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FrailtyHIIT@HomeNCT05625204

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

A study testing Center based HIIT and Home based HIIT in people with Frailty, run by VA Office of Research and Development at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Frailty
What is being tested?
Center based HIIT and Home based HIIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesUnited States
Study dates
29 Jan 2024to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kenneth L Seldeen, PhD contact

(716) 888-4869

Kenneth.Seldeen@va.gov

Bruce R Troen, MD contact

(816) 922-2755

Bruce.Troen@va.gov

United States2 sites, 2 recruiting
  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128-2226

    Ramratan R Sharma, PhD MHSA, (816) 922-2757, ram.sharma2@va.gov

    Bruce R. Troen, MD

    Recruiting
  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128

    Bruce R Troen, MD, bruce.troen@va.gov

    Kenneth L Seldeen, PhD, Kenneth.seldeen@va.gov

    Not yet recruiting

Other trials in United States

About this study

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.

Read the detailed description

Impact of Home-Based High Intensity Interval Training on Resilience in Older Veterans More than 30% of U.S. Veterans 65 years or older are frail, which is three-times higher than in non-Veterans in the same age group. Frailty is defined as an increased susceptibility to stressors resulting from age-related impairments in adaptive biological systems, leading to higher risk of adverse outcomes including falls, disability, hospitalization, and mortality. Further, frailty prevalence increases with age, affecting 50% of all adults 85 and over. Resilience, which is defined as the capacity to recover from stress-induced disruptions to homeostasis, is critical to successful aging because it precedes frailty and presents an opportunity to intervene on early health deficits, thus preventing aging-related decline in health, function, and quality of life. Evidence-based therapies that enhance resilience in older adults are limited and the complex biological and physiological mechanisms underlying resilience are not yet fully understood. Consequently, Veterans seeking to boost their ability to recover from late-life stressors and prevent frailty have few proven options. The investigators overarching aim is to characterize the complex factors contributing to resilience and develop novel strategies that enhance resilience to boost health span in older adults. Towards this end, the investigators previous VA RR\&D SPiRE Award allowed us to demonstrate the feasibility of 12-weeks of high intensity interval training (HIIT) among older Veterans. The investigators successfully enrolled and retained older male and female Veterans and safely conducted individually tailored HIIT that improved cardiorespiratory fitness, lower-body endurance, cognition, and quality of life. The purpose of the proposed larger trial is to build upon the investigators previous successes and develop and implement practical HIIT regimens to reduce frailty and enhance resilience in older Veterans. The investigators will conduct a randomized controlled trial to ascertain the therapeutic benefits of 12-weeks of center- and home-based HIIT on recovery and resilience among Veterans 60 years or older. The investigators have identified a series of biomarkers of resilience and are also seeking to examine key biological drivers of recovery at the molecular level. The investigators proposed study will not only identify feasible methods to measure resilience in older Veterans but will also assess the benefits of home-based HIIT on physical and cognitive performance, frailty, resilience, and health span.

Conditions
Frailty
Being tested
Center based attention (stretching only) control, Center based HIIT, Home based HIIT
Keywords
aging, frailty, veteran, functional capacity, resilience, cognition, sleep
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Center based attention (stretching only) controlBehavioural

    Center based attention (stretching only) control

  • Center based HIITBehavioural

    Center based HIIT

  • Home based HIITBehavioural

    Home based HIIT

Study groups in NCT05625204
Study groupRoleWhat they receive
Center based attention controlExperimentalCenter based attention control
Receives: Behavioral: Center based attention (stretching only) control
Center based HIITExperimentalCenter based HIIT
Receives: Behavioral: Center based HIIT
Home based HIITExperimentalHome based HIIT
Receives: Behavioral: Home based HIIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from baseline to endpoint at 12 weeks

Secondary outcomes (27)
  1. Cognitive screen - SLUMS

    Cognitive status will be assessed using the VA - St. Louis University Mental Survey (VA-SLUMS) involving memory tests, shape recognition, and story recall. The survey scores range from 0-30, with a higher score representing greater cognitive capability. The investigators will also utilize the Cognivue to assess cognition. This is a combinatorial visual and reaction time test.

