NCT06396247

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
28mo left

Started Apr 2025

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Apr 2025Sep 2028

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

April 9, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

April 29, 2024

Last Update Submit

July 11, 2025

Conditions

Keywords

older adultswalkingmobility

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery

    The SPPB assesses balance, gait speed, and lower extremity strength.

    Baseline, 6 months, 12 months

Study Arms (2)

Functional Activity Strength TRaining

EXPERIMENTAL

Participants will perform 5 minutes of functional resistance training daily, supported by 24 video coaching sessions over 12 months.

Behavioral: Functional Activity Strength Training

Delayed Treatment

ACTIVE COMPARATOR

Participants will receive the intervention after 12 months.

Behavioral: Functional Activity Strength Training

Interventions

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.

Delayed TreatmentFunctional Activity Strength TRaining

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Self-reported difficulty or inability to walk ¼ mile

You may not qualify if:

  • Chest pain on the PAR-Q

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maggie Nellissery, Ph.D.

    National Institute on Aging (NIA)

    STUDY CHAIR

Central Study Contacts

Christopher Sciamanna, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

April 9, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

We estimate the upload at 10MB, as we have experience uploading our data into ICPSR

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
12 months after study has completed
Access Criteria
ICPSR Account holder
More information

Locations