Physical Activity as Intervention Against Age-related Loss of Muscle Mass and Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 451
- 试验地点
- 2
- 主要终点
- Change in leg extensor power
研究概览
简要总结
A minimum of 450 healthy individuals (62-70 years old) will be recruited.
Each individual will be randomized into one of three groups stratified according to gender (M/F), BMI (≤28/>28), and 30 sec chair stand (≤11/>11). The three groups are Heavy resistance training (n=150), moderate intensity training (n=150), and control (n=150, no training).
Assessments will be performed at baseline, after 12 months of intervention. Furthermore, follow up will be performed after 2,4,7, and 10 years.
The primary outcome is change in leg extensor power after the intervention and during follow up.
The primary hypothesis is that by applying the intention-to-treat analysis, the moderate intensity training group will increase leg extensor power just as much as the heavy resistance training group. The two training groups will increase muscle power more than the control group.
详细描述
Retirement has been recognized as a critical turning point in determining physical activity behaviours in old age. The literature gives a varying picture regarding change in physical activity level with work retirement but often a reduction in total physical activity has been reported. Retirement typically takes place at a time where the skeletal muscle mass, -strength and -power declines by 1-3% per year.
Interventions to promote physical activity in adults aged 55 to 70 years have been shown to be effective at 12 months but it is very unclear if the effect is maintained thereafter. Both exercise at home or at a center improves health and physical function - but home based programs appear to be superior to center based programs in terms of adherence to exercise especially in the long-term.
In older adults, strength training at 60% of 1RM has been shown to be sufficient for large effect on muscle function and muscle protein synthesis, and potentially lower loads (45-60% 1RM) have effect when adding more repetitions.
The overall objective of the study is to assess the long-term effects of 12 month of supervised high-intensity center based resistance training or "guided" moderate-intensity home-based resistance training relative to a non-exercising control group upon muscle power, -strength and -mass, physical function, physical activity level and health in older people around the time of retirement.
The hypotheses are:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 62 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Independently living men and women
- •Between 62 and 70 years
排除标准
- •Subjects dependent on help/nursing etc.
- •Severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, non-treated hyper/hypothyroidism, dementia, active cancer.
- •Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens.
- •Implanted magnetic devices incompatible with MRi-scanning.
- •>1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation.
研究组 & 干预措施
Heavy resistance training
Heavy resistance training of the lower and upper extremities three times weekly for 52 weeks.
干预措施: Heavy resistance training (Other)
Moderate intensity training
Home-based moderate intensity training of the lower and upper extremities three times weekly for 52 weeks.
干预措施: Moderate intensity training (Other)
Control
No training
干预措施: Control (Other)
结局指标
主要结局
Change in leg extensor power
时间窗: Baseline, 1, 2, 4, 7, and 10 years follow up
Unilateral leg extension power measured in the Leg Extensor Power Rig device (Nottingham). The primary time interval for assessment of the primary outcome measure is from baseline to 12 months intervention. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing the three groups before/after the intervention and during follow up (1,2,4,7, and 10 years).
次要结局
- Change in Exercise self-efficacy(Baseline, 1, 2, 4, 7, and 10 years)
- Change in personality(Baseline, 1, 2, 4, 7, and 10 years)
- Change in 400 m gait speed(Baseline, 1, 2, 4, 7, and 10 years)
- Change in grip strength(Baseline, 1, 2, 4, 7, and 10 years)
- Change in cognitive ability(Baseline, 1, 2, 4, 7, and 10 years)
- Change in maximal isometric quadriceps strength(Baseline, 1, 2, 4, 7, and 10 years)
- Change in perceived age(Baseline, 1, 2, 4, 7, and 10 years)
- Change in physical activity level(Baseline, 1, 2, 4, 7, and 10 years)
- Change in Health Related Quality of Life(Baseline, 1, 2, 4, 7, and 10 years)
- Change in quadriceps cross sectional area(Baseline, 1, 2, 4, 7, and 10 years)
- Change in blood parameters and anthropometry(Baseline, 1, 2, 4, 7, and 10 years)
- Change in mental symptoms(Baseline, 1, 2, 4, 7, and 10 years)
- Adherence to training interventions(2, 4, 7, 10 years)
- Change in 30 s chair stand performance(Baseline, 1, 2, 4, 7, and 10 years)
- Change in whole body composition and bone mineral density as well as lumbar spine and femoral neck bone mineral density(Baseline, 1, 2, 4, 7, and 10 years)
- Changes in brain structure and function(Baseline, 1, 2, 4, 7, and 10 years)
研究者
Michael Kjaer
Professor
Bispebjerg Hospital