Testing Interventions for Mobility Through Exercise (TIME) (TIME)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mobility Limitation; Walking, Difficulty
• Intervention / Treatment: Behavioral: FAST (Functional Activity Strength Training); Behavioral: Behavioral Change Technique; Behavioral: Band Together

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.

• Study Type: Interventional
• Enrollment (Actual): 702
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAST-BCT; FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching.	Behavioral: FAST (Functional Activity Strength Training); Daily exercise intervention including functional resistance exercises and personalized coaching.
Experimental: FAST+BCT; FAST exercise intervention with behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort.	Behavioral: FAST (Functional Activity Strength Training); Daily exercise intervention including functional resistance exercises and personalized coaching.; Behavioral: Behavioral Change Technique; Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence
Active Comparator: BT-BCT; Band Together exercise intervention without behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes.	Behavioral: Band Together; 3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes
Active Comparator: BT+BCT; Band Together exercise intervention with behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort.	Behavioral: Behavioral Change Technique; Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence; Behavioral: Band Together; 3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	Patient-Reported Outcomes Measurement Scale (PROMIS-29). The minimum and maximum values are unable to do and without any difficulty, and a higher score means a better outcome.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower Extremity Performance	Short Physical Performance Battery. The minimum value is a score of 0 points, the maximum value is a score of 16. A higher score means a better outcome.	12 Months
Dose Received	Sessions completed per week (percent)	Through study completion, an average of 1 year
Effort (Rating of Perceived Exertion)	Rating of Perceived Exertion. The minimum value is 0 (at rest) and the maximum value is 10 (maximal). This is a purely subjective measure here a higher or lower score doesn't necessarily lead to a better outcome, but for our exercise study we have a target RPE of 5 for exercise.	Monthly up to 12 months
Gait Speed (10 meter walk test)	Gait Speed (10 meter walk test). Participants undergo two trials (comfortable speed and fast speed), and an average of the two trials is used as the gait speed in m/s.	12 Months
Muscle Strength	Upper and lower extremity strength	12 Months
Walking Ability	6 Minute Walk Distance	12 Months
Fatigue, Pain	Patient Reported Outcomes Measurement Scale (PROMIS-29). The minimum value for the fatigue scales is "not at all", the maximum value is "very much". A lower score means a better outcome. The minimum values for the pain scales are "not at all" and 0, the maximum values "very much" and 10. A lower value means a better outcome.	12 Months
Falls	Percent experiencing a fall-related injury	12 Months
Physical Activity	Accelerometry over 7 days	12 months
Number of participants with a self-reported injury due to physical activities	Injuries due to physical activities	Monthly up to 12 months
Program Satisfaction	Net Promoter Score. The maximum value is 10 and the minimum value is 0. A higher value means a better outcome.	Monthly up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight (kg)	Body Weight (kg)	12 Months
Height (cm)	Height (cm)	12 Months
Sociodemographics, self-reported medical history and tobacco use	Age, gender, race and ethnicity, medical history, smoking status, and education	Baseline
Caregiving Status Questions (Receiving and Providing)	Giving and receiving caregiving, paid or unpaid, for personal care needs, such as eating, bathing, dressing, or getting around inside the home.	Monthly up to 12 months

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mobility Limitation
• Other Study ID Numbers: HA-2021C3-25041; PCORI-HA-2021C3-25041 (Other Identifier: PCORI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No