Clinical trial NCT00381576: Multiple Sclerosis and Heavy Progressive Resistance Training
Official title: Multiple Sclerosis and Muscle Function - Effects of Heavy Progressive Resistance Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Resistance training
Strength training
Training adaptations
CNS
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Sonderborg Hospital
name: The Danish Multiple Sclerosis Society
First posted: 2006-09-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the present investigation is to determine whether MS patients can tolerate and benefit from heavy progressive resistance training. A second purpose is to determine both neural and muscle morphological adaptations to heavy progressive resistance training.

Detailed description: Multiple sclerosis (MS) patients are characterized by reduced muscle strength and functional capacity. For MS patients, improvements in muscle strength and thereby functional capacity, would have the potential to make both the daily living easier and to extend the time living independently. Attempts to improve muscle strength and function include the application of physical training, although the general advice to MS patients for many years has been to avoid participation in physical training. It has now been demonstrated that endurance training at low to moderate intensity is well tolerated by MS patients, but it only induces modest improvements in both muscle strength and functional capacity. Heavy progressive resistance training (HPRT) has proven to be the most effective means to improve muscle strength and functional capacity during daily activities in healthy older people. However, the effects of HPRT have not been investigated in randomised control trials in MS patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Relapsing Remitting Multiple Sclerosis according to the McDonald criteria
* Expanded Disability Status Scale Score between 3,0-5,5
* Be able to walk at least 100m
* Be able to train twice a week at the University

Exclusion Criteria:

* Alcohol abuse, Alzheimer's and pacemaker
* Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases
* Having had an attack in a period of 8 weeks prior to the start of the intervention period
* Having an attack during the intervention period
* Pregnancy
* Systematic resistance training in a period of 3 months prior to the start of the intervention period.
* Training adherence of less than 85%.

Primary outcomes:
measure: Muscle strength (isokinetic testing)
timeFrame: Before and after the intervention
Secondary outcomes:
measure: Functional capacity (Six minute walk test, 10m walk test, chair rise, stair climbing)
timeFrame: Before and after the intervention
measure: Muscle biopsies from m. vastus lateralis
timeFrame: Before and after the intervention
measure: % Fat (skinfold)
timeFrame: Before and after the intervention
measure: Blood samples (immunologic parameters)
timeFrame: Before and after the intervention
measure: Fatigue (Fatigue Severity Scale - FSS, Modified Fatigue Inventory - MFI-20)
timeFrame: Before and after the intervention
measure: HRQOL: SF36
timeFrame: Before and after the intervention
measure: Depression: Major Depression Inventory (MDI)
timeFrame: Before and after the intervention
measure: Surface EMG from m. vastus lateralis during MVC
timeFrame: Before and after the intervention
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: MS Clinic, Department of Neurology, Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Department of Sports Science, University of Aarhus
Study officials:
affiliation: Department of Sports Science, University of Aarhus
name: Ulrik Dalgas, Ph.d. Stud.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Sports Science, University of Aarhus
name: Thorsten Ingemann-Hansen, Professor
role: STUDY_CHAIR
affiliation: MS clinic, Department of Neurology, Sonderborg Hospital
name: Egon Stenager, MD
role: STUDY_CHAIR
References:
citation: Dalgas U, Stenager E, Lund C, Rasmussen C, Petersen T, Sorensen H, Ingemann-Hansen T, Overgaard K. Neural drive increases following resistance training in patients with multiple sclerosis. J Neurol. 2013 Jul;260(7):1822-32. doi: 10.1007/s00415-013-6884-4. Epub 2013 Mar 13.
citation: Dalgas U, Severinsen K, Overgaard K. Relations between 6 minute walking distance and 10 meter walking speed in patients with multiple sclerosis and stroke. Arch Phys Med Rehabil. 2012 Jul;93(7):1167-72. doi: 10.1016/j.apmr.2012.02.026. Epub 2012 Mar 12.