The Multidimensional Effects of Exercise and Nutritional Interventions on Musculoskeletal Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Body Composition: Lean Muscle/Fat Tissue 1) appendicular lean mass (kg) divided by height (meters-squared) and 2) appendicular lean mass divided by body mass index
研究概览
简要总结
This project will investigate the synergistic effects of Aerobic and Resistance type Exercise, in combination with Protein Supplementation, on; Body Composition, Musculoskeletal Functioning, Nutritional Status and Quality of Life in Age-related Sarcopenia.
详细描述
Musculoskeletal ageing is an inevitable process associated with profound morphological and functional changes that will ultimately transition an individual from independent, to dependable living, relying heavily on personal health care for survival. The United Kingdom (UK) population aged over 65 years is expected to rise from 8.8 to 11.3 million by 2025. As life expectancy increases due to advances in medical treatment, an age-related disease termed sarcopenia, has become more prevalent in the elderly. Sarcopenia, described as the loss of musculoskeletal mass, strength and/or physical functioning with age, manifests after the 6th decade and rapidly increases after the 8th decade, resulting in a deterioration of health status and quality of life. To manage the looming health and economic consequences of sarcopenia, suitable therapeutic strategies to manage the condition are warranted. Therefore, this randomised control trial (RCT) will investigate the effects of 16-weeks of exercise and nutritional interventions in inactive senior citizens (60 - 90 years old).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female participants
- •60 - 90 years of age
- •Resident in North West, England, UK
- •BMI 18.5-30 kg/m
- •Can speak and understand English
- •Willing to consent and follow the study procedures
排除标准
- •Recent (i.e. past 3 months) or concurrent participation in any clinical trial or dietary and/or exercise intervention program
- •Self-reported lactose intolerance
- •Uncontrolled diabetes (HbA1C >10)
- •Uncontrolled Hypertension (160/100) and uncontrolled hypotension (<100 systolic)
- •Treatment with Beta Blockers, Calcium Channel Blockers, Digitalis, Bronchodilator,
- •Diuretics, Vasodilators
- •Current hormone therapy such as insulin, testosterone or hormone replacement therapy
- •History of falls/osteoporosis
- •Major psychological/mental illness
- •Medical conditions that precluded safe participation in an exercise program
- •Other major systemic diseases: Liver and kidney diseases, Advanced gastrointestinal disorders, Cardiovascular Diseases, Advanced chronic obstructive pulmonary disease, Advanced Rheumatoid Arthritis, Cancer
结局指标
主要结局
Body Composition: Lean Muscle/Fat Tissue 1) appendicular lean mass (kg) divided by height (meters-squared) and 2) appendicular lean mass divided by body mass index
时间窗: 16 weeks
次要结局
- Grip Strength: Hand Grip Dynanometer (kg)(16 weeks)
- Time to complete five chair rises (m/s)(16 Weeks)
- Biochemical: Glycated Haemoglobin (HBA1c) (%)(16 Weeks)
- Biochemical: Insulin-Like Growth Factor 1 (IGF-1) (ng/ml)(16 Weeks)
- Exercise Tolerance: Six Minute Walk Test (metres)(16 Weeks)
- Gait speed during timed 4-meter walk (m/s)(16 Weeks)
- Balance assessment: 1) feet side to side, 2) semi-tandem, 3) full tandem, and 4) single leg. Scored as Yes or No.(16 Weeks)
- Isometric Strength - Knee Flexion/Extension: Dynanometer (Nm/Kg)(16 Weeks)
- Biochemical: C-Reactive Protein (CRP) (mg/L)(16 Weeks)
- Arterial Pressure: Pulse Wave Velocity (m/s)(16 Weeks)
- World Health Organization Quality Of Life Assessment (WHOQOL): Each question is scored from 1-5 on a response scale(16 Weeks)
- Muscle Fatigue: Upper & Lower limb: 25% of MVC during 60 seconds using Electromyography (EMG), measured in millivolts (mV)(16 Weeks)
- Energy Balance: Periodic Food Diary (Kcal)(16 Weeks)
- 10-metre Gait analysis during habitual walking speed using Electromyography (EMG)(16 Weeks)
- 10-metre Gait analysis during habitual walking speed using Three-Dimensional Motion Capture - 1) Spatiotemporal, 2) Kinematics(16 Weeks)
- Short-Form Health Survey (SF-12): Each question is scored between 1-6 on a response scale(16 Weeks)
- Activities of Daily Living (ADL): Each response is scored as either: 0 or 1(16 Weeks)
- Mini-Mental State Examination (MMSE): Each correct response is scored as 1 point(16 Weeks)
- Nutritional Status: Mini-Nutritional Assessment (MNA) - Classified as (Low, Moderate, High risk)(16 weeks)
研究者
Omid Khaiyat, MD, PhD
Dr
Liverpool Hope University