseline and 12 weeks | Lower extremity muscle strength of hip and knee are measured by a dynamometer. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence Rate is Documented by LiFE Activity Calendar | 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. |
| Fidelity is Documented by a Visit-by-visit Checklist | 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. |
| Adverse Events | 16 weeks | Safety of the program will be evaluated by the number of adverse events documented throughout the study duration. |
| Acceptance of the Intervention Programs is Measured by a Question. | 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. |
| Recruitment and Retention Rate Are Documented by Therapist Logs | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 9 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Adapted LiFE | Attention Control |
|---|---|---|---|
| Age, Continuous | 77.0 years STANDARD_DEVIATION 5.8 | 76.0 years STANDARD_DEVIATION 4.9 | 77.9 years STANDARD_DEVIATION 6.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male sex Female | 12 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male sex Male | 5 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
The Berg Balance Scale (BBS)
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.
Time frame: Baseline and 12 weeks
Population: Participants who completed the intervention were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted LiFE | The Berg Balance Scale (BBS) | Pre-test | 40.63 score on a scale | Standard Deviation 10.17 |
| Adapted LiFE | The Berg Balance Scale (BBS) | Post-test | 38.38 score on a scale | Standard Deviation 12.59 |
| Attention Control | The Berg Balance Scale (BBS) | Pre-test | 35.25 score on a scale | Standard Deviation 11.52 |
| Attention Control | The Berg Balance Scale (BBS) | Post-test | 35.88 score on a scale | Standard Deviation 9.85 |
Secondary
Center of Pressure (CoP) Path (cm)
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.
Time frame: Baseline and 12 weeks
Population: Participants who completed the interventions were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted LiFE | Center of Pressure (CoP) Path (cm) | NSEC CoP Mean distance (cm) Post-test | 1.39 cm | Standard Deviation 0.51 |
| Adapted LiFE | Center of Pressure (CoP) Path (cm) | HSEC CoP Mean distance (cm) Pre-test | 0.59 cm | Standard Deviation 0.13 |
| Adapted LiFE | Center of Pressure (CoP) Path (cm) | HSEC CoP Mean distance (cm) Post-test | 0.68 cm | Standard Deviation 0.16 |
| Adapted LiFE | Center of Pressure (CoP) Path (cm) | NS CoP Mean distance (cm) Pre-test | 0.82 cm | Standard Deviation 0.09 |
| Adapted LiFE | Center of Pressure (CoP) Path (cm) | NS CoP Mean distance (cm) Post-test | 1.03 cm | Standard Deviation 0.43 |
| Adapted LiFE | Center of Pressure (CoP) Path (cm) | NSEC CoP Mean distance (cm) Pre-test | 1.13 cm | Standard Deviation 0.24 |
| Adapted LiFE | Center of Pressure (CoP) Path (cm) | HS CoP Mean distance (cm) Pre-test | 0.59 cm | Standard Deviation 0.13 |
| Adapted LiFE | Center of Pressure (CoP) Path (cm) | HS CoP Mean distance (cm) Post-test | 0.68 cm | Standard Deviation 0.16 |
| Attention Control | Center of Pressure (CoP) Path (cm) | HS CoP Mean distance (cm) Post-test | 0.61 cm | Standard Deviation 0.19 |
| Attention Control | Center of Pressure (CoP) Path (cm) | NSEC CoP Mean distance (cm) Post-test | 1.12 cm | Standard Deviation 0.54 |
| Attention Control | Center of Pressure (CoP) Path (cm) | NS CoP Mean distance (cm) Post-test | 0.83 cm | Standard Deviation 0.32 |
| Attention Control | Center of Pressure (CoP) Path (cm) | HSEC CoP Mean distance (cm) Pre-test | 0.69 cm | Standard Deviation 0.29 |
| Attention Control | Center of Pressure (CoP) Path (cm) | HS CoP Mean distance (cm) Pre-test | 0.67 cm | Standard Deviation 0.32 |
| Attention Control | Center of Pressure (CoP) Path (cm) | HSEC CoP Mean distance (cm) Post-test | 0.72 cm | Standard Deviation 0.3 |
| Attention Control | Center of Pressure (CoP) Path (cm) | NSEC CoP Mean distance (cm) Pre-test | 0.99 cm | Standard Deviation 0.4 |
| Attention Control | Center of Pressure (CoP) Path (cm) | NS CoP Mean distance (cm) Pre-test | 0.71 cm | Standard Deviation 0.17 |
Secondary
Center of Pressure (CoP) Velocity (cm/s)
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.
