NCT07210645

Brief Summary

The overall purpose of this study is to develop a power training intervention in partnership with Veterans participating in Gerofit and to evaluate the program's acceptability, feasibility, and preliminary participant outcomes (leg power, physical function and self-report participation).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
57mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress2%
Apr 2026Dec 2030

First Submitted

Initial submission to the registry

September 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

April 6, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

September 29, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

power trainingmobilityolder adultuser-centered design

Outcome Measures

Primary Outcomes (1)

  • Adherence

    Adherence will be measured as a proportion of the number of sessions attended out of the number prescribed per protocol.

    assessed at 3-months (primary endpoint) and 6 months in both intervention and standard of care groups

Secondary Outcomes (11)

  • Retention

    assessed at 3-months (primary) and 6 months

  • Feasibility

    assessed at 3-months (primary) and 6 months

  • Acceptability

    assessed at 3-months (primary) and 6 months

  • Leg Press Power

    baseline, 3-months and 6 months

  • 4 stair climb power test (4SCPT)

    baseline, 3-months and 6 months

  • +6 more secondary outcomes

Study Arms (2)

Gerofit Power Training Intervention

EXPERIMENTAL

This group will be randomized to receive Gerofit power training intervention for 6 months. They will receive power training as part of each Gerofit exercise session. Gerofit exercise sessions also include aerobic, flexibility, and balance training.

Other: Gerofit Power Training

Gerofit Standard of Care

ACTIVE COMPARATOR

This group will be randomized to receive standard of care exercise Gerofit exercise prescription for 6 months. Standard of care exercise for the Gerofit program includes combined aerobic, strength, flexibility and balance training.

Other: Gerofit Standard of Care

Interventions

Gerofit Power Training will include a power training exercise prescription which will focus on having participants perform concentric portions of each resistance exercise as fast and as safely as possible with the eccentric component performed in a slow and controlled manner. The target dose of the power training intervention is 40-60% of the participant's 1-repetition maximum for 4-6 repetitions across 3-6 sets for each exercise. Exercises will focus on the major groups of the upper and lower body. All other Gerofit program components (balance, aerobic, and flexibility) will be consistent with the standard of care group. Sessions will be the same duration as the standard of care Gerofit group (60-75 minutes). The power training and standard of care groups will only differ in the form of resistance training performed.

Gerofit Power Training Intervention

Gerofit standard of care is a 60-75 minute multimodal exercise program which includes 20-30 minutes of aerobic training, traditional strength training of the major upper and lower body muscle groups (1-3 sets of 8-12 repetitions at moderate load), flexibility training and balance training.

Gerofit Standard of Care

Eligibility Criteria

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

You may qualify if:

  • Pilot Study Criteria:
  • Veterans 65 years of age and older
  • New enrollees of the Rocky Mountain Regional Gerofit Program
  • ability to function independently in a group setting

You may not qualify if:

  • inability to perform basic activities of daily living
  • oxygen dependency
  • unstable cardiac disease
  • moderate to severe cognitive impairment (Montreal cognitive assessment scores \< 24)
  • proliferative diabetic retinopathy
  • inability to ambulate
  • progressive neurological diagnoses (e.g. Amyotrophic lateral sclerosis, Parkinson's disease, multiple sclerosis)
  • individuals with planned orthopedic surgeries in the next 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

Study Officials

  • Mattie E Pontiff, PT, DPT, PhD

    Rocky Mountain Regional VA Medical Center, Aurora, CO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattie E Pontiff, PT, DPT, PhD

CONTACT

Jennifer E Stevens-Lapsley, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to 1 of 2 groups: Group 1 (Gerofit power training) will receive the intervention for 6 months, and Group 2 (Gerofit standard of care) will receive standard of care for 6 months.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 7, 2025

Study Start

April 6, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations