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Exercise in Severely Disabled Patients With MS

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Endurance training
Standard care
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Exercise therapy, Aerobic training, Endurance training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MS Hospital in Ry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endurance training

Standard care

Arm Description

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

Outcomes

Primary Outcome Measures

Exercise compliance
Compliance to exercise is registered and serve as the primary outcome.
Drop out rate

Secondary Outcome Measures

Peak oxygen consumption
Measurement of peak oxygen consumption during a ramp protocol on armergometer.
Box and Block test
Sit to stand test
Handgrip test
Wheel-chair test

Full Information

First Posted
November 12, 2012
Last Updated
July 17, 2013
Sponsor
University of Aarhus
Collaborators
The Danish MS Society, Danish MS Hospitals, Haslev and Ry, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01752660
Brief Title
Exercise in Severely Disabled Patients With MS
Official Title
Endurance Training in Severely Disabled Patients With MS - a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish MS Society, Danish MS Hospitals, Haslev and Ry, Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Exercise therapy, Aerobic training, Endurance training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endurance training
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center
Intervention Type
Behavioral
Intervention Name(s)
Endurance training
Intervention Description
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
Intervention Name(s)
Standard care
Intervention Description
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center.
Primary Outcome Measure Information:
Title
Exercise compliance
Description
Compliance to exercise is registered and serve as the primary outcome.
Time Frame
Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention
Title
Drop out rate
Time Frame
Number of participants who drop out is registered at the post measurement just after the intervention.
Secondary Outcome Measure Information:
Title
Peak oxygen consumption
Description
Measurement of peak oxygen consumption during a ramp protocol on armergometer.
Time Frame
1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured
Title
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
Title
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
Title
Handgrip test
Time Frame
1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Dalgas, PhD
Organizational Affiliation
Dep. Public Health, Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MS Hospital in Ry
City
Ry
State/Province
Jylland
ZIP/Postal Code
8680
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24057428
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.
Results Reference
derived

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Exercise in Severely Disabled Patients With MS

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