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Exercise in Severely Disabled Patients With MS

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ClinicalTrials.gov Identifier: NCT01752660
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : July 18, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Endurance training Behavioral: Standard care Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Endurance Training in Severely Disabled Patients With MS - a Feasibility Study
Study Start Date : October 2012
Primary Completion Date : February 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752660


Locations
Denmark
MS Hospital in Ry
Ry, Jylland, Denmark, 8680
Sponsors and Collaborators
University of Aarhus
The Danish MS Society
Danish MS Hospitals, Haslev and Ry
Aarhus University Hospital
Investigators
Principal Investigator: Ulrik Dalgas, PhD Dep. Public Health, Aarhus University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01752660     History of Changes
Other Study ID Numbers: UAarhus100
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013

Keywords provided by University of Aarhus:
Exercise therapy
Aerobic training
Endurance training

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases