Exercise in Severely Disabled Patients With MS

NCT01752660 | Completed Phase 1

• 1 other identifier: UAarhus100
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Exercise therapy; Aerobic training; Endurance training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Peak oxygen consumption

  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

Study Arms (2)

Endurance training

EXPERIMENTAL

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; Behavioral: Standard care

Standard care

ACTIVE COMPARATOR

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

Behavioral: Standard care

Interventions

Endurance training BEHAVIORAL

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.

Endurance training

Standard care BEHAVIORAL

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

Endurance training; Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• \>18 years
• Primary progressive or secondary progressive MS according to the McDonald criteria
• ≤ EDSS ≤ 8.0 and pyramidal score between 1 and 4
• Maximal walking distance ≤ 10m

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish MS Society: collaborator
• Danish MS Hospitals, Haslev and Ry: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

MS Hospital in Ry

Ry, Jylland, 8680, Denmark

Location

Related Publications (1)

• 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.

  PMID: 24057428 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Endurance Training; Standard of Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ulrik Dalgas, PhD

  Dep. Public Health, Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: December 19, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

DK (1)