    Measured: Change from baseline to endpoint at 12 weeks

  2. Amyloid beta 42/40 ratio

    Serum cognitive marker: change in amyloid beta 42/40 ratio (a unitless measure derived from the ratio of serum amyloid-beta 42 in picograms per milliliter divided by serum amyloid-beta 40 in picograms per milliliter) from baseline to endpoint after 12 weeks.

    Measured: Change from baseline to endpoint at 12 weeks

  3. Cognitive screen - Cognivue

    Cognivue to assess cognition. This is a computer based combinatorial visual and reaction time test, which is scored 0 to 100.

    Measured: Change from baseline to endpoint at 12 weeks

  4. Phosphorylated tau (P-tau)

    Serum cognitive marker: plasma levels of phosphorylated tau (P-tau) in picograms per milliliter from baseline to endpoint after 12 weeks.

    Measured: Change from baseline to endpoint at 12 weeks

  5. Brain Derived Neurotrophic Factor (BDNF)

    Serum cognitive marker: change in Brain Derived Neurotrophic Factor (BDNF) in picograms per milliliter from baseline to endpoint after 12 weeks.

    Measured: Change from baseline to endpoint at 12 weeks

  6. Fatigue

    Fatigue as assessed by the Brief Fatigue Inventory, which contains 9 self-rated questions with an aggregate score range of 0 to 90.

    Measured: Change from baseline to endpoint at 12 weeks

  7. Sleep quantity and stages

    Objectively measure sleep quantity and stages using FITBIT Charge 5 actigraphy devices. These devices are worn on the wrist and sleep metrics, including total sleep time and time spent in light, deep, and REM sleep stages.

    Measured: Change from baseline to endpoint at 12 weeks

  8. Sleep quality

    Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-rated questions that combined to form 7 component scores, each with a range of 0 to 3 points. These in turn are added to yield a global score with a range of 0 to 21 points.

    Measured: Change from baseline to endpoint at 12 weeks

  9. Sleep chronotype

    Sleep chronotype as assessed by the Morningness/Eveningness survey, which contains 19 self-rated questions with an aggregate score range of 19 to 72.

    Measured: Change from baseline to endpoint at 12 weeks

  10. Sleepiness

    Sleepiness as assessed by the Epworth Sleepiness Scale, which contains 8 self-rated questions with an aggregate score range of 0 to 24.

    Measured: Change from baseline to endpoint at 12 weeks

  11. Insomnia

    Insomnia as assessed by the Insomnia Severity Index, which contains 7 self-rated questions with an aggregate score range of 0 to 28.

    Measured: Change from baseline to endpoint at 12 weeks

  12. Anxiety and depression

    Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS), which contains 14 self-rated questions with an aggregate score range of 0 to 21.

    Measured: Change from baseline to endpoint at 12 weeks

  13. Sleep disorders

    Sleep disorders as assessed by the Holland Sleep Disorders Questionnaire, which contains 32 self-rated questions with an aggregate score range of 32 and 160.

    Measured: Change from baseline to endpoint at 12 weeks

  14. 30 second chair rise test

    The investigators will measure endurance in participants by asking participants to sit and rise repeated from a chair as many times in a 30 second time frame.

    Measured: Change from baseline to endpoint at 12 weeks

  15. Frailty assessment

    Frailty is a syndrome marked by greater susceptibility to adverse outcomes like falls and disability. The investigators will be using the Fried Frailty Phenotype that includes: 1) unexpected weight loss of 5% or more in the last year or BMI < 18.5; score 0 or 1 if positive, 2) grip strength with BMI dependent cut points for men and women; score 0 or 1 if positive, 3) gait speed with height and sex dependent cutoffs; score 0 or 1 if positive, 4) activity assessed by a survey of the frequency of mild/moderate/energetic physical activity; score of 0 or 1, the latter if positive for hardly ever or never engaging in moderate or energetic physical activity, and 5) endurance assessed by survey of bed rest during the day; score of 0 or 1, the latter if occurring every day or every week. The composite score is therefore 0 to 5.

