Efficacy of Nutritional Supplementation on Physical-activity Mediated Changes in Physical Functioning Older Adults at Risk for Mobility Disability (The VIVE2 Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Time to Walk 400 meters
研究概览
简要总结
Several trials have found that nutritional supplementation can elicit an increased rate of skeletal muscle protein synthesis following a single bout of exercise in both young and older individuals. However, there have been no studies that have investigated if nutritional supplementation and exercise can cause a sustained increase in physical functioning and fat free mass, particularly in older adults with functional limitations. This study will compare the effects of a nutritional supplement versus a placebo on exercise training induced changes in physical functioning older adults who are at risk for mobility disability.
详细描述
Exercise Intervention: Participants will complete exercise sessions 3 times per week for 6 months. The exercise sessions will involve walking, lower extremity strength exercises, flexibility, and balance training.
Supplement Intervention: Participants will be randomly assigned to receive either the nutritional supplement or placebo. The participants will consume on beverage immediately after each exercise session.
Primary Outcome: The primary outcome will be the time to walk 400 meters, expressed as average gait speed during the 400 M walk. All participants must be able to walk 400 meters in <15 minutes at walking at their normal speed. The 400 M walk will be assessed at baseline, 3-months, and 6-months, with the changes at 6-months being the primary outcome.
Secondary Outcome Measures:
- Stair Climb Test
- Body Composition
- Skeletal muscle cross sectional area
- Isokinetic/Isometric peak torque/power
- Hand-grip strength
- Nutritional status
- Quality of Life/Depressive symptoms Expected enrollment: 150 (80 at Tufts University (Boston, MA, USA), 70 at University of Uppsala (Uppsala, Sweden))
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male & Female ≥ 70 yrs
- •Community dwelling
- •Short Physical Performance Battery ≤ 9
- •Willingness to be randomized and come to the laboratory for 6 months
- •Body Mass Index < 35
- •Mini-Mental State Examination >=24
- •Serum 25 (OH) D (22.5 -50 nmol/l)
- •Having obtained his/her informed consent
- •Able to complete 400 M walk within 15 minutes
排除标准
- •• Acute or terminal illness; terminal illness with life expectancy less than 12 months, as determined by a physician
- •Current regular use (> 1 per week) of high protein oral nutritional supplements (eg: Boost, Exceed etc...)
- •Current use of Vitamin D supplements, >800 IU/day
- •Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure.
- •Upper or lower extremity fracture in previous 6 months.
- •Hemoglobin < 10 g/dL, Estimated GFR < 30 mL/min/1.73 m2
- •Uncontrolled hypertension (>150/90 mm Hg).
- •Neuromuscular diseases and drugs which affect neuromuscular function; severe progressive, degenerative neurologic disease
- •Hormone replacement therapy
- •Insulin-dependent diabetes mellitus
- •Milk protein allergy
- •Major surgery in the past 6 months (requiring general anesthesia)
- •Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia)
- •Excessive alcohol use (>14 drinks per wk)
- •Participation in moderate intensity physical activity > 20 minutes/week
- •Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
- •Severe visual impairment (if it precludes completion of assessments and/or intervention)
- •Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease; wheelchair bound
- •Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
- •Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
- •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
- •Patient who cannot be expected to comply with treatment, as decided by the Principal Investigator and study physician.
- •Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site Principal Investigator and/or study physician.
研究组 & 干预措施
Placebo
干预措施: Supplement Intervention (Dietary Supplement)
Exercise
干预措施: Exercise Intervention (Other)
Supplement
干预措施: Supplement Intervention (Dietary Supplement)
结局指标
主要结局
Time to Walk 400 meters
时间窗: 6-Month
The primary outcome will be the time to walk 400 meters, expressed as average gait speed during the 400 M walk. All participants must be able to walk 400 meters in \<15 minutes at walking at their normal speed. The 400 M walk will be assessed at baseline, 3-months, and 6-months, with the changes at 6-months being the primary outcome.
次要结局
未报告次要终点