Exercise in Severely Disabled Patients With MS
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Purpose
In the last decade physical exercise has become an accepted and integrated part of rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated whether the most severely disabled patients can tolerate and benefit from exercise therapy. The purpose of this study is therefore to evaluate the feasibility of endurance training in severely disabled patients with MS.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Behavioral: Endurance training Behavioral: Standard care |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Endurance Training in Severely Disabled Patients With MS - a Feasibility Study |
- Exercise compliance [ Time Frame: Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention ] [ Designated as safety issue: Yes ]Compliance to exercise is registered and serve as the primary outcome.
- Drop out rate [ Time Frame: Number of participants who drop out is registered at the post measurement just after the intervention. ] [ Designated as safety issue: Yes ]
- Peak oxygen consumption [ Time Frame: 1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured ] [ Designated as safety issue: No ]Measurement of peak oxygen consumption during a ramp protocol on armergometer.
- Box and Block test [ Time Frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the box and block test is performed ] [ Designated as safety issue: No ]
- Sit to stand test [ Time Frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the sit to stand test is performed ] [ Designated as safety issue: No ]
- Handgrip test [ Time Frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed ] [ Designated as safety issue: No ]
- Wheel-chair test [ Time Frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the wheel-chair test is performed ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Endurance training
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity.
|
Behavioral: Endurance training
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity.
Behavioral: Standard care
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center.
|
|
Active Comparator: Standard care
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center
|
Behavioral: Standard care
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center.
|
Detailed Description:
For many years, patients with multiple sclerosis (MS) have been advised not to participate in physical exercise. This advice was given in part because some patients were reported to experience symptom instability during exercise as a consequence of increased body temperature. A further argument was that avoiding exercise would preserve energy and thereby result in less fatigue, leaving more energy for activities of daily living. During the last decade, it has been more common to recommend exercise for MS patients, because of its recently proven beneficial effects in these patients.
Resistance- and endurance training constitutes the two extremes of basic physical exercise. To gain insight into the effects of exercise it therefore makes sense to understand the extremes. In mild to moderately impaired MS patients endurance training is well tolerated and providing beneficial effects. However, this exercise modality has not yet been tested in severely disabled patients, and it is therefore unclear if endurance training is feasible and beneficial in these patients. The investigators have, therefore, designed a feasibility study evaluating the effects of 4 weeks of endurance training in severely disabled MS patients (Expanded Disability Status Scale score > 6).
Patients are inpatients at one of the national MS hospitals and endurance training is added to the usual care, and compared to usual care only (control group). Exercise frequency is 3 times per week, and intensity is controlled by HR measurements during exercise.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Signed informed consent
->18 years
- Primary progressive or secondary progressive MS according to the McDonald criteria
- 6.5 ≤ EDSS ≤ 8.0 and pyramidal score between 1 and 4
- Maximal walking distance ≤ 10m
Exclusion Criteria:
- Patients are excluded if they:
- have dementia,alcoholism, or pacemaker treatment
- any serious medical comorbidities
- are pregnant
- have done systematic endurance training (>1day/week) within the last 3 months.
- complete less than 80% of the planned training sessions
- medical conditions that exclude performance of a maximal endurance test.
Contacts and Locations| Contact: Ulrik Dalgas, PhD | +4540123039 | dalgas@sport.au.dk |
| Denmark | |
| MS Hospital in Ry | Recruiting |
| Ry, Jylland, Denmark, 8680 | |
| Contact: Ulrik Dalgas, PhD +4540123039 dalgas@sport.au.dk | |
| Sub-Investigator: Ellen Jensen, PT | |
| Principal Investigator: | Ulrik Dalgas, PhD | Dep. Public Health, Aarhus University |
More Information
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01752660 History of Changes |
| Other Study ID Numbers: | UAarhus100 |
| Study First Received: | November 12, 2012 |
| Last Updated: | December 14, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by University of Aarhus:
|
Exercise therapy Aerobic training Endurance training |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013