Clinical Trials Directory

Trials / Completed

CompletedNCT03803800

Periodized Rehabilitation and Beta-alanine Supplementation in Multiple Sclerosis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
31 (actual)
Sponsor
Hasselt University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERClassic, progressive endurance trainingModerate intensity endurance training will be performed following a sequence of 5 training sessions every 2 weeks throughout the 12-week intervention. Sessions will include 60min of cycling on a stationary bicycle. Exercise intensity will match 60-80% of the maximal heart rate (HRmax)
OTHERPeriodized exercise trainingThroughout the 12-week periodized intervention, subjects will perform four recurrent 3-week cycles of moderate endurance training (week 1,three sessions, 60min/session, 60-80% HRmax), high intensity interval training (week 2, three sessions, 10min/session, 3x20sec supramaximal sprint interspersed with recovery intervals of 2min), and recovery weeks (week 3, one high intense interval session as described above)
DIETARY_SUPPLEMENTbeta-alanineSome subjects will receive the ergogenic supplement beta-alanine.

Timeline

Start date
2019-01-09
Primary completion
2019-12-01
Completion
2019-12-09
First posted
2019-01-15
Last updated
2020-02-13

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03803800. Inclusion in this directory is not an endorsement.