Periodized Rehabilitation and Beta-alanine Supplementation in Multiple Sclerosis (MSCAR)

February 12, 2020 updated by: Bert Op't Eijnde, Hasselt University
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Diepenbeek, Limburg, Belgium, 3590
        • Hasselt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Classic training & beta-alanine
Subjects following 12 weeks of classic, progressive endurance training, with the addition of ergogenic supplements (beta-alanine supplementation).
Other: 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)
Dietary supplement: beta-alanine
Some subjects will receive the ergogenic supplement beta-alanine.
Placebo Comparator: Classic training & placebo
Subjects following 12 weeks of classic, progressive endurance training, without the addition of ergogenic supplements (placebo supplements).
Other: 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)
Experimental: Periodized training & beta-alanine
Subjects following 12 weeks of periodized exercise training, with the addition of ergogenic supplements (beta-alanine supplementation).
Dietary supplement: beta-alanine
Some subjects will receive the ergogenic supplement beta-alanine.
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)
Placebo Comparator: Periodized training & placebo
Subjects following 12 weeks of periodized exercise training, without the addition of ergogenic supplements (placebo supplements).
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exercise capacity
Time Frame: 3 weeks
Exercise capacity will be assessed using a maximal (12-lead ECG) graded cardiopulmonary exercise test (♂: 30W+15W/min, ♀: 20W+10W/min, GE eBike Basic®) with pulmonary gas exchange analysis (Jaeger Oxycon®). VO2, VE, RER will be monitored. This test will be performed at least 48 hours separated from the muscle strength test, to prevent interference of muscle fatigue. RER values will be evaluated to verify if the test was performed maximally (RER >1.1).
3 weeks
Serum lactate
Time Frame: 3 weeks
During the exercise test, 2min capillary blood samples will be obtained to analyse blood lactate concentrations (Analox®) and determine the anaerobic threshold before, during and after exercise.
3 weeks
Body composition
Time Frame: 3 weeks
hole body fat and lean tissue mass will be obtained using Dual Energy X-ray Absorptiometry scan (DEXA) (Hologic Series Delphi-A Fan Beam X-ray Bone Densitometer, Vilvoorde, Belgium).
3 weeks
Body mass index
Time Frame: 3 weeks
Weight (calibrated analogue weight scale) and height will be combined to report BMI in kg/m^2.
3 weeks
Strength measurement
Time Frame: 3 weeks
Quadriceps and hamstrings muscle strength will be assessed using a isokinetic dynamometer. Back- and abdominal muscle strength will be assessed using an isokinetic dynamometer (System 3, Biodex, ENRAF-NONIUS, New York, USA). After adequate warming-up and movement familiarization, subjects will perform 3 maximal isometric contractions of back- and abdominal muscles for 4-5sec. This test will be executed in two starting positions (semi-flexed and lumbar isolated) to evaluate adequate co-contraction of m.Iliopsoas and m.Glutei during back flexion and extension respectively.
3 weeks
Muscle carnosine concentration
Time Frame: 3 weeks

Muscle biopsies will be obtained from the middle part of the m.vastus lateralis (Bergström needle technique), by an experienced medical doctor.. The first two samples will be immediately embedded in Tissue-Tek, frozen in isopentane cooled with liquid nitrogen and stored at -80°C, until further analysis will be performed. The second two samples will be 'snap freezed' between pincers cooled with liquid nitrogen, and also stored at -80°C until further analysis.

Carnosine concentrations will be determined using high-performance liquid chromatography (HPLC). Samples (15mg) are deproteinized using 35% sulfosalicylic acid and centrifuged (5min, 16,000g). Deproteinized supernatant is mixed with AccQ Fluor Borate buffer and reconstituted Fluor Reagent (1:7:2) from the AccQTag chemistry kit (Waters). Derivatized samples are applied to a Waters HPLC system comprised of an AccQTag column (3.9x150mm) and fluorescence detector (excitation/emission wavelength: 250/395nm).
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bert O Eijnde, University Hasselt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16.111/REVA16.14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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