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

Not Applicable

Terminated

Conditions: Frailty

Interventions: Behavioral: Short session HIIT

Registration Number: NCT03750006

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 42

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIIT intervention	Short session HIIT	Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.

Primary Outcome Measures

Name	Time	Method
6-minute Walk at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace.
Physical Activity Enjoyment at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 questions, each of which can receive a score from 1 to 7, where 7 is represents greater enjoyment. Scores presented as the mean across all questions giving an overall range of 1-7.
VO2max at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	Performed as part of a symptom limited maximal endurance test on a cycle ergometer

Secondary Outcome Measures

Name	Time	Method
Short Physical Performance Battery at Baseline and Endpoint	baseline and at participant completion, an average of 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 from 0 to 4 points. Therefore the total range of the test spans summed scores from 0 to 12, where 12 is the best outcome.
Frailty at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	Fried frailty phenotype assessment includes: gait speed, grip strength, endurance, activity level, weight loss. These assessments report summed scores of 0 to 5, where 0 is the best outcome. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) for 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".
microRNA Profiling at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	Next Generation Sequencing of microRNA species from serum.
Serum 25-hydroxy-vitamin D at Baseline	baseline	serum 25-hydroxy-vitamin D was measured from serum isolated from blood collected at baseline and measured using ELISA
Quality of Life Survey at Baseline and Endpoint	baseline and at participant completion, an average of 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, where 5 is the better outcome. Therefore the total range of the test spans scores from 14 to 70, where 70 is the best outcome. The final score as a percentage with range being 0-100% and top being 100%. This percentage is calculated as: 100 \* ((participant's score - 14) / 56).
Cognitive Survey at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	VA-SLUMS: VA Saint Louis University Mental Status screen. Survey includes 11 questions allowing a range of scores from 1-30 points, where higher scores represent greater mental outcomes.
Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	The Activities of Daily living and instrumental activities of daily living are a survey comprised of 14 questions including ability to: dress, eat, ambulate, toilet, hygiene, shop, housework, accounting, food preparation, and use transportation/telephone. Each question gives up to 1 point with a total range of 0-14. Higher scores indicate less independence and greater reliance on support.
C-reactive Protein Level at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	C-reactive protein was measured from isolated serum samples at baseline and endpoint using ELISA
Quadriceps Strength at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in kilograms (kg) of force.
FRAIL Scale Survey at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	FRAIL scale: fatigability, 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. Higher scores represent greater frailty.
Serum Interleukin-6 Level at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	Interleukin-6 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA
Serum Interleukin-10 Level at Baseline and Endpoint	baseline and at participant completion, an average of 3 months	Interleukin-10 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA
Number of Participants With Muscle Tissue Oxygenation Raw Data Collected	baseline and at participant completion, an average of 3 months	Seeking to collect raw data using functional near infra-red spectroscopy to analyze quadriceps during VO2max test. This work is the first steps in the development of techniques that analyze muscle blood flow and tissue oxygenation during exercise.