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

NCT ID: NCT03704194

Last Updated: 2025-08-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Accidental Fall

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled feasibility trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Adapted LiFE

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

Attention control

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Stark, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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201807067

Identifier Type: -

Identifier Source: org_study_id

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