- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05697497
Functional Activity Strength Training (FAST)
A Brief Digital Exercise Program to Improve Physical Function Among Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Condition
The exercise intervention consists of a 4 minute daily routine that includes 2 upper body and 2 lower body exercises.
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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.
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No Intervention: Delayed-Treatment Control Group
The exercise intervention consists of a 4 minute daily routine that includes 2 upper body and 2 lower body exercises.
Participants in the this arm will not start the exercise intervention until the day after the week 12 assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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30-Second Chair Stand
Time Frame: Baseline
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Leg strength and endurance test - number of chair stand repetitions in 30 seconds
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Baseline
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30-Second Chair Stand
Time Frame: 6 weeks
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Leg strength and endurance test - number of chair stand repetitions in 30 seconds
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6 weeks
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30-Second Chair Stand
Time Frame: 12 weeks
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Leg strength and endurance test - number of chair stand repetitions in 30 seconds
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12 weeks
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Five Time Sit to Stand Test (5TSTS)
Time Frame: Baseline
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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.
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Baseline
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Five Time Sit to Stand Test (5TSTS)
Time Frame: 6 weeks
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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.
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6 weeks
|
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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.
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12 weeks
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Single Leg Stance Test (SLS)
Time Frame: 12 weeks
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Assessment of static postural and balance control.
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12 weeks
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Functional limitations
Time Frame: 12 weeks
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Physical Functioning Questionnaire from the National Health and Nutrition Examination Survey
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12 weeks
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Falls
Time Frame: 12 weeks
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Falls over the past 3 months will be assessed using the Behavioral Risk Factor Surveillance System survey.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking gait cadence
Time Frame: 10 day period pre and post intervention
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Gait cadence will be measured in 50% of the participants using an activPAL device.
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10 day period pre and post intervention
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Pain on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
Time Frame: 12 weeks
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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.
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12 weeks
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Fatigue on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
Time Frame: 12 weeks
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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.
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12 weeks
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Self-Efficay for Physical Activity (SEPA)
Time Frame: 12 weeks
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5-item measure that assesses an individual's confidence for engaging in exercise in the presence of barriers.
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12 weeks
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Percent of sessions attended
Time Frame: 12 weeks
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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.
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12 weeks
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Heart rate
Time Frame: 12 weeks
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resting and maximal heart rates will be collected during the maximal exercise performance tests
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12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00016054
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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