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Completed

NCT Number: NCT03704194

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

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.

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The Berg Balance Scale (BBS)

    Time frame: 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 outcomes

  1. The Self-Reported Habit Index (SRHI)

    Time frame: 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.

  2. The Activities-specific Balance Confidence Scale (ABC)

    Time frame: 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).

  3. The Short Physical Performance Battery (SPPB)

    Time frame: 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).

  4. Center of Pressure (CoP) Path (cm)

    Time frame: 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.

  5. Center of Pressure (CoP) Velocity (cm/s)

    Time frame: 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.

  6. Lower Extremity Muscle Strength

    Time frame: Baseline and 12 weeks

    Lower extremity muscle strength of hip and knee are measured by a dynamometer.

Other outcomes

  1. Recruitment and Retention Rate Are Documented by Therapist Logs

    Time frame: 16 weeks

    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.

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

    Time frame: 12 weeks

    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.

  3. Adherence Rate is Documented by LiFE Activity Calendar

    Time frame: 12 weeks

    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.

  4. Fidelity is Documented by a Visit-by-visit Checklist

    Time frame: 12 weeks

    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.

  5. Adverse Events

    Time frame: 16 weeks

    Safety of the program will be evaluated by the number of adverse events documented throughout the study duration.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Adapted Lifestyle-integrated Functional Exercise Program for Older Adults in Under Resourced Communities: A Pilot Study

Acronym: LiFE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 12, 2018
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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