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临床试验/NCT03771417
NCT03771417已完成不适用

Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Skeletal Muscle and Cardiometabolic Health in Older Adults-REALPA Breaks in Sedentary Time Pilot Study

Louisiana State University and A&M College4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
4
主要终点
Skeletal Muscle Strength

研究概览

简要总结

What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults?

What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal cardiometabolic health in older adults?

详细描述

Although awareness of the detrimental impact that sedentary behavior has on skeletal muscle and cardiometabolic health has increased over the last 20 years, more than 60% of older adults remain sedentary for greater than 8 hours per day. Moreover, 80% to 90% of adults 60 years of age or older do not meet the current public health guidelines for aerobic exercise (AE) or resistance exercise (RE) based physical activity (PA). Collectively, these adverse health behaviors contribute to the development of multiple chronic medical conditions commonly afflicting older adults, including type 2 diabetes, cardiovascular disease, sarco/dynapenia, frailty, and premature mortality. Emerging evidence suggests that breaking up sedentary time with light intensity PA (LPA) improves muscle and cardiometabolic health. Recent data also suggest that RE combined with moderate intensity AE effectively improves muscle and cardiometabolic health in older adults. However, the impact that RE combined with LPA breaks in sedentary time has on muscle and cardiometabolic health in older adults remains unknown. The overall objective of this pilot study is to determine the effect of 16 weeks of RE alone or RE combined with LPA breaks in sedentary time on muscle and cardiometabolic health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Are capable and willing to give written informed consent, and understand exclusion criteria
  • 65-80 years of age inclusive
  • Body Mass Index (BMI) between 18.5-34.9 kg/m2, inclusive
  • Physically inactive determined by self-report
  • Stable medical therapy for allowable medications for 30 days defined as:
  • No addition or removal of a medication
  • No change in dosage of a medication
  • Having no life-threatening conditions or diseases
  • Willing to allow researchers to use data, bio-specimens (blood and muscle tissue), and images (e.g., magnetic resonance imaging) for research purposes after study participation is completed
  • At least 2 weeks post-completion of the COVID19 vaccine regimen. a. Acceptable proof of vaccine includes a completed vaccine card and/or letter from a healthcare provider indicating the date that the COVID19 vaccine was completed.

排除标准

  • Nursing home resident
  • Physically Active:
  • a. > 100 min/wk of moderate OR > 50 min/wk vigorous intensity PA
  • Saint Louis University Mental State (SLUMS) score < 21
  • Evidence or self-report history of deep vein thrombosis, pulmonary embolism, cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
  • Evidence or self-report history of type 1 or 2 diabetes mellitus
  • Evidence or self-report history of a bleeding disorder
  • Evidence or self-report history of recurrent vasovagal episodes
  • Evidence or self-report history of severe depression, Schizophrenia, bipolar disease
  • Evidence or self-report history of mobility disability requiring a walker, wheel chair, or inability to walk across a small room.
  • Evidence or self-report history of orthopedic limitations that would preclude them from participation in a dynamic exercise program
  • Evidence or self-report history of severe arthritis (either osteoarthritis or rheumatoid arthritis) that would preclude them from participation in a dynamic exercise program
  • Evidence or self-report of history untreated thyroid dysfunction.
  • Weight loss of > 10% in the last 3 months prior to screening
  • History of weight loss surgery.
  • Use of medications known to influence study outcomes, such as:
  • Oral antidiabetic medications (e.g., metformin)
  • Corticosteroids
  • Beta-blockers
  • c. Anticoagulants
  • Allergy to lidocaine
  • Active smoking
  • Current consumption of > 14 alcoholic drinks per week based on self-report
  • Regular participation in resistance or aerobic exercise training within 3 months of initial screening
  • Absolute Contraindication to Exercise as Defined by the American College of Sports Medicine,16 including:
  • Resting diastolic blood pressure > 100 mm Hg
  • Resting systolic blood pressure > 180 mm Hg
  • Resting heart rate > 100 beats per min
  • Having a body weight greater than 440 pounds
  • Having medical implants such as a pacemaker or metal joint replacements
  • Having tattoos or permanent makeup completed <30 days prior to the visit
  • Recent (past 3 months) cancer diagnosis, undergoing immunotherapy, taking immune suppressants
  • Presence of allergies or infections requiring antibiotics within the past 14 days
  • Recent (past 3 months) major surgery on the abdomen, pelvis, or lower extremities
  • Any other condition that in the judgement of the Principal Investigator and/or the Medical Director of this protocol may interfere with study participation and adherence to the protocol.
  • Evidence or self-report history of severe depression in the last 5 years.

结局指标

主要结局

Skeletal Muscle Strength

时间窗: Measured at week 0 (baseline) and week 16

The investigators will determine the change from baseline in skeletal muscle strength. These measurements will be performed at baseline and following 16 weeks of exercise training using isokinetic dynamometry and 1 repetition maximum testing.

Skeletal Muscle Mass

时间窗: Measured at week 0 (baseline) and week 16

The investigators will determine the change from baseline in skeletal muscle mass. These measurements will be performed at baseline and following 16 weeks of exercise training using Dual X-Ray Absorptiometry.

次要结局

  • Mitochondrial Function(Measured at week 0 (baseline) and week 16)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Irving

Associate Professor

Louisiana State University and A&M College

研究点 (4)

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