FrailtyHIIT-VANCT03750006

Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training

A study testing Short session HIIT in people with Frailty, run by VA Office of Research and Development at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Frailty
What is being tested?: Short session HIIT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 3 Dec 2018to 31 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female
Any race
Frail, pre-frail, and non-frail
Medical clearance for exercise

Who cannot join

Severe co-morbidity (e.g. - CHF (class III), COPD (GOLD stage IV), CKD (stage 3))
VAMC SLUMS score 20
Physical impairment that prevents use of a recumbent exercise bike

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215

Other trials in United States

About this study

Frailty is a clinical condition of poor physiological reserve that increases risks for adverse health outcomes including falls, hospitalization and mortality. Exercise is beneficial for the prevention and even reversal of frailty, yet participation among older individuals is limited. Short session high intensity interval training (HIIT) is emerging as a promising exercise strategy that achieves performance gains with lower time commitment. The goal of this pilot proposal is to establish the feasibility of HIIT exercise training protocols in 65-85 year old individuals, as well as to demonstrate the ability to detect functional and physiologic benefits. The investigators anticipate the preliminary research findings will lay the foundation for future human clinical studies that will permit us to significantly improve the health of Veterans.

Read the detailed description

Enhancing functional capacity in older adults with short session high intensity interval training

Frailty is a condition of poor physiological reserve that increases susceptibility to falls, hospitalization, disability and mortality. The incidence of frailty rapidly increases after the age 65, growing from 10% to as many as 50% of those 85 years or older; therefore over 9 million Veterans are either frail or at risk for frailty. Exercise has proven benefits for frailty, yet older adults rarely attain the recommended 150 minutes a week of moderate intensity exercise. High intensity interval training (HIIT) is emerging as an alternative as it delivers similar or better gains than moderate intensity exercise in less time. Recently, the investigators published that a 3-day-a-week, 10-minute HIIT regimen in aged mice not only reduces frailty, but leads to both strength and endurance benefits. In addition, the preliminary data demonstrate significant changes in microRNA (miRNA) profiles. Despite the potential of short session HIIT to improve functional capacity and lead to better adherence, the modality has not been tested in individuals 65-85 years of age, and in particular, frail individuals. The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.

To accomplish these goals the investigators will administer a short session HIIT regimen totaling only 10-minutes, 3-days-a-week for 3 months, using recumbent exercise cycles, to 65-85 year old participants. The investigators will also utilize next generation RNA sequence technology to assess HIIT impacts upon microRNA profiles in serum samples. The investigators anticipate this project will demonstrate the feasibility of administering short session HIIT to older individuals, including vulnerable frail and pre-frail populations as well as demonstrate the ability to collect and analyze serum miRNA profiles. The advantages to this program are the ability to maintain or build muscle mass and improve aerobic conditioning, especially in older patients where frailty and sarcopenia are so prevalent. This pilot project will therefore lay the foundation for future clinical trials that further explore the utility of HIIT to prevent or delay the onset of frailty in larger cohorts, and ultimately lead to the enhancement of functional capacity and quality of life in aging Veteran populations.

Conditions: Frailty
Being tested: Short session HIIT
Keywords: frailty, sarcopenia, exercise, high intensity, older adults, microRNA
Medical subject headings: Frailty, Sarcopenia, Motor Activity

What participants receive

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

Short session HIITBehavioural
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.

Study groups in NCT03750006
Study group	Role	What they receive
HIIT intervention	Experimental	Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Receives: Behavioral: Short session HIIT

What is being measured

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

6-minute Walk at Baseline and Endpoint
6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace.
Measured: baseline and at participant completion, an average of 3 months
Physical Activity Enjoyment at Baseline and Endpoint
Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 questions, each of which can receive a score from 1 to 7, where 7 is represents greater enjoyment. Scores presented as the mean across all questions giving an overall range of 1-7.
Measured: baseline and at participant completion, an average of 3 months
VO2max at Baseline and Endpoint
Performed as part of a symptom limited maximal endurance test on a cycle ergometer
Measured: baseline and at participant completion, an average of 3 months

Secondary outcomes (13)

