Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients (ms-intakt)
2016年6月23日 更新者:Prof. Dr. Klaus Pfeifer、University of Erlangen-Nürnberg
In this randomised controlled trial, the feasibility and effectiveness of an internet-based exercise intervention including progressive strength and endurance training (e-training) for PwMS was investigated.
Primary outcome was health-related quality of life, secondary outcomes were muscle strength, aerobic capacity and lung function, physical activity and fatigue.
研究概览
研究类型
介入性
注册 (实际的)
126
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- diagnosed Multiple Sclerosis (McDonald criteria),
- an EDSS score of less than or equal to 4.0,
- not less than 4 weeks of clinical stability prior to inclusion in the study,
- access to the internet.
- the taking of immunotherapeutic agents was not relevant and not monitored
Exclusion Criteria:
- primary progressive multiple sclerosis
- clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:e-training intervention
Resistance and endurance training
|
The e-training intervention is a home-based aerobic and resistance training program.
Resistance training was prescribed twice weekly for a period of 12 weeks.
No special equipment was necessary except an elastic exercise band or a large gymnastic ball.
In addition, endurance training was to be carried out once a week.
Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale.
The form of activity for the endurance training was freely selected, duration (between 10-60 min) was adjusted to individual fitness levels.
Therapists aimed at eliciting a BORG Feedback of between 11 (fairly light) and 16 (hard).
The exercise training was home-based and supervised via the internet.
Participants continued exercise training for another 12 weeks after the 3month assessment.
|
其他:Control
no exercise
|
After the initial assessment on entry, those assigned to the control group were instructed to maintain their previous physical activity behaviour.
After waiting three months, they received the same e-training intervention as the intervention group had received from the start.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)
大体时间:Assessments took place at baseline and at 3 months
|
38 items generate the subscales of fatigue/thinking, mobility of the lower/upper extremities, communication and mood.
The HAQUAMS total score is calculated from a mean of the subscales, providing a total score between 1 and 5. Higher scores in HAQUAMS indicate lower levels in HRQoL.
The primary outcome will be the change over time from baseline to month 3.
|
Assessments took place at baseline and at 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Würzburg Fatigue Scale (WEIMuS)
大体时间:Assessments took place at baseline, at 3 and 6 months
|
This questionnaire contains 17 items that form a physical and cognitive subscale.
The total score ranges from zero to a maximum of 68 points (maximum fatigue).
The cut-off value for the presence of fatigue is above 32.
|
Assessments took place at baseline, at 3 and 6 months
|
Muscle strength lower extremities
大体时间:Assessments took place at baseline and after 3 and 6 months
|
Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).
|
Assessments took place at baseline and after 3 and 6 months
|
Forced vital capacity
大体时间:Assessments took place at baseline and after 3 and 6 months
|
Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
|
Assessments took place at baseline and after 3 and 6 months
|
Aerobic capacity
大体时间:Assessments took place at baseline and after 3 and 6 months
|
As a marker of endurance capacity, maximal oxygen uptake (VO2peak) was determined by the spiroergometry device Master Screen CPX on a bicycle ergometer (Sanabike 250F, MESA, Germany) at 70-80 revolutions per minute.
|
Assessments took place at baseline and after 3 and 6 months
|
Physical activity
大体时间:Assessments took place at baseline and after 3 and 6 months
|
Habitual physical activity was assessed with the German version of the Baecke Questionnaire including three activity indices (work, sport, leisure time PA).
There were limitations concerning content validity in all indices; therefore, the sport score of the sport index was used.
That score is the product of the intensity, duration and frequency of a participant's reported sports activities.
Higher scores indicate a higher level of PA.
|
Assessments took place at baseline and after 3 and 6 months
|
Peak expiratory flow
大体时间:Assessments took place at baseline and after 3 and 6 months
|
Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
|
Assessments took place at baseline and after 3 and 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Matthias Mäurer, Dr.、Caritas-Krankenhaus Bad Mergentheim
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Tallner A, Tzschoppe R,Peters S, Mäurer M, Pfeifer K. Internetgestützte Bewegungsförderung bei Personen mit Multipler Sklerose. Neurologie und Rehabilitation 19(1): 35-46, 2013.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年2月1日
初级完成 (实际的)
2011年6月1日
研究完成 (实际的)
2011年11月1日
研究注册日期
首次提交
2016年5月4日
首先提交符合 QC 标准的
2016年5月10日
首次发布 (估计)
2016年5月13日
研究记录更新
最后更新发布 (估计)
2016年6月24日
上次提交的符合 QC 标准的更新
2016年6月23日
最后验证
2016年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 1.01.1/09/007
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
未定
研究数据/文件
-
Detailed intervention description
信息评论:Detailed description of the processes of the e-training intervention (english language)
-
临床研究报告
信息评论:Final report for funding foundation (german)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
e-training的临床试验
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Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
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RWTH Aachen UniversityClinical Evaluation Research Unit at Kingston General Hospital撤销
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Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完全的
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Association de Recherche Bibliographique pour les...Centre Hospitalier Universitaire de Nice; Centre Hospitalier Princesse Grace完全的
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Oslo Metropolitan UniversityUniversity of Oslo; Nofima; Mills DA完全的