Testing Interventions for Mobility Through Exercise (TIME)

Mobility Limitation Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725564
• Other study ID #: HA-2021C3-25041
• Secondary ID: PCORI-HA-2021C3-
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2023
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: Milton S. Hershey Medical Center
• Contact: Chris Sciamanna, MD
• Phone: 610 585 9765
• Email: csciamanna[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 620
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation
• Walking, Difficulty

Intervention

Behavioral:
• FAST (Functional Activity Strength Training)
Daily exercise intervention including functional resistance exercises and personalized coaching.
• Band Together
3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes
• Behavioral Change Technique
Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence

Locations

Country	Name	City	State
United States	Penn State College of Medicine	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
Other	Body Weight (kg)	Body Weight (kg)	12 Months
Other	Height (cm)	Height (cm)	12 Months
Other	Sociodemographics, self-reported medical history and tobacco use	Age, gender, race and ethnicity, medical history, smoking status, and education	Baseline
Other	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
Primary	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	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
Secondary	Dose Received	Sessions completed per week (percent)	Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	Muscle Strength	Upper and lower extremity strength	12 Months
Secondary	Walking Ability	6 Minute Walk Distance	12 Months
Secondary	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
Secondary	Falls	Percent experiencing a fall-related injury	12 Months
Secondary	Physical Activity	Accelerometry over 7 days	12 months
Secondary	Number of participants with a self-reported injury due to physical activities	Injuries due to physical activities	Monthly up to 12 months
Secondary	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