Periodized Rehabilitation and Beta-alanine Supplementation in Multiple Sclerosis

NCT03803800 | Completed

• 1 other identifier: 16.111/REVA16.14
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

Rehabilitation; Periodized exercise therapy; Ergogenic supplementation

Outcome Measures

Primary Outcomes (6)

• Exercise capacity

  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

  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

  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

  Weight (calibrated analogue weight scale) and height will be combined to report BMI in kg/m\^2.

  3 weeks

• Strength measurement

  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

  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

Study Arms (4)

Classic training & beta-alanine

EXPERIMENTAL

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

Other: Classic, progressive endurance training; Dietary Supplement: beta-alanine

Classic training & placebo

PLACEBO COMPARATOR

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

Other: Classic, progressive endurance training

Periodized training & beta-alanine

EXPERIMENTAL

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

Other: Periodized exercise training; Dietary Supplement: beta-alanine

Periodized training & placebo

PLACEBO COMPARATOR

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

Other: Periodized exercise training

Interventions

Classic, progressive endurance training 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)

Classic training & beta-alanine; Classic training & placebo

Periodized exercise training 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)

Periodized training & beta-alanine; Periodized training & placebo

beta-alanine DIETARY_SUPPLEMENT

Some subjects will receive the ergogenic supplement beta-alanine.

Classic training & beta-alanine; Periodized training & beta-alanine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Congresses as Topic; beta-Alanine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Alanine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Bert O Eijnde

  University Hasselt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 15, 2019
• Study Start: January 9, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 9, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

BE (1)