Effect of a Power/Resistance Exercise Program and Oral Supplementation With Beta-hydroxy-beta-methyl Butyrate (HMB) on the Muscle Quality Index in Older Adults. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- Mean change from baseline arm Muscle Quality Index (MQIarm)
研究概览
简要总结
The aging process is accompanied by a decrease in several biological and physical functions, which have an impact on the perception of well-being and quality of life. Among these, the decrease in muscle mass, strength and power are of particular importance as they are associated with poor cardiorespiratory function, functional limitations and mortality. The muscle quality index (MQI) is considered a key determinant of muscle function in adulthood. The main treatment to preserve muscle mass has been strength exercise and in some cases the use of aids that influence protein metabolism such as beta-hydroxy-beta-methyl butyrate (HMB), but the evidence on this topic is not consistent and is inconclusive. Therefore, the main purpose of this study is to investigate if the combination of a power/resistance exercise program and oral supplementation with HMB can improve the quality mass index in adults aged compared with those received a single exercise program after 14 weeks of intervention.
详细描述
Study design: this is a 14-week, randomized controlled trial. 76 participants will be recruited from the medical services of the National Institute of Rehabilitation (NIR).
Participants: Adults between 65-75 years old, with a body mass index between 25-30 kg/m^2, sedentaries, non-smokers, with compensated comorbidities, and who do not consume nutritional supplements will be recruited. Participants with uncompensated metabolic diseases, with high risk of falls (evaluated with Tinetti scale), frailty syndrome, and b2-adrenergic agonists, glucocorticoids, diuretics or peripheral vasodilators users will not be recruited.
Intervention: Participants will be randomized to 1) power/resistance exercise program (GEx), 2) power/resistance exercise program + HMB group (GExHMB) with computer-generated random numbers. The exercise program will consist of training to improve muscular strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. Every training session will consist of 15 minutes of warm-up, 40 to 60 minutes of power/resistance training, neuromuscular and aerobic exercises, and 15 minutes of cool-down. The power/resistance and neuromuscular training will be performed 3 days/week, 2-5 sets, 5-15 repetitions for each exercise according to the recommendation of the American College of Sports Medicine training progression models; the aerobic exercise will be performed 2 days/week. All exercises will be performed at moderate intensity and will take place in the NIR Sports Medicine therapeutic gym.
Oral supplementation with HMB will be from a commercial polymeric formula in liquid form (Ensure Advanced®, 230 ml); the supplement intake will be 1 bottle/day. All patients, regardless of the intervention, will be monitored by sports medicine physicians and nutritionists in order to promote adherence to treatment.
The muscle quality index (MQI) will be obtained from the determination of muscular strength by isokinetic dynamometry (at 60°/s) for the lower extremities and by hand dynamometry for the upper extremities; the lean segmental mass in the upper and lower extremities will be determined by 3-frequency electronic bioimpedance analysis. The MQI will be calculated from the muscular strength divided by the muscular mass.
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
- None
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index 25-30 km/m^2
- •Appendicular skeletal muscle mass index in women ≥ 5.0 kg/m^2 and men ≥ 6.0 kg/m^2
- •No regular exercise
- •Non-smokers
- •Compensated comorbidities
- •Without consumption of nutritional supplements
排除标准
- •Osteoporosis
- •Cardiovascular diseases (recent heart attack, unstable angina, heart failure, complete atrioventricular block)
- •Musculoskeletal injuries
- •Severe cognitive impairment
- •Major depressive disorder
- •Thyroid diseases
- •Anemia with no response to previous treatment in the last 3 months
- •b2-adrenergic agonists, glucocorticoids, diuretics or peripheral vasodilators users
- •With amino acid and vitamin D supplementation or suspended with less than 3 months
- •Data of renal insufficiency
- •Chronic obstructive pulmonary disease
- •Malabsorption syndrome associated with malnutrition
- •High risk of falls evaluated with the Tinetti scale (score ≤19)
- •Frailty syndrome
结局指标
主要结局
Mean change from baseline arm Muscle Quality Index (MQIarm)
时间窗: Baseline and 14 weeks
The muscle quality index from dominant arm will be calculated with data obtained from hand grip strength, and lean mass obtained by bioimpedance analysis according with the formula: MQIarm = hand grip strength (kg) / arm lean mass (kg)
Mean change from baseline leg Muscle Quality Index (MQIleg)
时间窗: Baseline and 14 weeks
The muscle quality index from dominant leg will be calculated with data obtained by isokinetic, and lean mass obtained by bioimpedance analysis according with the formula: MQIleg = peak torque (Nm) / leg lean mass (kg)
次要结局
- Mean change from baseline muscular power(Baseline and 14 weeks)
- Health-related quality of life(Baseline and 14 weeks)
- Short Physical Performance Battery (SPPB)(Baseline and 14 weeks)
研究者
Ariadna del Villar Morales
Medical Specialist in Physical Activity and Sports Medicine
Instituto Nacional de Rehabilitacion