Resveratrol and Exercise to Treat Functional Limitations in Late Life
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Walking Speed
研究概览
简要总结
The purpose of this research study is to evaluate the effects of combining physical exercise with a resveratrol supplementation on the physical function of older adults.
详细描述
This investigation is a pilot study to investigate the potential of resveratrol, a commercially-available nutritional product, to enhance the efficacy of physical exercise in improving physical function among older adults with functional limitations. The overarching objective of this project is to evaluate the safety and efficacy of an intervention combining resveratrol supplementation and physical exercise among sedentary persons aged > 65 years objectively-measured functional impairments. A total of 60 participants will be recruited to participate in this three month intervention study. All participants will engage in a center-based exercise program 3/days per week and will be randomly assigned to consume 1) placebo, 2) 500 mg/day resveratrol, or 3) 1000 mg/day resveratrol. This study will provide critical information regarding the influence of the combination of resveratrol and exercise on objectively-measured and self-assessed indices of physical function. The study will also provide novel biologic information regarding the relative effects of the interventions on skeletal muscle mitochondrial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand study procedures and to comply with them for the entire length of the study
- •Willingness to be randomized into either treatment group
- •Age 65 years and older
- •Physical limitations evidenced by >290 seconds needed to complete long-distance corridor walk test
- •Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire
排除标准
- •Failure to provide informed consent
- •Regular consumption of a resveratrol supplement
- •Current involvement in supervised rehabilitation program
- •Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines
- •Pain classification > Grade 3 on Graded Chronic Pain Scale
- •Peripheral vascular disease; peripheral neuropathy; retinopathy
- •Severe cardiac disease, including:
- •NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- •Myocardial infarction or stroke within past year
- •Significant cognitive impairment, including:
- •known dementia diagnosis or a Mini-Mental State Examination exam score <24
- •Progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
- •Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)
- •Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
- •Hip fracture, hip or knee replacement, or spinal surgery within past 4 mos.
- •Other significant co-morbid conditions that would impair ability to participate in the exercise-based intervention
- •Simultaneous participation in another intervention trial
研究组 & 干预措施
Placebo + exercise
Placebo capsules will be taken orally daily in combination with exercise
干预措施: Placebo (Drug)
Placebo + exercise
Placebo capsules will be taken orally daily in combination with exercise
干预措施: Exercise (Behavioral)
Resveratrol 500 mg/day + exercise
500 mg/day resveratrol taken orally in combination with exercise
干预措施: Resveratrol (Drug)
Resveratrol 500 mg/day + exercise
500 mg/day resveratrol taken orally in combination with exercise
干预措施: Exercise (Behavioral)
Resveratrol 1000 mg/day + exercise
1000 mg/day resveratrol taken orally in combination with exercise
干预措施: Resveratrol (Drug)
Resveratrol 1000 mg/day + exercise
1000 mg/day resveratrol taken orally in combination with exercise
干预措施: Exercise (Behavioral)
结局指标
主要结局
Walking Speed
时间窗: Change at Baseline to 12 weeks
Walking speed is assessed by asking the participants to walk at their usual pace over a 4 m course. Participants are to stand with both feet touching the starting line and to start walking after a verbal command is given, and the time needed to complete the entire distance will be recorded. The faster of two walks will be used and changes between the groups at baseline and 12 weeks will be assessed.
次要结局
- Short Physical Performance Battery (SPPB).(Change between baseline to 12 weeks)
- Isokinetic Strength.(Change between baseline and 12 weeks)
- 6-minute Walk Test(Change between Baseline and 12 weeks)
- Late-Life Function and Disability Instrument(Change at Baseline to 12 weeks)