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

Primary Purpose

Frailty

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short session HIIT
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring frailty, sarcopenia, exercise, high intensity, older adults, microRNA

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Western New York Healthcare System, Buffalo, NY

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIIT intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline VO2 Max at 3 months
VO2 max, also known as maximal oxygen uptake, will be assessed.
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.

Secondary Outcome Measures

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.
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".
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.
Change from baseline in cognition at 3 months
VA-SLUMS: VA Saint Louis University Mental Status screen.
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
Change from baseline in microRNA profiling at 3 months
Next Generation Sequencing of microRNA species from serum.
serum 25-hydroxy-vitamin D
serum 25-hydroxy-vitamin D
Change from baseline in C-reactive protein level at 3 months
C-reactive protein
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.
Change from baseline in 6 minute walk distance at 3 months
6 minute walk distance
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.
Change from baseline in interleukin-6 level at 3 months
Interleukin-6
Change from baseline in interleukin-10 level at 3 months
Interleukin-10
fNIRS
functional near infra-red spectroscopy to analyze muscle blood flow in the quadriceps during VO2max test

Full Information

First Posted
November 9, 2018
Last Updated
May 19, 2022
Sponsor
VA Office of Research and Development
Collaborators
VA Western New York Healthcare System, University at Buffalo, Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03750006
Brief Title
Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training
Acronym
HIIT-VA
Official Title
Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Western New York Healthcare System, University at Buffalo, Roswell Park Cancer Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
frailty, sarcopenia, exercise, high intensity, older adults, microRNA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIIT intervention
Arm Type
Experimental
Arm Description
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Intervention Type
Behavioral
Intervention Name(s)
Short session HIIT
Intervention Description
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Primary Outcome Measure Information:
Title
Change from baseline VO2 Max at 3 months
Description
VO2 max, also known as maximal oxygen uptake, will be assessed.
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in physical activity enjoyment at 3 months
Description
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.
Time Frame
baseline and at participant completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Change from baseline in the SPPB at 3 months
Description
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.
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in frailty phenotype at 3 months
Description
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".
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in Quality of Life at 3 months
Description
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.
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in cognition at 3 months
Description
VA-SLUMS: VA Saint Louis University Mental Status screen.
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in Activities of Daily Living & Instrumental Activities of Daily Living at 3 months
Description
ADLs: dressing, eating, ambulation, toileting, and hygiene IADLs: shopping, housework, accounting, food preparation, transportation/telephone
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in microRNA profiling at 3 months
Description
Next Generation Sequencing of microRNA species from serum.
Time Frame
baseline and at participant completion, an average of 3 months
Title
serum 25-hydroxy-vitamin D
Description
serum 25-hydroxy-vitamin D
Time Frame
baseline
Title
Change from baseline in C-reactive protein level at 3 months
Description
C-reactive protein
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in quadriceps strength at 3 months
Description
Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in newtons.
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in 6 minute walk distance at 3 months
Description
6 minute walk distance
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in FRAIL scale at 3 months
Description
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.
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in interleukin-6 level at 3 months
Description
Interleukin-6
Time Frame
baseline and at participant completion, an average of 3 months
Title
Change from baseline in interleukin-10 level at 3 months
Description
Interleukin-10
Time Frame
baseline and at participant completion, an average of 3 months
Title
fNIRS
Description
functional near infra-red spectroscopy to analyze muscle blood flow in the quadriceps during VO2max test
Time Frame
baseline and at participant completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce R. Troen, MD
Organizational Affiliation
VA Western New York Healthcare System, Buffalo, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Western New York Healthcare System, Buffalo, NY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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