Periodized Rehabilitation and Beta-alanine Supplementation in Multiple Sclerosis

NCT ID: NCT03803800

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2019-12-09

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Classic training & beta-alanine

Subjects following 12 weeks of classic, progressive endurance training, with the addition of ergogenic supplements (beta-alanine supplementation).

Group Type: EXPERIMENTAL

Classic, progressive endurance training

Intervention Type: OTHER

Moderate 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)

beta-alanine

Intervention Type: DIETARY_SUPPLEMENT

Some subjects will receive the ergogenic supplement beta-alanine.

Classic training & placebo

Subjects following 12 weeks of classic, progressive endurance training, without the addition of ergogenic supplements (placebo supplements).

Group Type: PLACEBO_COMPARATOR

Classic, progressive endurance training

Intervention Type: OTHER

Moderate 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)

Periodized training & beta-alanine

Subjects following 12 weeks of periodized exercise training, with the addition of ergogenic supplements (beta-alanine supplementation).

Group Type: EXPERIMENTAL

Periodized exercise training

Intervention Type: OTHER

Throughout 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)

beta-alanine

Intervention Type: DIETARY_SUPPLEMENT

Some subjects will receive the ergogenic supplement beta-alanine.

Periodized training & placebo

Subjects following 12 weeks of periodized exercise training, without the addition of ergogenic supplements (placebo supplements).

Group Type: PLACEBO_COMPARATOR

Periodized exercise training

Intervention Type: OTHER

Throughout 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)

Interventions

Classic, progressive endurance training

Moderate 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)

Intervention Type: OTHER

Periodized exercise training

Throughout 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)

Intervention Type: OTHER

beta-alanine

Some subjects will receive the ergogenic supplement beta-alanine.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Bert Op't Eijnde

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bert O Eijnde

Role: PRINCIPAL_INVESTIGATOR

University Hasselt

Locations

Hasselt University

Diepenbeek, Limburg, Belgium

Countries

Belgium

Other Identifiers

16.111/REVA16.14

Identifier Type: -

Identifier Source: org_study_id