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Exercise in Severely Disabled Patients With MS

This study has been completed.
Sponsor:
Collaborators:
Sport Science, Institute of Public Health, Aarhus University
The Danish MS Society
The Danish MS Hospitals in Ry and Haslev
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01752660
First received: November 12, 2012
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Multiple Sclerosis
Behavioral: Endurance training
Behavioral: Standard care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Endurance Training in Severely Disabled Patients With MS - a Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Exercise compliance [ Time Frame: Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention ] [ Designated as safety issue: Yes ]
    Compliance to exercise is registered and serve as the primary outcome.

  • Drop out rate [ Time Frame: Number of participants who drop out is registered at the post measurement just after the intervention. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peak oxygen consumption [ Time Frame: 1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured ] [ Designated as safety issue: No ]
    Measurement of peak oxygen consumption during a ramp protocol on armergometer.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Handgrip test [ Time Frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752660

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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01752660     History of Changes
Other Study ID Numbers: UAarhus100
Study First Received: November 12, 2012
Last Updated: July 17, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on November 20, 2014