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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Christopher Sciamanna, MD, MPH contact

610-585-9765

cns10@psu.edu

Jordan Kurth, Ph.SD. contact

815-988-6357

jkurth@pennstatehealth.psu.edu

United States2 sites, 2 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

    Recruiting

Other trials in United States

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.

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 groups in NCT06396247
Study groupRoleWhat they receive
Functional Activity Strength TRainingExperimentalParticipants 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 TreatmentActive comparatorParticipants 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.

  1. 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.

  1. First posted2 May 2024
  2. Study start9 Apr 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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)
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

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.

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