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Completed

NCT Number: NCT05697497

Functional Activity Strength Training

This study is a randomized trial of 100 older adults with mobility disability, who performed a similar brief daily, resistance training program. The investigators set out to answer the following question "Will a digital, brief daily exercise program be feasible, acceptable, and effective among older adults with walking limitations?" To answer that question, participants were assigned to an intervention or delayed-treatment control group. Intervention participants were assigned to complete two 30-second lower body exercises and two 30-second upper body exercises. Fitness tests were completed remotely three times during the 12-weeks (i.e., at baseline, week 6, week 12).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

This is a 12-week delayed-control randomized trial to answer the following question "Will a digital, brief daily exercise program be feasible, acceptable, and effective among older adults with walking limitations?" Participants who screen eligible will be assigned to one of four conditions, an immediate workout group, an immediate workout group with activity monitor, a delayed workout group or a delayed workout group with activity monitor. Participants will complete a daily 4-minute exercise routine at home and to record their results using an electronic survey. Other outcome measurements will be conducted remotely at baseline, 6, and 12 weeks.

The investigators hypothesize that participants in the AMRAP condition will report significant reductions in functional physical limitations, increased gait speed, and increased physical performance (i.e., increased exercise repetitions) from baseline to 6 weeks compared to those randomized to the delayed-treatment control.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 65 and older
  • Difficulty with walking
  • Providers must provide consent for their patient
  • Access to the internet
  • Must have a camera on computer, tablet, or smartphone
  • Fluent in Egnlish

Exclusion criteria

  • Chest pain or a heart condition on the PAR-Q
  • Planning to have surgery in the next 3 months
  • Cognitive impairment
  • Unable to exercise
  • Being currently physically active

Treatment and study plan

Daily exercise intervention

Behavioral

Participants will complete four exercises each day, The first two weeks they will be instructed to complete as many repetitions as possible, each day, for 15 seconds and progressing to 30 seconds per exercise after the first two weeks. Participants are asked to increase their goal repetitions by 1 or 2 from their previous best each week. For all exercises with modifications, we will encourage participants to move to the next most difficult modification once they can do 15 repetitions of that exercise.

Primary outcomes

  1. 30-Second Chair Stand

    Time frame: Baseline

    Leg strength and endurance test - number of chair stand repetitions in 30 seconds

  2. 30-Second Chair Stand

    Time frame: 6 weeks

    Leg strength and endurance test - number of chair stand repetitions in 30 seconds

  3. 30-Second Chair Stand

    Time frame: 12 weeks

    Leg strength and endurance test - number of chair stand repetitions in 30 seconds

  4. Five Time Sit to Stand Test (5TSTS)

    Time frame: Baseline

    The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.

  5. Five Time Sit to Stand Test (5TSTS)

    Time frame: 6 weeks

    The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.

  6. Five Time Sit to Stand Test (5TSTS)

    Time frame: 12 weeks

    The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.

  7. Single Leg Stance Test (SLS)

    Time frame: 12 weeks

    Assessment of static postural and balance control.

  8. Functional limitations

    Time frame: 12 weeks

    Physical Functioning Questionnaire from the National Health and Nutrition Examination Survey

  9. Falls

    Time frame: 12 weeks

    Falls over the past 3 months will be assessed using the Behavioral Risk Factor Surveillance System survey.

Secondary outcomes

  1. Walking gait cadence

    Time frame: 10 day period pre and post intervention

    Gait cadence will be measured in 50% of the participants using an activPAL device.

  2. Pain on the Patient Reported Outcomes Measurement Information System (PROMIS) survey

    Time frame: 12 weeks

    Survey using questions from the NIH-supported Patient Reported Outcomes Measurement Information System (PROMIS). The minimal value for pain interference is not at all, while the minimum value for pain intensity is no pain. The maximum value for pain interference is very much, while the maximum value for pain intensity is worst pain imaginable. A higher score generally means a worse outcome.

  3. Fatigue on the Patient Reported Outcomes Measurement Information System (PROMIS) survey

    Time frame: 12 weeks

    Survey using questions from the NIH-supported Patient Reported Outcomes Measurement Information System (PROMIS). The minimum value for fatigue is not at all, while the maximum value is very much. A higher score generally means a worse outcome.

  4. Self-Efficay for Physical Activity (SEPA)

    Time frame: 12 weeks

    5-item measure that assesses an individual's confidence for engaging in exercise in the presence of barriers.

  5. Percent of sessions attended

    Time frame: 12 weeks

    Patients will be considered adherent to the intervention when they enter their daily exercise performance data via daily survey. The percent of sessions attended will be calculated by dividing the number of sessions attended by the total number of sessions offered and multiplying the result by 100.

  6. Heart rate

    Time frame: 12 weeks

    resting and maximal heart rates will be collected during the maximal exercise performance tests

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

A Brief Digital Exercise Program to Improve Physical Function Among Older Adults

Acronym: FAST

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2023
Registry last updated
Jul 11, 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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