Exercise in Severely Disabled Patients With MS

University of Aarhus

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Behavioral: Standard care; Behavioral: Endurance training

Study type: Interventional

Funder types: Other

Identifiers

NCT01752660

UAarhus100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Endurance training

Experimental group

Description:

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.

Treatment:

Behavioral: Endurance training

Behavioral: Standard care

Standard care

Active Comparator group

Description:

Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center

Treatment:

Behavioral: Standard care