Time frame: Baseline and 12 weeks
Population: Participants who completed the interventions were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted LiFE | Center of Pressure (CoP) Velocity (cm/s) | HSEC CoP Mean velocity (cm/s) Post-test | 4.01 cm/s | Standard Deviation 3.48 |
| Adapted LiFE | Center of Pressure (CoP) Velocity (cm/s) | NS CoP Mean velocity (cm/s) Pre-test | 3.18 cm/s | Standard Deviation 1.31 |
| Adapted LiFE | Center of Pressure (CoP) Velocity (cm/s) | NS CoP Mean velocity (cm/s) Post-test | 3.88 cm/s | Standard Deviation 2.2 |
| Adapted LiFE | Center of Pressure (CoP) Velocity (cm/s) | HS CoP Mean velocity (cm/s) Post-tes | 2.59 cm/s | Standard Deviation 1.52 |
| Adapted LiFE | Center of Pressure (CoP) Velocity (cm/s) | NSEC CoP Mean velocity (cm/s) Pre-test | 4.55 cm/s | Standard Deviation 1.88 |
| Adapted LiFE | Center of Pressure (CoP) Velocity (cm/s) | HS CoP Mean velocity (cm/s) Pre-test | 2.38 cm/s | Standard Deviation 1.05 |
| Adapted LiFE | Center of Pressure (CoP) Velocity (cm/s) | NSEC CoP Mean velocity (cm/s) Post-test | 5.05 cm/s | Standard Deviation 2.38 |
| Adapted LiFE | Center of Pressure (CoP) Velocity (cm/s) | HSEC CoP Mean velocity (cm/s) Pre-test | 3.22 cm/s | Standard Deviation 2.03 |
| Attention Control | Center of Pressure (CoP) Velocity (cm/s) | NSEC CoP Mean velocity (cm/s) Post-test | 4.30 cm/s | Standard Deviation 2.53 |
| Attention Control | Center of Pressure (CoP) Velocity (cm/s) | NS CoP Mean velocity (cm/s) Pre-test | 2.93 cm/s | Standard Deviation 0.75 |
| Attention Control | Center of Pressure (CoP) Velocity (cm/s) | HS CoP Mean velocity (cm/s) Pre-test | 1.96 cm/s | Standard Deviation 0.55 |
| Attention Control | Center of Pressure (CoP) Velocity (cm/s) | HS CoP Mean velocity (cm/s) Post-tes | 1.96 cm/s | Standard Deviation 0.74 |
| Attention Control | Center of Pressure (CoP) Velocity (cm/s) | HSEC CoP Mean velocity (cm/s) Post-test | 3.02 cm/s | Standard Deviation 1.12 |
| Attention Control | Center of Pressure (CoP) Velocity (cm/s) | NS CoP Mean velocity (cm/s) Post-test | 2.45 cm/s | Standard Deviation 1.05 |
| Attention Control | Center of Pressure (CoP) Velocity (cm/s) | NSEC CoP Mean velocity (cm/s) Pre-test | 4.21 cm/s | Standard Deviation 2.3 |
| Attention Control | Center of Pressure (CoP) Velocity (cm/s) | HSEC CoP Mean velocity (cm/s) Pre-test | 2.89 cm/s | Standard Deviation 1.11 |
Secondary
Lower Extremity Muscle Strength
Lower extremity muscle strength of hip and knee are measured by a dynamometer.
