Resistance Training and Amino Pyridine in Multiple Sclerosis

University of Southern Denmark40 enrolled

Overview

Prolonged-release fampridine (SR-fampridine) can improving walking capacity in approximately 40% of MS patients suffering from this by overcoming partly or total conduction block due to demyelination. Resistance training has been shown to provide the same kind of benefits for patients by targeting the muscular component of the motor unit. Thus by combining the two it is likely to see an synergistic effect. This trial is designed as a double blind, randomized placebo controlled trial with subsequent cross-over. Participants in the two arms will go through the same progressive training program targets at the lower limbs. For 24 weeks one group receives SR-fampridine and the other receives placebo. in the the end there is another four weeks of training after cross-over has been performed.

See above

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria * Expandend Disability Status Scale (EDSS) 3-6.5 * Pyramidal Functional Score ≥ 2 * Participants must be able to transport self to gym and to the University of Southern Denmark * Participants must be able to complete T25FW and SSST * Fertile female participants are obliged to use hormonal contraceptive measures Exclusion Criteria: * History of epileptic seizures * MS relapse or change in disease modifying treatment (DMT) within 60 days * Cancer within five years * Blood pressure ≥ 160/100 * Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation * ≥ ALT 90 U/l, ≥ BSP 210 U/l, ≥ γ-GT 230 U/l * GFR \< 80 ml/min. * History of severe pulmonary disease or unexplained abnormal pulmonary auscultation * Pregnancy * Breastfeeding * Allergy to substances contained in prolonged release Fampridine tablets * Concomitant treatment with carvedilol, propranolol or metformin.

Locations (4)

Sydvestjysk Sygehus

Esbjerg, Denmark

Odense University Hospital

Odense, Denmark

Sygehus Sønderjylland

Sønderborg, Denmark

Sygehus Lillebælt

Vejle, Denmark

Outcomes

Primary Outcomes

Muscle power in the lower limbs

Muscle power in the lower limbs is measured by dynamometry pre and post resistance training

Time frame: Muscle power will be measured after 14 weeks of resistance training.

Secondary Outcomes

Activity

Activity measured by accelerometry.

Time frame: Accelerometry is measured after 14 weeks of resistance training

Walking capacity

Walking capacity measured by the Six Spot Step Test (SSST)

Time frame: Walking capacity is measured after 26 weeks of resistance training

Walking speed

Walking speed measured by the Timed 25 Foot Walk (T25FW) and the 6-Minute Walking Test (6MWT)

Time frame: Walking speed is measured after 26 weeks of resistance training

Functional capacity in the lower limbs

Functional capacity measured by the Chair Stand Test (CST)

Time frame: Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training

Self rated walking capacity

Self rated walking capacity measured by the 12-Item Multiple Sclerosis Walking Scale (MSWS12)

Time frame: Self rated walking capacity is measured after 26 weeks of resistance training