    Measured: Change from baseline to endpoint at 12 weeks

  16. Gait speed

    Participants are asked to perform a timed walk of approximately 15 feet in length

    Measured: Change from baseline to endpoint at 12 weeks

  17. Arm curl endurance

    Participants will receive a free weight (8lbs for men and 5lbs for women) and asked to perform total number of arm curls in 30 seconds while in a seated position.

    Measured: Change from baseline to endpoint at 12 weeks

  18. Quality of life assessment

    Quality of life assessment is performed using the Quality of life, enjoyment, and satisfaction questionnaire - short form (Q-LES-Q-SF) survey instrument. The survey instrument scores from 0 to 70 with a greater score representing better quality of life.

    Measured: Change from baseline to endpoint at 12 weeks

  19. Body Composition (Lean and fat mass)

    Body composition will be measured using bioelectric impedance (BIA) - a technique where participants are asked to stand on the measurement device and hold on to two metal handles. A light - and non-detectable - current is then transmitted allowing for collection of body fat and lean mass in the subject. The assessment takes roughly 2-3 minutes.

    Measured: Change from baseline to endpoint at 12 weeks

  20. Step counts

    Objectively measure activity using FITBIT Charge 5 actigraphy devices. These devices are worn on the wrist and capture total steps.

    Measured: Change from baseline to endpoint at 12 weeks

  21. C-Reactive Protein

    Chronic inflammation may be indicative of distress and lead to chronic diseases. The study will examine the change in C-reactive protein in picograms per milliliter in serum from baseline to endpoint at 12 weeks.

    Measured: Change from baseline to endpoint at 12 weeks

  22. Interleukin-6

    Chronic inflammation may be indicative of distress and lead to chronic diseases. The study will examine the change in interleukin-6 in picograms per milliliter in serum from baseline to endpoint at 12 weeks.

    Measured: Change from baseline to endpoint at 12 weeks

  23. Interleukin-10

    Chronic inflammation may be indicative of distress and lead to chronic diseases. The study will examine the change in interleukin-10 in picograms per milliliter in serum from baseline to endpoint at 12 weeks.

    Measured: Change from baseline to endpoint at 12 weeks

  24. Eforto Grip endurance

    participants will be ask to perform a grip endurance assessment using an Eforto device. The device has a squeezable ball that measures force through changes in air pressure in response to squeezing. Participants are asked to attempt three maximal force tests at 5 seconds each, and then asked to maintain maximal grip for as long as they are able to hold.

    Measured: Change from baseline to endpoint at 12 weeks

  25. Biosway balance assessment

    Participants are measured for microsway (mm/s) while standing on a Biosway balance device. Participants will be asked to hold balance for 45 seconds while standing comfortably, standing with eyes close, standing with a narrow stance, and standing with a narrow stance with eyes closed.

    Measured: Change from baseline to endpoint at 12 weeks

  26. Resilience to Blood occlusion

    Participants will be asked to wear a blood pressure cuff while a functional near infrared spectroscopy device measures flow flow in the lower arm. The cuff will be applied to restrict blood flow for 2 minutes, and then released to observe blood oxygenation recovery in the lower arm.

    Measured: Change from baseline to endpoint at 12 weeks

  27. Stroop Color and Word Test

    Participants will be asked to perform the Stroop color and word test. This test features three sections in which the participant will first read words written in black, then part two name the color of blocks, then the final part name the color of the written words.

    Measured: Change from baseline to endpoint at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2022
  2. Study start29 Jan 2024
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05625204
Sponsor's protocol ID
E3813-R
Other IDs
RX003813-01A2
Acronym
HIIT@Home
Status last verified
Dec 2025
First submitted
14 Nov 2022
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.

Questions about this trial

What is this clinical trial studying?

A study testing Center based HIIT and Home based HIIT in people with Frailty, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kenneth L Seldeen, PhD ((716) 888-4869, Kenneth.Seldeen@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sub-maximal oxygen uptake test (VO2max) (time frame: Change from baseline to endpoint at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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