High Intensity Interval Training (HIIT) to Reduce Frailty and Enhance Resilience in Older Veterans

NCT05625204 | Recruiting DMC

• 2 other identifiers: E3813-RRX003813-01A2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sub-maximal oxygen uptake test (VO2max)

  Participants are asked to exercise on an upright exercise bike as the resistance increases over time. During the exercise, participants are asked to breath through a mask that is connected to a oxygen and carbon dioxide measuring device. The assessment last for approximately 5-10 minutes and provides data the pertain to an individuals lung capacity, breathing rate, and endurance.

  Change from baseline to endpoint at 12 weeks

Secondary Outcomes (27)

• Cognitive screen - SLUMS

  Change from baseline to endpoint at 12 weeks

• Amyloid beta 42/40 ratio

  Change from baseline to endpoint at 12 weeks

• Cognitive screen - Cognivue

  Change from baseline to endpoint at 12 weeks

• Phosphorylated tau (P-tau)

  Change from baseline to endpoint at 12 weeks

• Brain Derived Neurotrophic Factor (BDNF)

  Change from baseline to endpoint at 12 weeks

Study Arms (3)

Center based attention control

EXPERIMENTAL

Center based attention control

Behavioral: Center based attention (stretching only) control

Center based HIIT

EXPERIMENTAL

Center based HIIT

Behavioral: Center based HIIT

Home based HIIT

EXPERIMENTAL

Home based HIIT

Behavioral: Home based HIIT

Interventions

Center based HIIT BEHAVIORAL

Center based HIIT

Center based HIIT

Home based HIIT BEHAVIORAL

Home based HIIT

Home based HIIT

Center based attention (stretching only) control BEHAVIORAL

Center based attention (stretching only) control

Center based attention control

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: 157 male and 43 female participants divided equally between non-frail and pre-frail individuals, based upon Fried frailty criteria.
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, 64128-2226, United States

RECRUITING

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, 64128, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruce R. Troen, MD

  Kansas City VA Medical Center, Kansas City, MO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth L Seldeen, PhD

CONTACT

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

Bruce R Troen, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: January 29, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After analysis and completion of study along with subsequent publication of results.
• Access Criteria: After analysis and completion of study along with subsequent publication of results.

Locations

US (2)