Functional Activity Strength Training

Walking, Difficulty Clinical Trial

— FAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05697497
• Other study ID #: STUDY00016054
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: January 6, 2022

Study information

• Verified date: August 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 6, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation
• Walking, Difficulty

Intervention

Behavioral:
• Daily exercise intervention
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.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-Second Chair Stand	Leg strength and endurance test - number of chair stand repetitions in 30 seconds	Baseline
Primary	30-Second Chair Stand	Leg strength and endurance test - number of chair stand repetitions in 30 seconds	6 weeks
Primary	30-Second Chair Stand	Leg strength and endurance test - number of chair stand repetitions in 30 seconds	12 weeks
Primary	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.	Baseline
Primary	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.	6 weeks
Primary	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.	12 weeks
Primary	Single Leg Stance Test (SLS)	Assessment of static postural and balance control.	12 weeks
Primary	Functional limitations	Physical Functioning Questionnaire from the National Health and Nutrition Examination Survey	12 weeks
Primary	Falls	Falls over the past 3 months will be assessed using the Behavioral Risk Factor Surveillance System survey.	12 weeks
Secondary	Walking gait cadence	Gait cadence will be measured in 50% of the participants using an activPAL device.	10 day period pre and post intervention
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	Self-Efficay for Physical Activity (SEPA)	5-item measure that assesses an individual's confidence for engaging in exercise in the presence of barriers.	12 weeks
Secondary	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.	12 weeks
Secondary	Heart rate	resting and maximal heart rates will be collected during the maximal exercise performance tests	12 weeks