Time frame: Baseline and 12 weeks
Population: Participants who completed the interventions were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted LiFE | Lower Extremity Muscle Strength | Knee extensors (right limb) Post-test | 22.62 pound | Standard Deviation 9.18 |
| Adapted LiFE | Lower Extremity Muscle Strength | Knee flexors (right limb) Pre-test | 23.83 pound | Standard Deviation 2.96 |
| Adapted LiFE | Lower Extremity Muscle Strength | Hip flexors (right limb) Pre-test | 18.11 pound | Standard Deviation 4.37 |
| Adapted LiFE | Lower Extremity Muscle Strength | Hip flexors (right limb) Post-test | 18.73 pound | Standard Deviation 12.55 |
| Adapted LiFE | Lower Extremity Muscle Strength | Hip flexors (left limb) Pre-test | 17.10 pound | Standard Deviation 4.94 |
| Adapted LiFE | Lower Extremity Muscle Strength | Hip flexors (left limb) Post-test | 19.79 pound | Standard Deviation 13.23 |
| Adapted LiFE | Lower Extremity Muscle Strength | Knee flexors (right limb) Post-test | 16.48 pound | Standard Deviation 9.51 |
| Adapted LiFE | Lower Extremity Muscle Strength | Knee flexors (left limb) Pre-test | 21.34 pound | Standard Deviation 4.47 |
| Adapted LiFE | Lower Extremity Muscle Strength | Knee flexors (left limb) Post-test | 15.01 pound | Standard Deviation 8.61 |
| Adapted LiFE | Lower Extremity Muscle Strength | Knee extensors (right limb) Pre-test | 25.38 pound | Standard Deviation 6.9 |
| Adapted LiFE | Lower Extremity Muscle Strength | Knee extensors (left limb) Pre-test | 23.25 pound | Standard Deviation 8.06 |
| Adapted LiFE | Lower Extremity Muscle Strength | Knee extensors (left limb) Post-test | 21 pound | Standard Deviation 9.19 |
| Attention Control | Lower Extremity Muscle Strength | Knee extensors (left limb) Pre-test | 26.56 pound | Standard Deviation 6.84 |
| Attention Control | Lower Extremity Muscle Strength | Knee extensors (right limb) Post-test | 27.15 pound | Standard Deviation 10.84 |
| Attention Control | Lower Extremity Muscle Strength | Hip flexors (left limb) Post-test | 19.25 pound | Standard Deviation 8.7 |
| Attention Control | Lower Extremity Muscle Strength | Knee flexors (right limb) Post-test | 18.65 pound | Standard Deviation 8.22 |
| Attention Control | Lower Extremity Muscle Strength | Knee flexors (right limb) Pre-test | 24.15 pound | Standard Deviation 8.91 |
| Attention Control | Lower Extremity Muscle Strength | Knee extensors (right limb) Pre-test | 27.38 pound | Standard Deviation 7.53 |
| Attention Control | Lower Extremity Muscle Strength | Hip flexors (right limb) Pre-test | 19.86 pound | Standard Deviation 8.95 |
| Attention Control | Lower Extremity Muscle Strength | Knee flexors (left limb) Pre-test | 23.40 pound | Standard Deviation 6.66 |
| Attention Control | Lower Extremity Muscle Strength | Hip flexors (right limb) Post-test | 21.58 pound | Standard Deviation 15.75 |
| Attention Control | Lower Extremity Muscle Strength | Knee extensors (left limb) Post-test | 26.81 pound | Standard Deviation 11.15 |
| Attention Control | Lower Extremity Muscle Strength | Hip flexors (left limb) Pre-test | 15.97 pound | Standard Deviation 7.67 |
| Attention Control | Lower Extremity Muscle Strength | Knee flexors (left limb) Post-test | 19.1 pound | Standard Deviation 8.77 |
Secondary
The Activities-specific Balance Confidence Scale (ABC)
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).
Time frame: 12 weeks
Population: All participants who completed the interventions were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted LiFE | The Activities-specific Balance Confidence Scale (ABC) | Pre-test | 60.77 score on a scale | Standard Deviation 20.83 |
| Adapted LiFE | The Activities-specific Balance Confidence Scale (ABC) | Post-test | 60.63 score on a scale | Standard Deviation 21.57 |
| Attention Control | The Activities-specific Balance Confidence Scale (ABC) | Post-test | 60.7 score on a scale | Standard Deviation 12.94 |
| Attention Control | The Activities-specific Balance Confidence Scale (ABC) | Pre-test | 52.46 score on a scale | Standard Deviation 22.26 |
Secondary
The Self-Reported Habit Index (SRHI)
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.
