Clinical trial NCT03750006: Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training
Official title: Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Frailty
Keywords: frailty
sarcopenia
exercise
high intensity
older adults
microRNA
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: The VA Western New York Healthcare System
name: University at Buffalo
name: Roswell Park Cancer Institute
First posted: 2018-11-21
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 6-minute Walk at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Physical Activity Enjoyment at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: VO2max at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
Secondary outcomes:
measure: Short Physical Performance Battery at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Frailty at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Quality of Life Survey at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Cognitive Survey at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: microRNA Profiling at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Serum 25-hydroxy-vitamin D at Baseline
timeFrame: baseline
measure: C-reactive Protein Level at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Quadriceps Strength at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: FRAIL Scale Survey at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Serum Interleukin-6 Level at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Serum Interleukin-10 Level at Baseline and Endpoint
timeFrame: baseline and at participant completion, an average of 3 months
measure: Number of Participants With Muscle Tissue Oxygenation Raw Data Collected
timeFrame: baseline and at participant completion, an average of 3 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: VA Western New York Healthcare System, Buffalo, NY
state: New York
Study officials:
affiliation: VA Western New York Healthcare System, Buffalo, NY
name: Bruce R. Troen, MD
role: PRINCIPAL_INVESTIGATOR
References: