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Functional Activity Strength Training (FAST)

Primary Purpose

Walking, Difficulty

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily exercise intervention
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Walking, Difficulty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Immediate start group with gait cadence assessment

Immediate start group without gait cadence assessment

Delayed-treatment control group with gait cadence assessment

Delayed-treatment control group without gait cadence assessment

Arm Description

This group will wear an activPAL device for 10 days prior to their baseline assessment and for 10 days after their week 12 assessment. The exercise intervention consists of a 2.5 to 3.5 minute daily routine that includes 2 upper body and 2 lower body exercises.

The exercise intervention consists of a 2.5 to 3.5 minute daily routine that includes 2 upper body and 2 lower body exercises.

This group will wear an activPAL device for 10 days prior to their baseline assessment and for 10 days after their week 12 assessment. The exercise intervention consists of a 2.5 to 3.5 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.

The exercise intervention consists of a 2.5 to 3.5 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.

Outcomes

Primary Outcome Measures

30-Second Chair Stand
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
30-Second Chair Stand
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
30-Second Chair Stand
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
Five Time Sit to Stand Test (5TSTS)
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.
Five Time Sit to Stand Test (5TSTS)
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.
Five Time Sit to Stand Test (5TSTS)
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.
Single Leg Stance Test (SLS)
Assessment of static postural and balance control.
Functional limitations
Physical Functioning Questionnaire from the National Health and Nutrition Examination Survey
Falls
Falls over the past 3 months will be assessed using the Behavioral Risk Factor Surveillance System survey.

Secondary Outcome Measures

Walking gait cadence
Gait cadence will be measured in 50% of the participants using an activPAL device.
Pain on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
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.
Fatigue on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
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.
Self-Efficay for Physical Activity (SEPA)
5-item measure that assesses an individual's confidence for engaging in exercise in the presence of barriers.
Percent of sessions attended
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.
Heart rate
resting and maximal heart rates will be collected during the maximal exercise performance tests

Full Information

First Posted
February 8, 2022
Last Updated
August 16, 2023
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05697497
Brief Title
Functional Activity Strength Training
Acronym
FAST
Official Title
A Brief Digital Exercise Program to Improve Physical Function Among Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
January 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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 2.5-to-3.5-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Walking, Difficulty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A delayed treatment control group will be used to compare the effects of the intervention to a control group. Both groups will complete their study visits at baseline, week 6, and week 12, with the intervention group starting their exercises immediately after the baseline visit and the delayed treatment control group starting their exercise intervention after their week 12 visit.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate start group with gait cadence assessment
Arm Type
Experimental
Arm Description
This group will wear an activPAL device for 10 days prior to their baseline assessment and for 10 days after their week 12 assessment. The exercise intervention consists of a 2.5 to 3.5 minute daily routine that includes 2 upper body and 2 lower body exercises.
Arm Title
Immediate start group without gait cadence assessment
Arm Type
Experimental
Arm Description
The exercise intervention consists of a 2.5 to 3.5 minute daily routine that includes 2 upper body and 2 lower body exercises.
Arm Title
Delayed-treatment control group with gait cadence assessment
Arm Type
No Intervention
Arm Description
This group will wear an activPAL device for 10 days prior to their baseline assessment and for 10 days after their week 12 assessment. The exercise intervention consists of a 2.5 to 3.5 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.
Arm Title
Delayed-treatment control group without gait cadence assessment
Arm Type
No Intervention
Arm Description
The exercise intervention consists of a 2.5 to 3.5 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.
Intervention Type
Behavioral
Intervention Name(s)
Daily exercise intervention
Intervention Description
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 Outcome Measure Information:
Title
30-Second Chair Stand
Description
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
Time Frame
Baseline
Title
30-Second Chair Stand
Description
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
Time Frame
6 weeks
Title
30-Second Chair Stand
Description
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
Time Frame
12 weeks
Title
Five Time Sit to Stand Test (5TSTS)
Description
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.
Time Frame
Baseline
Title
Five Time Sit to Stand Test (5TSTS)
Description
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.
Time Frame
6 weeks
Title
Five Time Sit to Stand Test (5TSTS)
Description
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.
Time Frame
12 weeks
Title
Single Leg Stance Test (SLS)
Description
Assessment of static postural and balance control.
Time Frame
12 weeks
Title
Functional limitations
Description
Physical Functioning Questionnaire from the National Health and Nutrition Examination Survey
Time Frame
12 weeks
Title
Falls
Description
Falls over the past 3 months will be assessed using the Behavioral Risk Factor Surveillance System survey.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Walking gait cadence
Description
Gait cadence will be measured in 50% of the participants using an activPAL device.
Time Frame
10 day period pre and post intervention
Title
Pain on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
Description
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.
Time Frame
12 weeks
Title
Fatigue on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
Description
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.
Time Frame
12 weeks
Title
Self-Efficay for Physical Activity (SEPA)
Description
5-item measure that assesses an individual's confidence for engaging in exercise in the presence of barriers.
Time Frame
12 weeks
Title
Percent of sessions attended
Description
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.
Time Frame
12 weeks
Title
Heart rate
Description
resting and maximal heart rates will be collected during the maximal exercise performance tests
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Functional Activity Strength Training

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