Recruiting

HIIT

Sponsor:

VA Office of Research and Development

Code:

NCT05625204

Conditions

Frailty

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Center based attention (stretching only) control

Center based HIIT

Home based HIIT

Study Details

Brief summary:

Frailty is defined as a greater susceptibility to stressors resulting from age-related impairments in adaptive biological systems. Frailty leads to poorer physical performance and functional capacity and higher risk of adverse outcomes including falls, hospitalization, and mortality. Resilience, defined as the capacity to recover from disruptions to homeostasis, is critical to successful aging because it precedes frailty and enhances adults' ability to maintain optimal health and function well into older age. Evidence- based therapies to help older adults enhance resilience are limited and the biological underpinnings contributing to improved resilience have not yet been fully characterized. To address this important need, the investigators will conduct a clinical trial to examine the benefits of center- and home-based high intensity interval training (HIIT) on functional capacity, frailty, and resilience, and also to identify novel biomarkers of resilience in older Veterans.

Conditions

Frailty

Study ID

NCT05625204

Start date

Jan 29, 2024

Status verified date

Dec, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ages 65 years and older
  • Male and female, any race
  • Medically cleared for exercise
  • Non-frail or pre-frail (frailty score < 3)
  • Ability to use a recumbent exercise bike

Exclusion Criteria:

  • Severe co-morbidity: COPD (GOLD stage IV), CKD ( stage 3)), severe HTN (180 mmHg/120 mmHg)
  • VA-SLUMS score 20 or lower (Cognition)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Center based attention control

Center based attention control

experimental: Center based HIIT

Center based HIIT

experimental: Home based HIIT

Home based HIIT

Interventions

Center based attention (stretching only) control

Center based attention (stretching only) control

Center based HIIT

Center based HIIT

Home based HIIT

Home based HIIT

Primary outcome measure

  • Sub-maximal oxygen uptake test (VO2max) [ Time Frame: Change from baseline to endpoint at 12 weeks ]

Central Contacts and Locations

Central contacts

Kenneth L Seldeen, PhD

(716) 888-4869Kenneth.Seldeen@va.gov

Bruce R Troen, MD

(816) 922-2755Bruce.Troen@va.gov

Locations

Kansas City VA Medical Center, Kansas City, MO

Recruiting

Kansas City, Missouri, United States, 64128-2226

Contacts

Ramratan R Sharma, PhD MHSA

(816) 922-2757ram.sharma2@va.gov

Principal Investigator:

Bruce R. Troen, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Keywords

  • aging
  • frailty
  • veteran
  • functional capacity
  • resilience
  • cognition
  • sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-12-12.