Exercise in Severely Disabled Patients With MS

NCT ID: NCT01752660

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-07-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Endurance training

Intervention Type: BEHAVIORAL

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.

Standard care

Intervention Type: BEHAVIORAL

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

Standard care

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

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Standard care

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Danish MS Society

UNKNOWN

Sponsor Role: collaborator

Danish MS Hospitals, Haslev and Ry

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrik Dalgas, PhD

Role: PRINCIPAL_INVESTIGATOR

Dep. Public Health, Aarhus University

Locations

MS Hospital in Ry

Ry, Jylland, Denmark

Countries

Denmark

References

Skjerbaek AG, Naesby M, Lutzen K, Moller AB, Jensen E, Lamers I, Stenager E, Dalgas U. Endurance training is feasible in severely disabled patients with progressive multiple sclerosis. Mult Scler. 2014 Apr;20(5):627-30. doi: 10.1177/1352458513505351. Epub 2013 Sep 20.

Reference Type: DERIVED

PMID: 24057428 (View on PubMed)

Other Identifiers

UAarhus100

Identifier Type: -

Identifier Source: org_study_id