Clinical trial NCT01752660: Exercise in Severely Disabled Patients With MS
Official title: Endurance Training in Severely Disabled Patients With MS - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Exercise therapy
Aerobic training
Endurance training
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish MS Society
name: Danish MS Hospitals, Haslev and Ry
name: Aarhus University Hospital
First posted: 2012-12-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Exercise compliance
timeFrame: Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention
measure: Drop out rate
timeFrame: Number of participants who drop out is registered at the post measurement just after the intervention.
Secondary outcomes:
measure: Peak oxygen consumption
timeFrame: 1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured
measure: Box and Block test
timeFrame: 1-2 day before the intervention and 1-2days after the 4 week intervention the box and block test is performed
measure: Sit to stand test
timeFrame: 1-2 day before the intervention and 1-2days after the 4 week intervention the sit to stand test is performed
measure: Handgrip test
timeFrame: 1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed
measure: Wheel-chair test
timeFrame: 1-2 day before the intervention and 1-2days after the 4 week intervention the wheel-chair test is performed
Other outcomes:
Locations:
city: Ry
country: Denmark
facility: MS Hospital in Ry
state: Jylland
Study officials:
affiliation: Dep. Public Health, Aarhus University
name: Ulrik Dalgas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.