Clinical trial NCT03803800: Periodized Rehabilitation and Beta-alanine Supplementation in Multiple Sclerosis
Official title: Periodized Rehabilitation and Beta-alanine Supplementation in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Rehabilitation
Periodized exercise therapy
Ergogenic supplementation
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four intervention groups following either 12 weeks of 'classical' moderate intensity cardiovascular exercise therapy (n=40) or periodized exercise therapy (n=40), with (MSβclassic, n=20; MSβperiod, n=20) or without (MSclassic, n=20; MSperiod, n=20) β-alanine supplementation
Primary purpose: OTHER

Brief summary: Exercise therapy and increased physical activity in persons with Multiple Sclerosis (MS) improves mobility, muscular strength, physical fitness and fatigue without increasing relapse rate. As such, physical activity and more particular exercise therapy have become an important part of MS rehabilitation. Despite the fact that the positive effects of exercise therapy in MS are obvious only 43 percent of the MS community reports to participate in an exercise program4. Therefore, new exercise therapy approaches that further optimize rehabilitation, improve exercise adherence and promote participation in physical exercise in MS are interesting to explore. Therefore, the randomized controlled trial investigates two types of exercise interventions (classic progressive vs periodized) with or without the addition of ergogenic supplements (beta-alanine vs placebo).

Detailed description: Following inclusion, baseline measurements (PRE) will be performed in MS patients (n=80). First, static(isometric) muscle strength (dynamometry), exercise capacity (maximal graded exercise test) and body composition (DEXA) will be evaluated. After 4 days of recovery, m. vastus lateralis muscle samples (Bergström procedure) will be taken. Hereafter, MS patients will be randomly allocated to one of four intervention groups following either 12 weeks of 'classical' moderate intensity cardiovascular exercise therapy (n=40) or periodized exercise therapy (n=40), with (MSβclassic, n=20; MSβperiod, n=20) or without (MSclassic, n=20; MSperiod, n=20) β-alanine supplementation. Groups not receiving β-alanine supplements, will receive placebo tablets that will be identical in taste and appearance. To evaluate post training fatigue, perceived exertion will be recorded following each training session (6-20 BORG scale). Following 12 weeks of classic or periodized training POST intervention measurements will be performed similar to baseline.

Eligibility criteria: Inclusion criteria:

* Diagnosis Multiple Sclerosis.
* Healthy control.
* Aged \>18y.
* Written informed consent.

Exclusion criteria:

* Contraindications to perform moderate to high intensity exercise.
* Participation in another study.
* Experienced acute MS related exacerbation \<6 months prior to start of the study
* EDSS score \> 6

Primary outcomes:
measure: Exercise capacity
timeFrame: 3 weeks
measure: Serum lactate
timeFrame: 3 weeks
measure: Body composition
timeFrame: 3 weeks
measure: Body mass index
timeFrame: 3 weeks
measure: Strength measurement
timeFrame: 3 weeks
measure: Muscle carnosine concentration
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: University Hasselt
name: Bert O Eijnde
role: PRINCIPAL_INVESTIGATOR
References: