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

Frailty Clinical Trial

— HIIT-VA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03750006
• Other study ID #: E2902-P
• Secondary ID: RX002902
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

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.

Locations

Country	Name	City	State
United States	VA Western New York Healthcare System, Buffalo, NY	Buffalo	New York

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	Roswell Park Cancer Institute, University at Buffalo, VA Western New York Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	serum 25-hydroxy-vitamin D	serum 25-hydroxy-vitamin D	baseline
Secondary	Change from baseline in C-reactive protein level at 3 months	C-reactive protein	baseline and at participant completion, an average of 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in interleukin-6 level at 3 months	Interleukin-6	baseline and at participant completion, an average of 3 months
Secondary	Change from baseline in interleukin-10 level at 3 months	Interleukin-10	baseline and at participant completion, an average of 3 months
Secondary	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