Clinical trial NCT03704194: Adapted Lifestyle-integrated Functional Exercise Program for Medically Underserved Older Adults
Official title: Adapted Lifestyle-integrated Functional Exercise Program for Older Adults in Under Resourced Communities: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Fall
Keywords: falls
exercise program
medically underserved
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 17
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled feasibility trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Berg Balance Scale (BBS)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: The Self-Reported Habit Index (SRHI)
timeFrame: Baseline and 12 weeks
measure: The Activities-specific Balance Confidence Scale (ABC)
timeFrame: 12 weeks
measure: The Short Physical Performance Battery (SPPB)
timeFrame: Baseline and 12 weeks
measure: Center of Pressure (CoP) Path (cm)
timeFrame: Baseline and 12 weeks
measure: Center of Pressure (CoP) Velocity (cm/s)
timeFrame: Baseline and 12 weeks
measure: Lower Extremity Muscle Strength
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Recruitment and Retention Rate Are Documented by Therapist Logs
timeFrame: 16 weeks
measure: Acceptance of the Intervention Programs is Measured by a Question.
timeFrame: 12 weeks
measure: Adherence Rate is Documented by LiFE Activity Calendar
timeFrame: 12 weeks
measure: Fidelity is Documented by a Visit-by-visit Checklist
timeFrame: 12 weeks
measure: Adverse Events
timeFrame: 16 weeks
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Susan Stark, PhD
role: PRINCIPAL_INVESTIGATOR
References: