Exercise in Severely Disabled Patients With MS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752660
• Other study ID #: UAarhus100
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2012
• Last updated: July 17, 2013
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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.
• Standard care
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center.

Locations

Country	Name	City	State
Denmark	MS Hospital in Ry	Ry	Jylland

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Danish MS Hospitals, Haslev and Ry, The Danish MS Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Drop out rate		Number of participants who drop out is registered at the post measurement just after the intervention.	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Handgrip test		1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed	No
Secondary	Wheel-chair test		1-2 day before the intervention and 1-2days after the 4 week intervention the wheel-chair test is performed	No