What side effects are associated with this type of intervention?

High Intensity Interval Training (HIIT) for frailty can significantly improve physical performance and functional capacity, enhancing resilience. However, potential side effects include musculoskeletal injuries, cardiovascular strain, and overtraining, particularly in frail individuals. Proper monitoring and gradual progression are crucial to minimize these risks. Resistance training, another common treatment, may cause muscle soreness, joint pain, and injury if not adequately supervised.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned in the provided context for the treatment of frailty. However, High Intensity Interval Training (HIIT) is highlighted as a promising non-pharmacological intervention to improve physical performance, functional capacity, and resilience in older adults. HIIT has shown benefits in increasing muscle strength, endurance, and reducing frailty scores, making it a valuable approach for managing frailty.

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HIIT for Reducing Frailty in Older Veterans (HIIT@Home Trial)

Q: What other types of research exist?

Promising alternatives to High Intensity Interval Training (HIIT) for frailty patients include Moderate Intensity Continuous Training (MICT) and Resistance Training (RT). MICT can improve functional exercise capacity and quality of life, while RT can enhance muscle strength and physical performance. Both approaches are effective and may be more suitable for some patients due to their lower intensity and different focus.

N/A

Recruiting

Led By Bruce R. Troen, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to endpoint at 12 weeks

Awards & highlights

Summary

This trial tests if short, intense exercises with rest periods can help older Veterans stay healthier and more active. The goal is to see if this method can reduce frailty and improve their ability to recover from stress.

Who is the study for?

This trial is for older veterans, both male and female of any race, who are at least 60 years old. Participants should be non-frail or pre-frail with a frailty score less than 3 and must be medically cleared to exercise. Those with severe COPD, advanced kidney disease, extreme high blood pressure, or significant cognitive impairment cannot join.

What is being tested?

The study is testing the effects of different types of High Intensity Interval Training (HIIT) on reducing frailty and enhancing resilience in older adults. It compares center-based HIIT, home-based HIIT against a control group receiving standard attention without intensive training.

What are the potential side effects?

While specific side effects are not listed for this type of physical intervention, general risks may include muscle soreness, fatigue after workouts, increased risk of falls during exercise sessions and potential exacerbation of underlying health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to endpoint at 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to endpoint at 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to endpoint at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Composition (Lean and fat mass)

C-Reactive Protein

Frailty assessment

+8 more

Secondary study objectives

Amyloid beta 42/40 ratio

Anxiety and depression

Brain Derived Neurotrophic Factor (BDNF)

+10 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Home based HIITExperimental Treatment1 Intervention

Home based HIIT

Group II: Center based attention controlExperimental Treatment1 Intervention

Center based attention control

Group III: Center based HIITExperimental Treatment1 Intervention

Center based HIIT

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

High Intensity Interval Training (HIIT) improves frailty by enhancing muscle strength, endurance, and mitochondrial function, while reducing inflammation. These mechanisms are crucial for frailty patients as they lead to better physical performance and functional capacity, allowing for improved recovery from stressors. This enhanced resilience helps maintain optimal health and reduces the risk of adverse outcomes such as falls, hospitalization, and mortality.

High Intensity Interval Training Improves Physical Performance and Frailty in Aged Mice.Are the group-based interventions improving the functional exercise capacity and quality of life of frail subjects with chronic heart failure?Short Session High Intensity Interval Training and Treadmill Assessment in Aged Mice.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,647 Previous Clinical Trials

3,359,870 Total Patients Enrolled

10 Trials studying Frailty

40,663 Patients Enrolled for Frailty

Bruce R. Troen, MDPrincipal InvestigatorKansas City VA Medical Center, Kansas City, MO

2 Previous Clinical Trials

77 Total Patients Enrolled

2 Trials studying Frailty

77 Patients Enrolled for Frailty

Media Library

Center based HIIT Clinical Trial Eligibility Overview. Trial Name: NCT05625204 — N/A

Frailty Research Study Groups: Center based attention control, Center based HIIT, Home based HIIT

Frailty Clinical Trial 2023: Center based HIIT Highlights & Side Effects. Trial Name: NCT05625204 — N/A

Center based HIIT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625204 — N/A

~133 spots leftby Dec 2027

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