Resistance Training and Amino Pyridine in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: SR-fampridineDrug: Placebo
- Registration Number
- NCT02143167
- Lead Sponsor
- University of Southern Denmark
- Brief Summary
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.
- Detailed Description
See above
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SR-fampridine/placebo Placebo 24 weeks of SR-fampridine followed by four weeks of inactive placebo. SR-fampridine/placebo SR-fampridine 24 weeks of SR-fampridine followed by four weeks of inactive placebo. Placebo/SR-fampridine SR-fampridine 24 weeks of inactive placebo followed by four weeks of SR-fampridine Placebo/SR-fampridine Placebo 24 weeks of inactive placebo followed by four weeks of SR-fampridine
- Primary Outcome Measures
Name Time Method Muscle power in the lower limbs Muscle power will be measured after 14 weeks of resistance training. Muscle power in the lower limbs is measured by dynamometry pre and post resistance training
- Secondary Outcome Measures
Name Time Method Activity Accelerometry is measured after 14 weeks of resistance training Activity measured by accelerometry.
Walking speed Walking speed is measured after 26 weeks of resistance training Walking speed measured by the Timed 25 Foot Walk (T25FW) and the 6-Minute Walking Test (6MWT)
Walking capacity Walking capacity is measured after 26 weeks of resistance training Walking capacity measured by the Six Spot Step Test (SSST)
Functional capacity in the lower limbs Funcyional capacity in the lower limbs is measured after 26 weeks of resistance training Functional capacity measured by the Chair Stand Test (CST)
Self rated walking capacity Self rated walking capacity is measured after 26 weeks of resistance training Self rated walking capacity measured by the 12-Item Multiple Sclerosis Walking Scale (MSWS12)
Trial Locations
- Locations (4)
Sydvestjysk Sygehus
🇩🇰Esbjerg, Denmark
Sygehus Lillebælt
🇩🇰Vejle, Denmark
Sygehus Sønderjylland
🇩🇰Sønderborg, Denmark
Odense University Hospital
🇩🇰Odense, Denmark