Mobility LimitationPhase 2/3FASTNIANCT06396247
Impact of Brief Daily Functional Resistance Training on Lower Extremity Physical Performance
A Phase 2/3 study testing Functional Activity Strength Training in people with Mobility Limitation, run by Milton S. Hershey Medical Center at 2 sites in United States.
Trial summary
In this study, we will randomly assign 360 older adults to 12 months of 5 minutes per day of functional resistance training or to a delayed treatment control condition, and measure the impact of the training on measures of lower extremity performance and walking ability. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Functional Activity Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2025to Sep 2028
- Phase
- Phase 2/3
- 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
- Self-reported difficulty or inability to walk ¼ mile
Who cannot join
- Chest pain on the PAR-Q
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Christopher N Sciamanna, MD, MPH, 610-585-9765, csciamanna@pennstatehealth.psu.edu
Jordan D Kurth, PhD, jkurth@pennstatehealth.psu.edu
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Bonny Rockette-Wagner, PhD, 412-624-0188, bjr26@pitt.edu
Bonny Rockette-Wagner, PhD
About this study
In this study, we will randomly assign 360 older adults to 12 months of 5 minutes per day of functional resistance training or to a delayed treatment control condition, and measure the impact of the training on measures of lower extremity performance and walking ability.
Read the detailed description
One of the most common, and untreated, health problems among older adults is mobility disability, observed in nearly one in five (17.9%) of older adults. Mobility disability is typically the first disability to develop and increases future risk for additional disabilities and death. Though the most effective treatments for mobility disability are forms of exercise, especially resistance training (RT), they are rarely used, with fewer than 20% of older adults meeting RT guidelines and even fewer among those with mobility disability. The core problem of disseminating the benefits of RT to older adults is adherence. One potential opportunity to enhance adherence to RT, which has not been tested, is to make RT programs shorter. Studies show that most of the benefits of RT accrue with the first few sets per week, consistent with the law of diminishing utility. While traditional RT programs for older adults, like those offered by Silver Sneakers, are typically 45 minutes three times weekly, fewer than 5% of older adults with free access to these programs participate. Our qualitative work shows that older adults often feel that 45 minute sessions are too challenging (e.g., "I don't think I have the strength to do it for 45 minutes") and 75% of older adults we surveyed preferred a 5 minute RT to a 45 minute RT option, assuming they were equally effective. In 2020, we set out to design a brief, home-based RT program that would lead to both high levels of adherence and functional improvement. We called the program FAST (Functional Activity Strength Training) and, to overcome its brevity, FAST was augmented with several standard behavior change techniques (e.g., feedback, reminders, self-monitoring) and a novel form of goal- setting, rarely used in RT studies, for the number of additional repetitions participants should be able to do during the study. In FAST-1, 24 healthy older adults were prescribed 30 seconds of squats and push-ups each day and given no personal supervision. Over 6 months, they performed the exercises on 73% of days and showed large increases in squat and push-up performance (Cohen's d > 1.0). In FAST-2, we randomly assigned 97 older adults with mobility disability, and those assigned to 30 seconds each of chair stands and steps onto a stepper each day completed exercises on 81% of days (5.7 days per week) and improved their 5 time sit-to-stand test (-2.8 seconds, Cohen's d=0.53), 30 second chair stand test (+4.2 repetitions, d=1.1) and One Leg Stand test (+3.7 seconds, d=0.40), versus controls. In this multicenter study, we will randomly assign 360 older adults with an SPPB score < 8 to 6 months of daily FAST or to a delayed control group. We will test the impact of FAST on physical performance, walking ability, falls and functional limitations. We hypothesize that FAST will improve these measures more than controls, and that those with greater adherence and perceived effort will improve the most. By rigorously testing FAST, we hope to change the paradigm of RT prescription from "More is better" to "What will people do that works?" and, if FAST proves superior, a future study will test whether FAST leads more older adults to do RT and, thereby, improve the public's health.
- Conditions
- Mobility Limitation
- Being tested
- Functional Activity Strength Training
- Keywords
- older adults, walking, mobility
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Activity Strength TrainingBehavioural
FAST consists of five exercises (stepping on a step, chair stands, push-ups, rows, walking), for 30 seconds each, performed daily, with 30 seconds of rest between.
