NCT05725564

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
702

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2023Sep 2026

First Submitted

Initial submission to the registry

January 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 27, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

January 12, 2023

Last Update Submit

February 4, 2026

Conditions

Walking, DifficultyMobility Limitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Lower Extremity Performance

    12 Months

  • Dose Received

    Through study completion, an average of 1 year

  • Effort (Rating of Perceived Exertion)

    Monthly up to 12 months

  • Gait Speed (10 meter walk test)

    12 Months

  • Muscle Strength

    12 Months

  • +6 more secondary outcomes

Other Outcomes (4)

  • Body Weight (kg)

    12 Months

  • Height (cm)

    12 Months

  • Sociodemographics, self-reported medical history and tobacco use

    Baseline

  • +1 more other outcomes

Study Arms (4)

FAST-BCT

EXPERIMENTAL

FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching.

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.

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.

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.

Behavioral: Band TogetherBehavioral: Behavioral Change Technique

Interventions

FAST (Functional Activity Strength Training)BEHAVIORAL

Daily exercise intervention including functional resistance exercises and personalized coaching.

FAST+BCTFAST-BCT
Band TogetherBEHAVIORAL

3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes

BT+BCTBT-BCT
Behavioral Change TechniqueBEHAVIORAL

Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence

BT+BCTFAST+BCT

Eligibility Criteria

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

You may qualify if:

  • Age greater than or equal to 65
  • Self reported difficulty or inability to walk 1/4/ mile
  • Access to the Internet
  • Covid vaccination

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 13, 2023

Study Start

July 27, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(1)