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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Frailty
• Intervention / Treatment: Behavioral: Short session HIIT

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • VA Western New York Healthcare System, Buffalo, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline VO2 Max at 3 months	VO2 max, also known as maximal oxygen uptake, will be assessed.	baseline and at participant completion, an average of 3 months
Change from baseline in physical activity enjoyment at 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.	baseline and at participant completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the SPPB at 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.	baseline and at participant completion, an average of 3 months
Change from baseline in frailty phenotype at 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".	baseline and at participant completion, an average of 3 months
Change from baseline in Quality of Life at 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.	baseline and at participant completion, an average of 3 months
Change from baseline in cognition at 3 months	VA-SLUMS: VA Saint Louis University Mental Status screen.	baseline and at participant completion, an average of 3 months
Change from baseline in Activities of Daily Living & Instrumental Activities of Daily Living at 3 months	ADLs: dressing, eating, ambulation, toileting, and hygiene IADLs: shopping, housework, accounting, food preparation, transportation/telephone	baseline and at participant completion, an average of 3 months
Change from baseline in microRNA profiling at 3 months	Next Generation Sequencing of microRNA species from serum.	baseline and at participant completion, an average of 3 months
serum 25-hydroxy-vitamin D	serum 25-hydroxy-vitamin D	baseline
Change from baseline in C-reactive protein level at 3 months	C-reactive protein	baseline and at participant completion, an average of 3 months
Change from baseline in quadriceps strength at 3 months	Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in newtons.	baseline and at participant completion, an average of 3 months
Change from baseline in 6 minute walk distance at 3 months	6 minute walk distance	baseline and at participant completion, an average of 3 months
Change from baseline in FRAIL scale at 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.	baseline and at participant completion, an average of 3 months
Change from baseline in interleukin-6 level at 3 months	Interleukin-6	baseline and at participant completion, an average of 3 months
Change from baseline in interleukin-10 level at 3 months	Interleukin-10	baseline and at participant completion, an average of 3 months
fNIRS	functional near infra-red spectroscopy to analyze muscle blood flow in the quadriceps during VO2max test	baseline and at participant completion, an average of 3 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Roswell Park Cancer Institute; University at Buffalo; VA Western New York Healthcare System
• Investigators: Principal Investigator: Bruce R. Troen, MD, VA Western New York Healthcare System, Buffalo, NY

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: exercise; older adults; frailty; microRNA; sarcopenia; high intensity
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: E2902-P; RX002902 (Other Grant/Funding Number: Veteran Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Time Frame: Six months after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• 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