High Intensity Training and Energy Management Education vs. Standard Training and Muscle Relaxation, to Improve Quality of Life in Persons With Multiple Sclerosis, a Randomized Controlled Superiority Trial With Six Months' Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Short-form 36 (SF-36)
研究概览
简要总结
Persons with Multiple Sclerosis (PwMS) often suffer from impaired mobility and reduced aerobic capacity. Moreover, 65% of PwMS recognize fatigue as their most disabling symptom that quickly impacts patients' health-related quality of life (QoL). Systematic reviews that evaluate therapeutic options for MS-neurorehabilitation show good evidence for exercise and energy management/conservation programs to improve fatigue or its impact on daily life. Guidelines recommend a multidisciplinary approach but to date only unimodal interventions are investigated. This study aims to investigate the influence of the combination of two different therapeutic concepts: inpatient energy management education (IEME) + High-intensity interval training (HIIT). This intervention is compared with a control group that undergoes progressive muscle relaxation (PMR) + low-intensity training (ST). IEME or PMR is performed on two days (tue-thur) and HIIT or ST on three days (mo-wed-fr) / week. The primary outcome is the effect on the quality of life after three weeks rehabilitation and after returning home (at 4 and 6 months follow-up) in PwMS.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite MS diagnosis (revised McDonald criteria, 2018).
- •Age >18y
- •Expanded Disability Status Scale (EDSS) score ≤ 6.5
- •Fatigue Scale of Motor and Cognitive function (FSMC) total score > 43
- •Literacy and understanding German
- •Informed Consent
排除标准
- •Women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Cognitive impairment Mini-Mental State Examination (MMSE) < 21
- •Major Depression or Hospital Anxiety and Depression Scale (HADS) >11 at baseline
- •Stem cell treatment in the last 6 months
- •Participation in a previous high-intensity interval training (HIIT) or inpatient energy management education (IEME) study
结局指标
主要结局
Short-form 36 (SF-36)
时间窗: 6 months (day 0 - day 183) with time points set after three weeks (day 21) and 4 months (day 122).
Changes of health-related quality of life will be assessed with the SF-36. The SF-36 questionnaire comprises 36 items. Scores range from 0 to 100 with higher values indicating better QoL.
次要结局
- Fatigue Scale of motor and cognitive function (FSMC)(Six months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).)
- Hospital Anxiety and Depression Scale (HADS)(6 months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).)
- Indicators of inflammatory activity(Three weeks (day 0 - day 21).)
- Cardiorespiratory Fitness(Three weeks (day 0 - day 21).)
- Self-efficacy in performing energy conservation strategies (SEPECSA)(Six months (day 0 - day 183) with time points set after three weeks (day 21) and after 4 months (day 122).)
- Self-perceived competence in activities of daily living (OSA)(Six months (day 0 - day 21) with time points set after three weeks (day 21) and four months (day 122).)
研究者
Jens Bansi
Principal Investigator Research and Deveopment and Sport Scientist
Klinik Valens