Clinical trial NCT05697497: Functional Activity Strength Training
Official title: A Brief Digital Exercise Program to Improve Physical Function Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Walking, Difficulty
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 101
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 30-Second Chair Stand
timeFrame: Baseline
measure: 30-Second Chair Stand
timeFrame: 6 weeks
measure: 30-Second Chair Stand
timeFrame: 12 weeks
measure: Five Time Sit to Stand Test (5TSTS)
timeFrame: Baseline
measure: Five Time Sit to Stand Test (5TSTS)
timeFrame: 6 weeks
measure: Five Time Sit to Stand Test (5TSTS)
timeFrame: 12 weeks
measure: Single Leg Stance Test (SLS)
timeFrame: 12 weeks
measure: Functional limitations
timeFrame: 12 weeks
measure: Falls
timeFrame: 12 weeks
Secondary outcomes:
measure: Walking gait cadence
timeFrame: 10 day period pre and post intervention
measure: Pain on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
timeFrame: 12 weeks
measure: Fatigue on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
timeFrame: 12 weeks
measure: Self-Efficay for Physical Activity (SEPA)
timeFrame: 12 weeks
measure: Percent of sessions attended
timeFrame: 12 weeks
measure: Heart rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
References: