跳至主要内容
临床试验/NCT03750006
NCT03750006终止不适用

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

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
42
试验地点
2
主要终点
6-minute Walk at Baseline and Endpoint

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Frail, pre-frail, and non-frail
  • Medical clearance for exercise

排除标准

  • 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

结局指标

主要结局

6-minute Walk at Baseline and Endpoint

时间窗: 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

时间窗: 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

时间窗: baseline and at participant completion, an average of 3 months

Performed as part of a symptom limited maximal endurance test on a cycle ergometer

次要结局

  • Short Physical Performance Battery at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • Frailty at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • Quality of Life Survey at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • Cognitive Survey at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • microRNA Profiling at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • Serum 25-hydroxy-vitamin D at Baseline(baseline)
  • C-reactive Protein Level at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • Quadriceps Strength at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • Number of Participants With Muscle Tissue Oxygenation Raw Data Collected(baseline and at participant completion, an average of 3 months)
  • FRAIL Scale Survey at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • Serum Interleukin-6 Level at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)
  • Serum Interleukin-10 Level at Baseline and Endpoint(baseline and at participant completion, an average of 3 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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