Walking, DifficultyTIMENCT05725564
Testing Interventions for Mobility Through Exercise (TIME)
A study testing FAST (Functional Activity Strength Training), Band Together and Behavioral Change Technique in people with Walking, Difficulty and Mobility Limitation, run by Milton S. Hershey Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Walking, Difficulty, Mobility Limitation
- What is being tested?
- FAST (Functional Activity Strength Training), Band Together and Behavioral Change Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 702 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age greater than or equal to 65
- Self reported difficulty or inability to walk 1/4/ mile
- Access to the Internet
- Covid vaccination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
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
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.
Read the 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.
- Conditions
- Walking, Difficulty, Mobility Limitation
- Being tested
- FAST (Functional Activity Strength Training), Band Together, Behavioral Change Technique
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAST (Functional Activity Strength Training)Behavioural
Daily exercise intervention including functional resistance exercises and personalized coaching.
Band TogetherBehavioural
3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes
Behavioral Change TechniqueBehavioural
Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence
| Study group | Role | What they receive |
|---|---|---|
| FAST-BCT | Experimental | FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching. Receives: Behavioral: FAST (Functional Activity Strength Training) |
| FAST+BCT | Experimental | 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. Receives: Behavioral: FAST (Functional Activity Strength Training); Behavioral: Behavioral Change Technique |
| BT-BCT | Active comparator | 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. Receives: Behavioral: Band Together |
| BT+BCT | Active comparator | 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. Receives: Behavioral: Band Together; Behavioral: Behavioral Change Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (11)
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.
Measured: 12 Months
Dose Received
Sessions completed per week (percent)
Measured: 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.
Measured: 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.
Measured: 12 Months
Muscle Strength
Upper and lower extremity strength
Measured: 12 Months
Walking Ability
6 Minute Walk Distance
Measured: 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.
Measured: 12 Months
Falls
Percent experiencing a fall-related injury
Measured: 12 Months
Physical Activity
Accelerometry over 7 days
Measured: 12 months
Number of participants with a self-reported injury due to physical activities
Injuries due to physical activities
Measured: 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.
Measured: Monthly up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start27 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Walking, DifficultyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725564
- Sponsor's protocol ID
- HA-2021C3-25041
- Other IDs
- PCORI-HA-2021C3-25041
- Acronym
- TIME
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sciamanna CN, Kurth JD, Luzier W, Conroy DE, Calo WA, Schmitz K, Silvis ML, Ballentine NH, Zhou S, Danilovich M, Rovniak LS, Moeller M, Pierwola-Gawin N, Kraschnewski JL, Poger J, Herrell C. Testing Interventions for Mobility through Exercise (TIME): Study protocol for a randomized trial comparing a novel, brief home-based exercise program and a standard home-based group exercise for older adults with mobility disability. Contemp Clin Trials. 2024 Dec;147:107709. doi: 10.1016/j.cct.2024.107709. Epub 2024 Oct 9.
PubMed 39384065
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05725564
- Acronym / sponsor ID
- TIME / HA-2021C3-25041
- Conditions
- Walking, Difficulty, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FAST-BCT | Experimental | Behavioral: FAST (Functional Activity Strength Training)FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching. |
| FAST+BCT | Experimental | Behavioral: FAST (Functional Activity Strength Training), Behavioral: Behavioral Change TechniqueFAST 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. |
| BT-BCT | Active comparator | Behavioral: Band TogetherBand 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. |
| BT+BCT | Active comparator | Behavioral: Band Together, Behavioral: Behavioral Change TechniqueBand 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 65
- Self reported difficulty or inability to walk 1/4/ mile
- Access to the Internet
- Covid vaccination
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAST (Functional Activity Strength Training)Daily exercise intervention including functional resistance exercises and personalized coaching. | Behavioural | FAST+BCT, FAST-BCT |
| Band Together3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes | Behavioural | BT+BCT, BT-BCT |
| Behavioral Change TechniqueReminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence | Behavioural | BT+BCT, FAST+BCT |
Primary outcome
Physical Function
Time frame: 12 Months
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.
11 secondary outcomes
Lower Extremity Performance
Time frame: 12 Months
Dose Received
Time frame: Through study completion, an average of 1 year
Effort (Rating of Perceived Exertion)
Time frame: Monthly up to 12 months
Gait Speed (10 meter walk test)
Time frame: 12 Months
Muscle Strength
Time frame: 12 Months
Walking Ability
Time frame: 12 Months
Fatigue, Pain
Time frame: 12 Months
Falls
Time frame: 12 Months
Physical Activity
Time frame: 12 months
Number of participants with a self-reported injury due to physical activities
Time frame: Monthly up to 12 months
Program Satisfaction
Time frame: Monthly up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 39384065Sciamanna CN, Kurth JD, Luzier W, Conroy DE, Calo WA, Schmitz K, Silvis ML, Ballentine NH, Zhou S, Danilovich M, Rovniak LS, Moeller M, Pierwola-Gawin N, Kraschnewski JL, Poger J, Herrell C. Testing Interventions for Mobility through Exercise (TIME): Study protocol for a randomized trial comparing a novel, brief home-based exercise program and a standard home-based group exercise for older adults with mobility disability. Contemp Clin Trials. 2024 Dec;147:107709. doi: 10.1016/j.cct.2024.107709. Epub 2024 Oct 9.
Related trials for Walking, Difficulty
Active, not recruiting
Randomized Clinical Trial to Improve Mobility After Hospitalization
Hypertension, Diabetes
Not yet recruiting
Impact of Loss Aversion Messaging and Anticipated Regret for Inaction on Exercise Adherence in Older Adults
Mobility Disability, Walking Difficulty
RecruitingPhase 2
Response to Exercise and Nitric Oxide in PAD
Peripheral Artery Disease, Exercise
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Active, not recruiting
Far Red Light to Improve Functioning in PAD
Peripheral Artery Disease, Peripheral Vascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAST (Functional Activity Strength Training), Band Together and Behavioral Change Technique in people with Walking, Difficulty and Mobility Limitation, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05725564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.