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Completed

NCT Number: NCT01752660

Exercise in Severely Disabled Patients With MS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MS Hospital in Ry

Ry, Jylland, 8680, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endurance training

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

Behavioral

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

Primary outcomes

  1. Exercise compliance

    Time frame: Exercise 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.

  2. Drop out rate

    Time frame: Number of participants who drop out is registered at the post measurement just after the intervention.

Secondary outcomes

  1. Peak oxygen consumption

    Time frame: 1-2 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.

  2. 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

  3. 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

  4. Handgrip test

    Time frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed

  5. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Danish MS Hospitals, Haslev and Ry
  • The Danish MS Society

Registry information

Official study title

Endurance Training in Severely Disabled Patients With MS - a Feasibility Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 19, 2012
Registry last updated
Jul 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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