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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted LiFE | Experimental | 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. |
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| Attention control | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted LiFE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Stark, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
The results are not published yet.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who completed the intervention were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
Adverse event data were collected through a 16-week period when a participant was enrolled in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brittany Minor | Washington university in St.louis | 314-273-4118 | bminor@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2018 | Jul 9, 2020 | Prot_SAP_000.pdf |
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randomized controlled feasibility trial
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| Attention control | Behavioral | 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) | 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). | 12 weeks |
| 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). | Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| 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. | Baseline and 12 weeks |
| Lower Extremity Muscle Strength | Lower extremity muscle strength of hip and knee are measured by a dynamometer. | Baseline and 12 weeks |
| 16 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| Adverse Events | Safety of the program will be evaluated by the number of adverse events documented throughout the study duration. | 16 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. |
|
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| 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. | Participants in the treatment group were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| 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). | All participants who completed the interventions were included. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| 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). | Participants who completed the interventions were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| 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. | Participants who completed the interventions were included in the analysis. | Posted | Mean | Standard Deviation | cm | Baseline and 12 weeks |
|
|
|
| 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. | Participants who completed the interventions were included in the analysis. | Posted | Mean | Standard Deviation | cm/s | Baseline and 12 weeks |
|
|
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| Secondary | Lower Extremity Muscle Strength | Lower extremity muscle strength of hip and knee are measured by a dynamometer. | Participants who completed the interventions were included. | Posted | Mean | Standard Deviation | pound | Baseline and 12 weeks |
|
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| 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. | 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. | Posted | Number | percentage of participants | 16 weeks |
|
|
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| 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. | Participants completed treatment intervention were included. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| 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. | Participant in the treatment group. | Posted | Mean | Standard Deviation | percentage of achieved exercise activity | 12 weeks |
|
|
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| 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. | Participants completed the interventions were included. | Posted | Mean | Standard Deviation | percentage of treatment delivery | 12 weeks |
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| Other Pre-specified | Adverse Events | Safety of the program will be evaluated by the number of adverse events documented throughout the study duration. | Participants completed the interventions were included. | Posted | Mean | Standard Deviation | counts of adverse events | 16 weeks |
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|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| HSEC CoP Mean distance (cm) Pre-test |
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| HSEC CoP Mean distance (cm) Post-test |
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| NS CoP Mean distance (cm) Pre-test |
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| NS CoP Mean distance (cm) Post-test |
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| NSEC CoP Mean distance (cm) Pre-test |
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| NSEC CoP Mean distance (cm) Post-test |
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| HSEC CoP Mean velocity (cm/s) Pre-test |
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| HSEC CoP Mean velocity (cm/s) Post-test |
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| NS CoP Mean velocity (cm/s) Pre-test |
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| NS CoP Mean velocity (cm/s) Post-test |
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| NSEC CoP Mean velocity (cm/s) Pre-test |
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| NSEC CoP Mean velocity (cm/s) Post-test |
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| Hip flexors (left limb) Pre-test |
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| Hip flexors (left limb) Post-test |
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| Knee flexors (right limb) Pre-test |
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| Knee flexors (right limb) Post-test |
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| Knee flexors (left limb) Pre-test |
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| Knee flexors (left limb) Post-test |
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| Knee extensors (right limb) Pre-test |
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| Knee extensors (right limb) Post-test |
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| Knee extensors (left limb) Pre-test |
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| Knee extensors (left limb) Post-test |
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| Title | Measurements |
|---|---|
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| Session 4 |
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| Session 5 |
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| Session 6 |
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| Session 7 |
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