Effect and Feasibility of Non-linear Periodized Resistance Training in People With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Change from baseline dynamic maximal endurance at week 9
研究概览
简要总结
This study aims at improving the knowledge about resistance training for people with COPD. Resistance training is an important part of pulmonary rehabilitation when the goal is to improve muscular endurance and strength. The study will evaluate the effects and the feasibility of two resistance training programs for people with COPD using a parallel group design. One program will include a larger day-to-day variation (i.e. non-linear periodization) and the progression will be guided by ratings of dyspnea, muscle fatigue, and exertion. The other program will follow the established guidelines for resistance training for people with COPD. The programs will be evaluated for effects regarding muscular endurance, strength, intramuscular adaptions, functional preformance, dyspnea, and health related quality of life. The programs will also be evaluated for feasibility regarding the duration of training sessions, attendance rates, adverse events, and participant satisfaction. The hypothesis is that the non-linear periodization group will have superior effects and that feasibility aspects will be similar between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessors will be masked to group allocation. The participants will be given repeated instructions not to reveal their group allocation to the outcome assessors. In case of failure in keeping the outcome assessor masked (i.e, a patient reveals his/her group allocation), a second trained outcome assessor will be available.
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1/FVC ratio < 70% postbronchodilator
- •FEV1 <80% of the predicted normal value postbronchodilator
排除标准
- •Clinical evidence of asthma, cardiovascular diseases, and/or neuromuscular diseases that are unstable and/or that may contribute to exercise limitation
- •Other contraindications to exercise
- •Currently participating in a structured exercise or pulmonary rehabilitation program or been involved in pulmonary rehabilitation in the past 6 months
- •Experienced a COPD exacerbation and/or change in medication dosage/frequency in the past 6 weeks
结局指标
主要结局
Change from baseline dynamic maximal endurance at week 9
时间窗: Baseline and week 9
Maximal limb muscle endurance measured using resistance training machines or free weights. Reported as the number of repetitions at 45% of the baseline one repetition maximum.
Change from baseline dynamic maximal strength at week 9
时间窗: Baseline and week 9
Maximal limb muscle strength measured using resistance training machines or free weights. Reported as one repetition max in kg.
次要结局
- Change from baseline 60 seconds sit to stand test (60STS) at week 9(Baseline and week 9)
- Attendance rate(Week 1 up to 8)
- Duration of exercise sessions(Week 1 up to 8)
- Change from baseline capillarization (capillaries to fiber) at week 9(Baseline and week 9)
- Change from baseline static maximal strength at week 9(Baseline and week 9)
- Adverse Events rate(Week 1 up to 8)
- Change from baseline glycolytic (lactate dehydrogenase (LDH), EC 1.1.1.27) enzyme activities at week 9(Baseline and week 9)
- Change from baseline endurance shuttle walk test (ESWT) at week 9(Baseline and week 9)
- Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) dyspnea Domain Scores at week 9(Baseline and week 9)
- Change from baseline static maximal endurance at week 9(Baseline and week 9)
- Change from baseline unsupported upper limb test (UULEX) at week 9(Baseline and week 9)
- Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Total Scores at week 9(Baseline and week 9)
- Number of responders(Week 9)
- Proportion of drop-outs(Week 9)
- Adverse Events stratified by severity(Week 1 up to 8)
- Change from baseline proportion of slow and fast subtypes of contractile myosin heavy chain isoforms in fibers at week 9(Baseline and week 9)
- Satisfaction rate(Week 9)
- Change from baseline muscle fiber size at week 9(Baseline and week 9)
- Change from baseline oxidative (citrate synthase (CS), EC 4.1.3.7) enzyme activities at week 9(Baseline and week 9)
- Change from baseline capillarization (capillary density) at week 9(Baseline and week 9)
- Change from baseline capillarization (capillaries relative to fiber area) at week 9(Baseline and week 9)