| Study group | Role | What they receive |
|---|---|---|
| Functional Activity Strength TRaining | Experimental | Participants will perform 5 minutes of functional resistance training daily, supported by 24 video coaching sessions over 12 months. Receives: Behavioral: Functional Activity Strength Training |
| Delayed Treatment | Active comparator | Participants will receive the intervention after 12 months. Receives: Behavioral: Functional Activity Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
The SPPB assesses balance, gait speed, and lower extremity strength.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start9 Apr 2025
- Primary completionJan 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We hypothesize that patients assigned to FAST will improve these outcomes significantly more than those assigned to DTC and that FAST participants with higher levels of perceived exertion and adherence will improve these measures the most.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Penn State Health Milton S Hershey Medical Center
- Investigators
- Maggie Nellissery, Ph.D., Study chair, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396247
- Sponsor's protocol ID
- STUDY00024492
- Other IDs
- R01AG079938
- Acronym
- FASTNIA
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We estimate the upload at 10MB, as we have experience uploading our data into ICPSR
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Brief Daily Functional Resistance Training on Lower Extremity Physical Performance
- ClinicalTrials.gov ID
- NCT06396247
- Acronym / sponsor ID
- FASTNIA / STUDY00024492
- Conditions
- Mobility Limitation
- Keywords
- older adults, walking, mobility
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 May 2024 (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 study, we will randomly assign 360 older adults to 12 months of 5 minutes per day of functional resistance training or to a delayed treatment control condition, and measure the impact of the training on measures of lower extremity performance and walking ability.
Detailed description
One of the most common, and untreated, health problems among older adults is mobility disability, observed in nearly one in five (17.9%) of older adults. Mobility disability is typically the first disability to develop and increases future risk for additional disabilities and death. Though the most effective treatments for mobility disability are forms of exercise, especially resistance training (RT), they are rarely used, with fewer than 20% of older adults meeting RT guidelines and even fewer among those with mobility disability. The core problem of disseminating the benefits of RT to older adults is adherence. One potential opportunity to enhance adherence to RT, which has not been tested, is to make RT programs shorter. Studies show that most of the benefits of RT accrue with the first few sets per week, consistent with the law of diminishing utility. While traditional RT programs for older adults, like those offered by Silver Sneakers, are typically 45 minutes three times weekly, fewer than 5% of older adults with free access to these programs participate. Our qualitative work shows that older adults often feel that 45 minute sessions are too challenging (e.g., "I don't think I have the strength to do it for 45 minutes") and 75% of older adults we surveyed preferred a 5 minute RT to a 45 minute RT option, assuming they were equally effective. In 2020, we set out to design a brief, home-based RT program that would lead to both high levels of adherence and functional improvement. We called the program FAST (Functional Activity Strength Training) and, to overcome its brevity, FAST was augmented with several standard behavior change techniques (e.g., feedback, reminders, self-monitoring) and a novel form of goal- setting, rarely used in RT studies, for the number of additional repetitions participants should be able to do during the study. In FAST-1, 24 healthy older adults were prescribed 30 seconds of squats and push-ups each day and given no personal supervision. Over 6 months, they performed the exercises on 73% of days and showed large increases in squat and push-up performance (Cohen's d > 1.0). In FAST-2, we randomly assigned 97 older adults with mobility disability, and those assigned to 30 seconds each of chair stands and steps onto a stepper each day completed exercises on 81% of days (5.7 days per week) and improved their 5 time sit-to-stand test (-2.8 seconds, Cohen's d=0.53), 30 second chair stand test (+4.2 repetitions, d=1.1) and One Leg Stand test (+3.7 seconds, d=0.40), versus controls. In this multicenter study, we will randomly assign 360 older adults with an SPPB score < 8 to 6 months of daily FAST or to a delayed control group. We will test the impact of FAST on physical performance, walking ability, falls and functional limitations. We hypothesize that FAST will improve these measures more than controls, and that those with greater adherence and perceived effort will improve the most. By rigorously testing FAST, we hope to change the paradigm of RT prescription from "More is better" to "What will people do that works?" and, if FAST proves superior, a future study will test whether FAST leads more older adults to do RT and, thereby, improve the public's health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- We hypothesize that patients assigned to FAST will improve these outcomes significantly more than those assigned to DTC and that FAST participants with higher levels of perceived exertion and adherence will improve these measures the most.
| Arm | Type | Receives |
|---|---|---|
| Functional Activity Strength TRaining | Experimental | Behavioral: Functional Activity Strength TrainingParticipants will perform 5 minutes of functional resistance training daily, supported by 24 video coaching sessions over 12 months. |
| Delayed Treatment | Active comparator | Behavioral: Functional Activity Strength TrainingParticipants will receive the intervention after 12 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Self-reported difficulty or inability to walk ¼ mile
Key exclusion criteria (1 listed)
- Chest pain on the PAR-Q
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 |
|---|---|---|
| Functional Activity Strength TrainingFAST consists of five exercises (stepping on a step, chair stands, push-ups, rows, walking), for 30 seconds each, performed daily, with 30 seconds of rest between. | Behavioural | Delayed Treatment, Functional Activity Strength TRaining |
Primary outcome
Short Physical Performance Battery
Time frame: Baseline, 6 months, 12 months
The SPPB assesses balance, gait speed, and lower extremity strength.
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 22 Jul 2026.
- Individual participant dataSharing planned: Yes. We estimate the upload at 10MB, as we have experience uploading our data into ICPSR
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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.
Maggie Nellissery, Ph.D. study chair
National Institute on Aging (NIA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Functional Activity Strength Training in people with Mobility Limitation, run by Milton S. Hershey Medical Center at 2 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Christopher Sciamanna, MD, MPH (610-585-9765, cns10@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.