A 6-month, Multicenter, Randomized, Controlled Parallel Group Study to Evaluate the Effect of Physical Training on Fatigue in Patients With Relapsing-remitting Multiple Sclerosis Treated With Fingolimod, Followed by a 6 Month Optional Extension Phase
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 178
- 试验地点
- 32
- 主要终点
- Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).
研究概览
简要总结
This study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients.
详细描述
In this study, it was planned to randomize 226 participants. However, only 178 participants were randomized during a timeframe of 2 years and 8 months. Therefore, the study was terminated due to slow enrollment and low participant compliance to the physical training schedule.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
- •Patients with Expanded Disability Status Scale (EDSS) score of 0-3.5 (including)
- •Immunomodulatory treatment with prescribed fingolimod for at least one month prior to baseline
- •Fatigue score assessed by mFIS of equal or greater than 14 at screening
- •Neurologically stable with no evidence of relapse within 30 days prior to inclusion date
排除标准
- •Patients who have been treated with:
- •systemic corticosteroids or immunoglobulins within 1 month prior to randomization;
- •immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months prior to randomization;
- •monoclonal antibodies (including natalizumab) within 3 months prior to randomization;
- •mitoxantrone within 6 months prior to randomization
- •cladribine at any time.
- •Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
- •Patients with any of the following cardiovascular conditions :
- •history of cardiac arrest;
- •history of myocardial infarction or with current unstable ischemic heart disease;
- •history of angina pectoris due to coronary spasm or history of Raynaud syndrome
- •Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the investigator;
- •history or presence of a second-degree AV block, Type II or a third-degree AV
- •patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or
- •III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide,
- •dofelitide);
- •proven history of sick sinus syndrome or sino-atrial heart block;
- •uncontrolled hypertension
- •Clinically relevant internal disease (e.g. uncorrected anemia) or orthopedic diseases (e.g. scoliosis) that might interfere with physical training
- •Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
E-training
Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
干预措施: Physical exercise (Other)
Waiting
Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 months waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
干预措施: Physical exercise (Other)
结局指标
主要结局
Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).
时间窗: Baseline, 6 months
The mFIS provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. It is a 21-item, structured, self-report questionnaire that generally can be completed with little or no intervention from an interviewer. The mFIS score ranged from 0 (not tired) to 84 (tired). A negative change from baseline indicates improvement.
次要结局
- Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Sit-to-stand Test(baseline, 6 months)
- Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Change in Leg Strength and Trunk Strength(baseline, 6 months)
- Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Leg Strength Endurance(baseline, 6 months)
- Change From Baseline in Fatigue as Measured by the WEIMuS (Würzburg Fatigue Inventory for MS)(Baseline, 6 months)
- Change From Baseline in Depression as Measured by the Beck Depression Inventory Second Edition (BDI-II)(Baseline, 6 months)
- Change From Baseline in Aerobic Capacity (VO2max) as Measured by a Physical Endurance Spiroergometry on a Treadmill(Baseline, 6 months)
- Change From Baseline in Peak Expiratory Flow as Measured by a Physical Endurance Spiroergometry on a Treadmill(Baseline, 6 months)
- Change From Baseline in Quality of Life as Measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)(Baseline, 6 months, 12 months)