Exercise in Severely Disabled Patients With MS

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Endurance training; Behavioral: Standard care

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Jylland
    • Ry, Jylland, Denmark, 8680
      • MS Hospital in Ry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise compliance	Compliance to exercise is registered and serve as the primary outcome.	Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention
Drop out rate		Number of participants who drop out is registered at the post measurement just after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen consumption	Measurement of peak oxygen consumption during a ramp protocol on armergometer.	1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured
Box and Block test		1-2 day before the intervention and 1-2days after the 4 week intervention the box and block test is performed
Sit to stand test		1-2 day before the intervention and 1-2days after the 4 week intervention the sit to stand test is performed
Handgrip test		1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed
Wheel-chair test		1-2 day before the intervention and 1-2days after the 4 week intervention the wheel-chair test is performed

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Danish MS Hospitals, Haslev and Ry; The Danish MS Society
• Investigators: Principal Investigator: Ulrik Dalgas, PhD, Dep. Public Health, Aarhus University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: November 12, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Estimate): July 18, 2013
• Last Update Submitted That Met QC Criteria: July 17, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Aerobic training; Exercise therapy; Endurance training
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: UAarhus100