Short Physical Performance Battery at Baseline and Endpoint
Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, including balance, side-by-side/semi-tandem/tandem stands, and gait speed. There are 3 subscales, each of which can receive from 0 to 4 points. Therefore the total range of the test spans summed scores from 0 to 12, where 12 is the best outcome.
Measured: baseline and at participant completion, an average of 3 months
Frailty at Baseline and Endpoint
Fried frailty phenotype assessment includes: gait speed, grip strength, endurance, activity level, weight loss.
These assessments report summed scores of 0 to 5, where 0 is the best outcome. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) for the age and gender adjusted range, then it is given a score of "1". If both questions on the endurance or activity measures are positive then then it is given a score of "1". If weight loss is greater than 5% over the past year, then it is given a score of "1".
Measured: baseline and at participant completion, an average of 3 months
Quality of Life Survey at Baseline and Endpoint
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5, where 5 is the better outcome. Therefore the total range of the test spans scores from 14 to 70, where 70 is the best outcome. The final score as a percentage with range being 0-100% and top being 100%. This percentage is calculated as: 100 * ((participant's score - 14) / 56).
Measured: baseline and at participant completion, an average of 3 months
Cognitive Survey at Baseline and Endpoint
VA-SLUMS: VA Saint Louis University Mental Status screen. Survey includes 11 questions allowing a range of scores from 1-30 points, where higher scores represent greater mental outcomes.
Measured: baseline and at participant completion, an average of 3 months
Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint
The Activities of Daily living and instrumental activities of daily living are a survey comprised of 14 questions including ability to: dress, eat, ambulate, toilet, hygiene, shop, housework, accounting, food preparation, and use transportation/telephone. Each question gives up to 1 point with a total range of 0-14. Higher scores indicate less independence and greater reliance on support.
Measured: baseline and at participant completion, an average of 3 months
microRNA Profiling at Baseline and Endpoint
Next Generation Sequencing of microRNA species from serum.
Measured: baseline and at participant completion, an average of 3 months
Serum 25-hydroxy-vitamin D at Baseline
serum 25-hydroxy-vitamin D was measured from serum isolated from blood collected at baseline and measured using ELISA
Measured: baseline
C-reactive Protein Level at Baseline and Endpoint
C-reactive protein was measured from isolated serum samples at baseline and endpoint using ELISA
Measured: baseline and at participant completion, an average of 3 months
Quadriceps Strength at Baseline and Endpoint
Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in kilograms (kg) of force.
Measured: baseline and at participant completion, an average of 3 months
FRAIL Scale Survey at Baseline and Endpoint
FRAIL scale: fatigability, resistance, ambulation, illnesses, loss of weight. If the answers to any of the questions is yes, then given score is "1" with a total survey range of 0 to 5. Higher scores represent greater frailty.
Measured: baseline and at participant completion, an average of 3 months
Serum Interleukin-6 Level at Baseline and Endpoint
Interleukin-6 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA
Measured: baseline and at participant completion, an average of 3 months
Serum Interleukin-10 Level at Baseline and Endpoint
Interleukin-10 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA
Measured: baseline and at participant completion, an average of 3 months
Number of Participants With Muscle Tissue Oxygenation Raw Data Collected
Seeking to collect raw data using functional near infra-red spectroscopy to analyze quadriceps during VO2max test. This work is the first steps in the development of techniques that analyze muscle blood flow and tissue oxygenation during exercise.
Measured: baseline and at participant completion, an average of 3 months

Timeline

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

3 Dec 201831 Dec 2022

First posted21 Nov 2018
Study start3 Dec 2018
Primary completion31 Dec 2021
Study completion31 Dec 2022

Why it stopped: COVID pandemic halted ability to enroll participants. Grant funded then ended.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FrailtyStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Model description: The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03750006
Sponsor's protocol ID: E2902-P
Other IDs: RX002902
Acronym: HIIT-VA
Status last verified: Aug 2024
First submitted: 9 Nov 2018
Last updated: 30 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Thus, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; (c) restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource, and (d) a commitment to destroying or returning the data after analyses are completed. De identified data will be maintained on a VA server and will only be shared via encrypted devices. Co-Investigators will have access to the data collected as part of their aims. Investigators working on the grant will have access to the data through the PI. The data will be monitored routinely to maintain safety and productivity, as well as to assist with research dissemination annually.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Frailty trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training
ClinicalTrials.gov ID: NCT03750006
Acronym / sponsor ID: HIIT-VA / E2902-P
Conditions: Frailty
Keywords: frailty, sarcopenia, exercise, high intensity, older adults, microRNA
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID pandemic halted ability to enroll participants. Grant funded then ended.
Enrolment: 42 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: The VA Western New York Healthcare System, University at Buffalo, Roswell Park Cancer Institute
Study start: 3 Dec 2018 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 21 Nov 2018 (actual)
Results: Posted 30 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Enhancing functional capacity in older adults with short session high intensity interval training

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.

