Buffalo, New York 14215


Purpose:

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 summary:

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.


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


NCT ID:

NCT03750006


Primary Contact:

Principal Investigator
Bruce R. Troen, MD
VA Western New York Healthcare System, Buffalo, NY

Ayesha Rahman, MS
Phone: (716) 862-8944
Email: ayesha.rahman2@va.gov


Backup Contact:

Email: seldeen@buffalo.edu
Kenneth Seldeen, PhD
Phone: (716) 888-4869


Location Contact:

Buffalo, New York 14215
United States

Jeffery M Mador, MD
Phone: 716-862-6528
Email: Jeffery.Mador@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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