NCT00714506已完成不适用
Effects of a Weight Reduction and Lifestyle Program in Older Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- time to walk 400 m
研究概览
简要总结
This research study will assess the effects of two different programs on weight, body composition, mobility and improved health. Measures of health will include functional abilities, and physical performance. The 2 programs being tested will be provided the same physical activity program which will include aerobic activity and resistance (weight) training. The intervention study will last up to 1 year with follow-up at 6 months and yearly phone calls thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 and older
- •BMI 28 to 39.9
- •Sedentary lifestyle defined by formal exercise less than 3 times per week for a total of less than 90 minutes.
- •Self report of ability to walk ¼ mile (2-3 blocks)
- •Ability to complete the 400 meter walk without a cane or walker in less than 15 minutes
- •Successful completion of the behavioral run-in phase which includes an activity log and a food diary
- •Willingness to be randomized to either intervention group
- •Willingness to attend meetings and physical activity sessions in McKeesport
排除标准
- •Diabetes requiring insulin, history of diabetic coma, or diabetes out of control defined as fasting blood sugar greater than 300
- •Severe hypertension, e.g. SBP> 180, DBP > 100
- •Failure to provide informed consent
- •Nursing home resident or resident in a facility where they have no control over food choices
- •Significant cognitive impairment, defined as a known diagnosis of dementia or a 3MSE Cognitive Function score < 80
- •Major psychiatric disorder
- •Unable to communicate because of severe hearing loss or speech disorder
- •Severe visual impairment
- •Celiac sprue or other malabsorption syndromes
- •Consume more than 5 alcoholic drinks per day, or more than 15 drinks per week
- •Progressive, degenerative neurological disease
- •Severe rheumatologic or orthopedic diseases
- •Stroke, hip, or knee replacement, or spinal surgery within the past 4 months or planned in the next 4 months
- •Receiving physical therapy for gait, balance, or lower extremity training
- •Terminal illness with life expectancy of less than 12 months
- •Currently being treated with chemotherapy or radiation for breast, cervical, colon, prostate, rectal, uterine, thyroid, or oral cancer. Participant with other types of cancers, with the exception of basal and squamous cancer are ineligible
- •Severe pulmonary disease (i.e., lung disease requiring supplemental oxygen or oral steroid medication) or pulmonary embolism or deep vein thrombosis within the past 6 months
- •Severe cardiac disease (i.e., congestive heart failure (NYHA Class III or IV); untreated aortic stenosis; a history of cardiac arrest, the use of a cardiac defibrillator or uncontrolled angina)
- •Myocardial infarction, CABG, or valve replacement in the past 6 months
- •Serious conduction disorder (3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST- segment depressions (> 3mm) on ECG
- •Other significant co-morbid disease that the study medical officer deems severe enough to impair ability to participate in exercise based intervention
- •Severe kidney disease that requires dialysis
- •Develops chest pain or severe shortness of breath during 400 m walk test
- •Member of household is already enrolled
- •Participation in another intervention trial: participation in an observational study is permitted
- •People who have lost more than 10 pounds in the past 4 months, or are on any drugs for the treatment of obesity
- •Lives outside of the study site area or is planning to move in the next year
- •Must be able to attend at least 6 of the first 8 weekly sessions.
研究组 & 干预措施
Control
Active Comparator
physical activity plus successful aging health education
干预措施: Physical activity control (Other)
Intervention
Experimental
lifestyle weight reduction - low fat eating, low calorie and physical activity
干预措施: Diet and physical activity (Behavioral)
结局指标
主要结局
time to walk 400 m
时间窗: at 6 mo intervals
次要结局
- weight loss(6 month intervals)
研究者
Anne B. Newman
Professor of Epidemiology
University of Pittsburgh
研究点 (1)
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