Arm	Type	Receives
HIIT intervention	Experimental	Behavioral: Short session HIITIndividually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female
Any race
Frail, pre-frail, and non-frail
Medical clearance for exercise

Key exclusion criteria (3 listed)

Severe co-morbidity (e.g. - CHF (class III), COPD (GOLD stage IV), CKD (stage 3))
VAMC SLUMS score 20
Physical impairment that prevents use of a recumbent exercise bike

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Short session HIITIndividually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.	Behavioural	HIIT intervention

Primary outcome

6-minute Walk at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace.
Physical Activity Enjoyment at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 questions, each of which can receive a score from 1 to 7, where 7 is represents greater enjoyment. Scores presented as the mean across all questions giving an overall range of 1-7.
VO2max at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Performed as part of a symptom limited maximal endurance test on a cycle ergometer

13 secondary outcomes

Short Physical Performance Battery at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Frailty at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Quality of Life Survey at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Cognitive Survey at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
microRNA Profiling at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Serum 25-hydroxy-vitamin D at Baseline
Time frame: baseline
C-reactive Protein Level at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Quadriceps Strength at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
FRAIL Scale Survey at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Serum Interleukin-6 Level at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Serum Interleukin-10 Level at Baseline and Endpoint
Time frame: baseline and at participant completion, an average of 3 months
Number of Participants With Muscle Tissue Oxygenation Raw Data Collected
Time frame: baseline and at participant completion, an average of 3 months

Results and safety

Results posted to the registry on 30 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIIT Intervention	42	23

Primary outcome: 6-minute Walk at Baseline and Endpoint

Time frame: baseline and at participant completion, an average of 3 months. Mean (Standard Deviation). Unit: meters

Measure	HIIT Intervention n = 23
Baseline	418.2 (72.2)
Endpoint	436.8 (55.6)

HIIT Intervention: p = 0.0238, t-test, 2 sided

Primary outcome: Physical Activity Enjoyment at Baseline and Endpoint

Time frame: baseline and at participant completion, an average of 3 months. Mean (Standard Deviation). Unit: Scores on a scale

Measure	HIIT Intervention n = 22
Baseline	6.1 (0.8)
Endpoint	6.2 (0.8)

HIIT Intervention: p = 0.3029, t-test, 2 sided

Population analysed: One participant was not able to complete the assessment due to scheduling conflict.

Primary outcome: VO2max at Baseline and Endpoint

Time frame: baseline and at participant completion, an average of 3 months. Mean (Standard Deviation). Unit: mL/min/kg

Measure	HIIT Intervention n = 14
Baseline	18.67 (5.12)
Endpoint	19.93 (5.59)

HIIT Intervention: p = 0.1713, t-test, 2 sided

Population analysed: 8 participants were not able to complete the VO2max end point assessment due to COVID pandemic study cessation. One participant was not able to complete the assessment due to scheduling conflict.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected weekly over a 14 week period for each participant, commencing from baseline assessments week 0, through the HIIT intervention (weeks 1 - 12 or up to 14), and ending with collection at end-point assessments.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIIT Intervention	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Limitations and caveats (from the sponsor): Goal of trial was to evaluate recruitment, administration, and safety profile of short session HIIT, and not necessarily the efficacy of the HIIT protocol for functional capacity. Trial does not have a non-exercise control group Trial features limited number of participants (23), which includes only 1 female Trial was stopped short due to COVID-19 pandemic, 8 of the 23 participants did not complete the total 12 weeks of training although all participants had at least 6 weeks of training.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Thus, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (a) a commitment to using the data only for research purposes and not to identify any individual participant; (b) a commitment to securing the data using appropriate computer technology; (c) restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource, and (d) a commitment to destroying or returning the data after analyses are completed. De identified data will be maintained on a VA server and will only be shared via encrypted devices. Co-Investigators will have access to the data collected as part of their aims. Investigators working on the grant will have access to the data through the PI. The data will be monitored routinely to maintain safety and productivity, as well as to assist with research dissemination annually.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce R. Troen, MD principal investigator

VA Western New York Healthcare System, Buffalo, NY

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Short session HIIT in people with Frailty, run by VA Office of Research and Development at 1 site 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 30 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute Walk at Baseline and Endpoint (time frame: baseline and at participant completion, an average of 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03750006.

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 30 Aug 2024.