High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incremental test
研究概览
简要总结
We want investigate if high intensity training can increase daily functionality without causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if there is a difference in effect with supervised and unsupervised training. Furthermore we want to study if a supervised training program will motivate participants to continue training by the end of the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with Spinal and bulbar muscular atrophy or
- •Healthy control subjects matched individually with participating patients on age, sex, BMI and activity level.
排除标准
- •More than 1 hour of fitness weekly before inclusion
- •Other disease possibly confounding the results
- •Pregnancy or breastfeeding
- •Participations in other scientific studies wich could influence on the results during the last 30 days before inclusion.
- •Physical and/or mental conditions preventing participating in the study protocol.
研究组 & 干预措施
Supervised high intensity training
8 weeks of supervised high intensity training, 10 minutes, 3 times a week (once a week supervised) on a cycle ergometer followed by 8 weeks of unsupervised optional training.
Participants: Patients with Kennedy's disease or healthy control subjects (individually matched with patients).
Participants: Patients with Kennedys disease and healthy control subjects.
干预措施: Supervised high intensity training (Other)
Supervised high intensity training
8 weeks of supervised high intensity training, 10 minutes, 3 times a week (once a week supervised) on a cycle ergometer followed by 8 weeks of unsupervised optional training.
Participants: Patients with Kennedy's disease or healthy control subjects (individually matched with patients).
Participants: Patients with Kennedys disease and healthy control subjects.
干预措施: Optional training (Other)
Unsupervised High intensity training
8 week control period with no training followed by 8 weeks of unsupervised high intensity training on a cycle ergometer.
Participants: Patients with Kennedy's disease.
干预措施: Control period (Other)
Unsupervised High intensity training
8 week control period with no training followed by 8 weeks of unsupervised high intensity training on a cycle ergometer.
Participants: Patients with Kennedy's disease.
干预措施: Unsupervised High intensity training (Other)
结局指标
主要结局
Incremental test
时间窗: Baseline, week 6, week 11, week 18
Primary outcome is changes from baseline in maximal oxygen consumption and maximal workload after a 8 week supervised training program followed by a 8 week non-supervised optional training period. during and after 8 weeks of High Intensity Training on a cycle ergometer. The outcome is measured by an incremental test on a cycle ergometer.
次要结局
- Functional test(Baseline, week 6, week 11, week 18.)
- Self-rated muscle fatigue, muscle pain and activity level(Every day in week 1-11)
- Serum concentrations of Creatine Kinase (CK)(Baseline, Week 3,4,5,6,7,8,9,10,11, week 18.)
- Activity level(Baseline, week 10 and week 18.)
研究者
Karen Brorup Heje Pedersen
Bachelor in medicine
Rigshospitalet, Denmark