Effect of Strength Training and Protein Ingestion in Old Versus Very-old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in muscle cross sectional area
研究概览
简要总结
From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely:
HRTW: Heavy Strength Training x3/week & 20g whey protein twice daily. LITW: Light Intensity Training x3-5/week & 20g whey protein twice daily. WHEY: 20g whey protein twice daily.
15 subjects from each group will be recruited and tested after 3 months of intervention. Tests will include muscle cross sectional area (MRi), muscle biopsies (fiber types, size, cell- and capillary count), functional- and strength measurements, plasma lipids, HbA1c. Tests are to be compared with Project ID NCT01997320.
详细描述
In- and exclusion criteria are listed in NCT02034760. Subjects will be randomized to interventions as described, and 15 subjects from each of the three groups will be tested after 12 weeks of intervention.
15 subjects are included in each group to account for an expected drop-out rate of 20%, and so 12 subjects are expected to complete each intervention. With this N an increase of around 11% in MRi-evaluated muscle size can be detected with a powerlevel of 80% and an alpha of 0.05 and use of reported SD.
Primary outcome is muscle size (MRi), and secondary outcomes are overall body composition (DXA), muscle strength, rate of force development, power, 30s chair stand, 400m gait speed, grip strength. Tertiary outcomes are habitual activitylevel (accelerometry), blood samples (HbA1c, cholesterols, creatinine), blood pressure, weight, BMI, wast- and hip circumference.
Results are to be compared with NCT01997320 and so a population of 65+ can be compared with a population of 83+. Both studies uses the same heavy strength training regimen.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, independently living
- •Age at least 65 years
排除标准
- •Subjects dependent on help/nursing etc.
- •Chronic medical diseases: Diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia.
- •Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens.
- •Implanted magnetic devices incompatible with MRi-scanning.
- •Weekly alcohol consumption > 21 units (1 unit equals 4g of ethanol) for men and > 14 for women.
- •Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ACE-inhibitors, Angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing diuretics and loop diuretics.
- •>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
Light Intensity Training
Home-based Light Intensity Training of the lower extremities three-five times weekly in combination with two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.
干预措施: Light Intensity Training (Procedure)
Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.
干预措施: Protein Whey (Procedure)
Heavy Resistance Training
Heavy Resistance Training of the lower extremities three times weekly in combination with two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.
干预措施: Heavy Resistance Training (Procedure)
结局指标
主要结局
Change in muscle cross sectional area
时间窗: Baseline, 3 months
MRi scans of quadriceps muscle cross sectional area. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing groups: 1) Heavy Resistance Training vs. Light Intensity Training vs. Protein Whey. The statistical evaluation will be performed first as an intension-to-treat analysis and subsequently as a per-protocol analysis.
次要结局
- Change in leg extension muscle power(Baseline, 3 months)
- Change from baseline in muscle structure and signalling(Baseline and 3 months)
- Change in 30 s chair stand(Baseline, 3 months)
- Change in whole body composition and bone mineral density(Baseline, 3 months)
- Change in quadriceps muscle isokinetic strength(Baseline, 3 months)
- Change in quadriceps muscle isometric strength(Baseline, 3 months)
研究者
Lars Holm
Ph.D. M.S.
Bispebjerg Hospital