Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in 6 Minute Walk Distance
研究概览
简要总结
Obesity is a major risk factor for mobility problems in older adults and many older adults use a walking aid to help with their mobility. The use of a walking aid changes normal walking patterns and makes walking harder, leading people to have more functional problems. The purpose of this study is to test the effects of 12 months of a multi-modal balance intervention (MMBI) with supervised weight loss compared to MMBI only on fitness, functional performance, balance, and economy of gait. Participants will be one of 120 participants in the VA Maryland Health Care System (VAMHCS). Participation in this study is voluntary. The research will be conducted at the VAMHCS. The entire study will take approximately 4 years to complete. Subjects' participation in the study will last 24 months.
详细描述
Note: Study has been completed, enrollment and study interventions were severely impacted by coronavirus disease 2019 (COVID)
Older obese adults suffer disproportionately from walking mobility limitations. Sedentary, obese older adults are at an increased risk for having or developing difficulties with mobility. These individuals are often excluded from studies due to their advanced mobility limitations. A number of studies have compared the effects of weight loss alone, exercise alone, or weight loss in combination with exercise on functional performance in older adults, but none of the studies have specifically targeted subjects who use walking assistive devices. The purpose of this study is to test the effects of a 12 month multi-modal exercise rehabilitation intervention with a nutrition program versus a nutrition program only on fitness, functional performance, mobility, and muscle mass. The results of this study will lead to new and more effective interventions that could reduce disability, fall risk, injury-related hospitalization and death in older Veterans.
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
- Single (Outcomes Assessor)
盲法说明
Assessor blinded to group, statistical analyses blinded to group
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 60
- •Body Mass Index (BMI) >= 30 kg/m2
- •Dysmobility as define by 1 or more of the following: Use of or prescribed an assistive walking device, measured gait speed < 1.0 m/s, Four Square Step Test >/= 12 secs OR inability to complete the Four Square Step Test, and/or self-reported difficulty walking 1 km.
- •Community dwelling
排除标准
- •Unable to walk >0.2 mph on a treadmill for 2 minutes
- •Poorly controlled hypertension >180 systolic or >100 diastolic
- •Episodes of acute coronary syndrome, coronary revascularization, or major cardiac/vascular procedures within the prior 6 months
- •New York Heart Association Class 3 or 4 heart failure
- •Symptomatic angina at rest or during exercise
- •Syncope within the past 12 months without known cause or resolution
- •Chronic lung disease required oxygen dependency
- •Severe spinal stenosis limiting ambulation
- •Known dementia
- •Mini Mental State Exam score <24
- •Transtibial or above the knee amputation
- •Currently enrolled and active in a supervised exercise program or Weight Management Program for Veterans (MOVE)
- •Poorly controlled diabetes as defined by HbA1C >10% or frequent hypoglycemic episodes
- •Currently undergoing chemotherapy and/or radiation therapy for cancer treatment
结局指标
主要结局
Change in 6 Minute Walk Distance
时间窗: 6 months
Distance walked during the 6 minute walking test
次要结局
- Change in Short Physical Performance Battery(baseline, 3 months)
- Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement(6 months)
- Change in Gait Biomechanics(6 months)
- Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan(baseline, 6 months)
- Change in Four Square Step Test(baseline, 3 months)
- Change in 8 Foot up and go(baseline, 3 months)