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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803800
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Bert Op't Eijnde, Hasselt University

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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Classic, progressive endurance training Other: Periodized exercise training Dietary Supplement: beta-alanine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

All subjects involved (participants, care providor, asessor) are blinded to the supplementation (beta-alanine vs placebo).

Outcome assessors are blinded to the exercise intervention (classic vs periodized training)

Primary Purpose: Other
Official Title: Periodized Rehabilitation and Beta-alanine Supplementation in Multiple Sclerosis
Actual Study Start Date : January 9, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 9, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Alanine

Arm Intervention/treatment
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).
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)

Dietary Supplement: beta-alanine
Some subjects will receive the ergogenic supplement beta-alanine.

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)




Primary Outcome Measures :
  1. 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).

  2. 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. 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).

  4. Body mass index [ Time Frame: 3 weeks ]
    Weight (calibrated analogue weight scale) and height will be combined to report BMI in kg/m^2.

  5. 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.

  6. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803800


Locations
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Belgium
Hasselt University
Diepenbeek, Limburg, Belgium, 3590
Sponsors and Collaborators
Hasselt University
Investigators
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Principal Investigator: Bert O Eijnde University Hasselt
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Responsible Party: Bert Op't Eijnde, Prof. Dr., Hasselt University
ClinicalTrials.gov Identifier: NCT03803800    
Other Study ID Numbers: 16.111/REVA16.14
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bert Op't Eijnde, Hasselt University:
Rehabilitation
Periodized exercise therapy
Ergogenic supplementation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases