MedPath

Exercise in Severely Disabled Patients With MS

Phase 1
Completed
Conditions
Multiple Sclerosis
Interventions
Behavioral: Endurance training
Behavioral: Standard care
Registration Number
NCT01752660
Lead Sponsor
University of Aarhus
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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

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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Endurance trainingEndurance trainingStandard 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.
Endurance trainingStandard careStandard 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.
Standard careStandard careStandard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center
Primary Outcome Measures
NameTimeMethod
Exercise complianceExercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention

Compliance to exercise is registered and serve as the primary outcome.

Drop out rateNumber of participants who drop out is registered at the post measurement just after the intervention.
Secondary Outcome Measures
NameTimeMethod
Peak oxygen consumption1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured

Measurement of peak oxygen consumption during a ramp protocol on armergometer.

Box and Block test1-2 day before the intervention and 1-2days after the 4 week intervention the box and block test is performed
Sit to stand test1-2 day before the intervention and 1-2days after the 4 week intervention the sit to stand test is performed
Handgrip test1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed
Wheel-chair test1-2 day before the intervention and 1-2days after the 4 week intervention the wheel-chair test is performed

Trial Locations

Locations (1)

MS Hospital in Ry

🇩🇰

Ry, Jylland, Denmark

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