Adapted Lifestyle-integrated Functional Exercise Program for Medically Underserved Older Adults

Not Applicable

Completed

• Conditions: Accidental Fall
• Interventions: Behavioral: Adapted LiFE; Behavioral: Attention control

• Registration Number: NCT03704194
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Results First Submitted: 2020-05-18
• Results First Submitted QC: 2020-07-09
• Results First Posted: 2020-07-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapted LiFE	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.
Attention control	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
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.
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.
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.
Lower Extremity Muscle Strength	Baseline and 12 weeks	Lower extremity muscle strength of hip and knee are measured by a dynamometer.

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States