Time frame: Baseline and 12 weeks
Population: Participants in the treatment group were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted LiFE | The Self-Reported Habit Index (SRHI) | Pre-test | 47.50 score on a scale | Standard Deviation 21.67 |
| Adapted LiFE | The Self-Reported Habit Index (SRHI) | Post-test | 57.13 score on a scale | Standard Deviation 19.26 |
Secondary
The Short Physical Performance Battery (SPPB)
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).
Time frame: Baseline and 12 weeks
Population: Participants who completed the interventions were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted LiFE | The Short Physical Performance Battery (SPPB) | Pre-test | 6.38 score on a scale | Standard Deviation 2.83 |
| Adapted LiFE | The Short Physical Performance Battery (SPPB) | Post-test | 5.25 score on a scale | Standard Deviation 3.01 |
| Attention Control | The Short Physical Performance Battery (SPPB) | Pre-test | 5.25 score on a scale | Standard Deviation 2.87 |
| Attention Control | The Short Physical Performance Battery (SPPB) | Post-test | 5.38 score on a scale | Standard Deviation 2.2 |
Other Pre-specified
Acceptance of the Intervention Programs is Measured by a Question.
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.
Time frame: 12 weeks
Population: Participants completed treatment intervention were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapted LiFE | Acceptance of the Intervention Programs is Measured by a Question. | 6.88 score on a scale | Standard Deviation 0.35 |
Other Pre-specified
Adherence Rate is Documented by LiFE Activity Calendar
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.
Time frame: 12 weeks
Population: Participant in the treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted LiFE | Adherence Rate is Documented by LiFE Activity Calendar | Session 3 | 73 percentage of achieved exercise activity | Standard Deviation 23 |
| Adapted LiFE | Adherence Rate is Documented by LiFE Activity Calendar | Session 4 | 76 percentage of achieved exercise activity | Standard Deviation 35 |
| Adapted LiFE | Adherence Rate is Documented by LiFE Activity Calendar | Session 1 | 79 percentage of achieved exercise activity | Standard Deviation 33 |
| Adapted LiFE | Adherence Rate is Documented by LiFE Activity Calendar | Session 2 | 87 percentage of achieved exercise activity | Standard Deviation 12 |
| Adapted LiFE | Adherence Rate is Documented by LiFE Activity Calendar | Session 5 | 73 percentage of achieved exercise activity | Standard Deviation 35 |
| Adapted LiFE | Adherence Rate is Documented by LiFE Activity Calendar | Session 6 | 74 percentage of achieved exercise activity | Standard Deviation 34 |
| Adapted LiFE | Adherence Rate is Documented by LiFE Activity Calendar | Session 7 | 51 percentage of achieved exercise activity | Standard Deviation 46 |
Other Pre-specified
Adverse Events
Safety of the program will be evaluated by the number of adverse events documented throughout the study duration.
Time frame: 16 weeks
Population: Participants completed the interventions were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapted LiFE | Adverse Events | 0 counts of adverse events | Standard Deviation 0 |
| Attention Control | Adverse Events | 0 counts of adverse events | Standard Deviation 0 |
Other Pre-specified
Fidelity is Documented by a Visit-by-visit Checklist
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.
Time frame: 12 weeks
Population: Participants completed the interventions were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adapted LiFE | Fidelity is Documented by a Visit-by-visit Checklist | 100 percentage of treatment delivery | Standard Deviation 0 |
| Attention Control | Fidelity is Documented by a Visit-by-visit Checklist | 100 percentage of treatment delivery | Standard Deviation 0 |
Other Pre-specified
Recruitment and Retention Rate Are Documented by Therapist Logs
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.
Time frame: 16 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adapted LiFE | Recruitment and Retention Rate Are Documented by Therapist Logs | Recruitment rate | 42.02 percentage of participants |
| Adapted LiFE | Recruitment and Retention Rate Are Documented by Therapist Logs | Retention rate | 100 percentage of participants |
| Attention Control | Recruitment and Retention Rate Are Documented by Therapist Logs | Recruitment rate | 42.02 percentage of participants |
| Attention Control | Recruitment and Retention Rate Are Documented by Therapist Logs | Retention rate | 100 percentage of participants |