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Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training (HIIT-VA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03750006
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
VA Western New York Healthcare System
University at Buffalo
Roswell Park Cancer Institute
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Frailty Behavioral: Short session HIIT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training
Actual Study Start Date : December 3, 2018
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: HIIT intervention
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Behavioral: Short session HIIT
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.




Primary Outcome Measures :
  1. Change from baseline VO2 Max at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    VO2 max, also known as maximal oxygen uptake, will be assessed.

  2. Change from baseline in physical activity enjoyment at 3 months [ 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 subscales, each of which can receive a score from 1 to 7. Therefore the total range of the test spans summed scores from 18 to 126.


Secondary Outcome Measures :
  1. Change from baseline in the SPPB at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    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 up to 4 points. Therefore the total range of the test spans summed scores from 1 to 12.

  2. Change from baseline in frailty phenotype at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]

    Fried frailty phenotype assessment including: gait speed, grip strength, endurance, activity level, weight loss.

    These scales report summed scores of 0 to 5. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) fof 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".


  3. Change from baseline in Quality of Life at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5. Therefore the total range of the test spans scores from 14 to 70.

  4. Change from baseline in cognition at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    VA-SLUMS: VA Saint Louis University Mental Status screen.

  5. Change from baseline in Activities of Daily Living & Instrumental Activities of Daily Living at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    ADLs: dressing, eating, ambulation, toileting, and hygiene IADLs: shopping, housework, accounting, food preparation, transportation/telephone

  6. Change from baseline in microRNA profiling at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    Next Generation Sequencing of microRNA species from serum.

  7. serum 25-hydroxy-vitamin D [ Time Frame: baseline ]
    serum 25-hydroxy-vitamin D

  8. Change from baseline in C-reactive protein level at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    C-reactive protein

  9. Change from baseline in quadriceps strength at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in newtons.

  10. Change from baseline in 6 minute walk distance at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    6 minute walk distance

  11. Change from baseline in FRAIL scale at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    FRAIL scale: fatiguability, 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.

  12. Change from baseline in interleukin-6 level at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    Interleukin-6

  13. Change from baseline in interleukin-10 level at 3 months [ Time Frame: baseline and at participant completion, an average of 3 months ]
    Interleukin-10

  14. fNIRS [ Time Frame: baseline and at participant completion, an average of 3 months ]
    functional near infra-red spectroscopy to analyze muscle blood flow in the quadriceps during VO2max test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750006


Locations
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United States, New York
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, United States, 14215
Sponsors and Collaborators
VA Office of Research and Development
VA Western New York Healthcare System
University at Buffalo
Roswell Park Cancer Institute
Investigators
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Principal Investigator: Bruce R. Troen, MD VA Western New York Healthcare System, Buffalo, NY
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03750006    
Other Study ID Numbers: E2902-P
RX002902 ( Other Grant/Funding Number: Veteran Affairs )
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Six months after publication.
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
frailty
sarcopenia
exercise
high intensity
older adults
microRNA
Additional relevant MeSH terms:
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Frailty
Pathologic Processes