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

NCT03704194 | Completed Results

• 1 other identifier: 201807067
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Fall

Keywords

falls; exercise program; medically underserved

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• The Self-Reported Habit Index (SRHI)

  Baseline and 12 weeks

• The Activities-specific Balance Confidence Scale (ABC)

  12 weeks

• The Short Physical Performance Battery (SPPB)

  Baseline and 12 weeks

• Center of Pressure (CoP) Path (cm)

  Baseline and 12 weeks

• Center of Pressure (CoP) Velocity (cm/s)

  Baseline and 12 weeks

Other Outcomes (5)

• Recruitment and Retention Rate Are Documented by Therapist Logs

  16 weeks

• Acceptance of the Intervention Programs is Measured by a Question.

  12 weeks

• Adherence Rate is Documented by LiFE Activity Calendar

  12 weeks

Study Arms (2)

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.

Behavioral: Adapted LiFE

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.

Behavioral: Attention control

Interventions

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.

Adapted LiFE

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.

Attention control

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Results Point of Contact

• Title: Brittany Minor
• Organization: Washington university in St.louis

bminor@wustl.edu

314-273-4118

Study Officials

• Susan Stark, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled feasibility trial

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 12, 2018
• Study Start: August 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: August 27, 2025
• Results First Posted: July 28, 2020

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)