Clinical trial NCT05725564: Testing Interventions for Mobility Through Exercise (TIME)
Official title: PCORI-HA-2021C3-25041 Comparative Effectiveness of Brief Strength and Balance Exercises and Standard Home-Based Group Exercise for Primary Care Patients With Mobility Disability
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Walking, Difficulty
Mobility Limitation
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 620
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, to a program for home (BAND TOGETHER) that is similar to one offered by Silver Sneakers, available online to millions of older adults, and includes strength, balance, and aerobic exercises. The team hypothesizes that the brief program (FAST) will improve leg function better than the standard program (BAND TOGETHER), by encouraging older adults to be more consistent with using it and to try harder when they do.

Detailed description: One in four older adults, the fastest growing demographic group in the US, reports serious difficulty walking or climbing stairs. Older adults note that these walking difficulties "deprives you of your identity" and "affects my day to day life... I can't do very much work on my own." Walking difficulties impair people's quality of life more than depression, anxiety, or pain. Walking difficulties also increase the chances of future disability, death, and healthcare costs. Though strength training improves walking ability, fewer than one in five older adults do strength training enough to benefit. What is unknown is how to create a strength training program that improves the ability of older adults to walk and do other things they need and want to do and that older adults are willing to do.

One approach to designing a strength training program that has not been tried before is to make them shorter. In 2020, the project team set out to design a short strength training program that older adults could do at home that would improve their physical function and that they would consistently do. The program was called FAST (Functional Activity Strength Training) and, to make it more effective, the team set specific goals for how many additional repetitions each person should be able to do over 12 weeks. These goals were then mentioned repeatedly, and feedback was provided about how well people made progress toward these goals.

In the first study of FAST (FAST-1), 24 healthy older adults performed 30 seconds of squats and push-ups each day but received no personal supervision. Over six months, they performed the exercises on 73 percent of days, which led to large increases in the number of push-ups and squats they were able to do. In the second study of FAST (FAST-2), the team randomly assigned 97 older adults who had trouble walking, and those assigned to do 30 seconds each of chair stands and steps onto a stepper each day improved their ability to stand up from a chair and stand on one leg more than those who did not do the exercises.

In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, to a program for home (BAND TOGETHER) that is similar to one offered by Silver Sneakers, available online to millions of older adults, and includes strength, balance, and aerobic exercises. The team hypothesizes that the brief program (FAST) will improve leg function better than the standard program (BAND TOGETHER), by encouraging older adults to be more consistent with using it and to try harder when they do.

This study will enroll 520 primary care patients who are at least 65 years of age and randomly assign them to have access to 12 months of daily FAST or three-times weekly BAND TOGETHER. Each program will be delivered via the internet and each patient will receive about 30 minutes per month of personal support. The study will enroll patients who have trouble walking, have access to the internet, can provide informed consent, and receive permission from their doctor. The study is designed to see whether patients who have access to FAST, after 12 months, have better walking ability, balance, and leg strength and can do their normal daily activities more easily and fall less often than patients who have access to BAND TOGETHER.

To help us understand how best to perform the study, as well as how best to share the results, the study team assembled a group of stakeholders that includes patients, primary care providers, fitness center directors, and people who work for insurance, public health, and senior services organizations. The team will bring those stakeholders together each year and consult them regularly to help make difficult decisions as they arise-decisions that may impact each group of stakeholders differently. Two patient partners will work with investigators to supervise the group of stakeholders and organize their feedback, structured as a public comment period, to help the research team make decisions that take into account the perspectives of all of the key groups of stakeholders involved in improving the physical function of older adults.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 65
* Self reported difficulty or inability to walk 1/4/ mile
* Access to the Internet
* Covid vaccination

Exclusion Criteria:

* Chest pain on the PAR-Q
* Participating in another research project involving physical activity, falls or weight loss
* Planning to move or have surgery in the next 12 months
* Cognitive impairment

Primary outcomes:
measure: Physical Function
timeFrame: 12 Months
Secondary outcomes:
measure: Lower Extremity Performance
timeFrame: 12 Months
measure: Dose Received
timeFrame: Through study completion, an average of 1 year
measure: Effort (Rating of Perceived Exertion)
timeFrame: Monthly up to 12 months
measure: Gait Speed (10 meter walk test)
timeFrame: 12 Months
measure: Muscle Strength
timeFrame: 12 Months
measure: Walking Ability
timeFrame: 12 Months
measure: Fatigue, Pain
timeFrame: 12 Months
measure: Falls
timeFrame: 12 Months
measure: Physical Activity
timeFrame: 12 months
measure: Number of participants with a self-reported injury due to physical activities
timeFrame: Monthly up to 12 months
measure: Program Satisfaction
timeFrame: Monthly up to 12 months
Other outcomes:
measure: Body Weight (kg)
timeFrame: 12 Months
measure: Height (cm)
timeFrame: 12 Months
measure: Sociodemographics, self-reported medical history and tobacco use
timeFrame: Baseline
measure: Caregiving Status Questions (Receiving and Providing)
timeFrame: Monthly up to 12 months
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
References: