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Clinical Trials/NCT04191772
NCT04191772
Completed
Not Applicable

The Impact of Structured Exercise on Physical Fitness, Sedentary Time, Brain Volume, Cognitive, Health-related and Immunological Parameters in Multiple Sclerosis.

Hasselt University1 site in 1 country156 target enrollmentJanuary 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Hasselt University
Enrollment
156
Locations
1
Primary Endpoint
Sitting time
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The current study aims to investigate whether persons with Multiple Sclerosis (PwMS) compensate training time with more sedentary time and consequently blunt training effects. The second aim will be to investigate the effect of a structured training program on specific brain volumes and cognitive variables.

Detailed Description

Multiple Sclerosis is a progressive, autoimmune, neurodegenerative disorder of the central nervous system (CNS) that predominantly affects young to middle-aged adults. It is characterized by a chronic inflammatory process that causes demyelination, axonal damage and white matter lesions across the CNS. Furthermore, evidence also indicates grey matter (GM) atrophy which has been reported to be significantly correlated with both clinical and cognitive deterioration. Clinical manifestations include spasticity, tremor, paralysis, walking difficulties and cognitive abnormalities. Due to these primary disease symptoms, persons with MS (PwMS) appear to be susceptible to a sedentary lifestyle and inactivity, which consequently increases the risk of other important, health-related secondary deficits including respiratory, metabolic and cardiac dysfunction. These deficits further contribute to a decrease in cardiorespiratory fitness and quality of life (QoL), thereby causing a vicious circle of decreased exercise tolerance, greater disability and increased inactivity. Since pharmacological treatment has little impact on these secondary deficits, exercise therapy has become an important aspect of the treatment of MS. Hence, exercise therapy interventions in MS have been studied extensively and have already been proven to significantly improve cardiorespiratory fitness, muscle strength, balance, fatigue, cognition, quality of life, respiratory function and brain volumes. Moreover, a dose-response relationship has been reported for functional variables such as strength and endurance capacity. As such, high intensity interval training (HIIT) probably is exerts superior effects compared to traditional low/moderate intensity continuous training (MICT). However and in contrast with other populations, effects of HIIT on important health-related variables such as body composition, blood pressure and blood lipid profiles are less evident. Possibly, PwMS do not reach the exercise intensities required to improve such factors due to cardiovascular autonomic dysfunction, leading to impaired carotid baroreflex control, attenuated elevations in blood pressure and disturbed increases in heart rate, and abnormal muscle energy metabolism. Moreover, higher intensities might hamper longer-term implementation in real life, as an inverse relation between exercise intensity and training adherence has already been reported. Training periodization (alternating HIIT and MICT) offers a solution to overcome the barrier of adherence and concurrently augmenting training effects, but in contrast to other populations, the addition of a lower intensity training component does still not improve health-related variables. Therefore, other approaches are warranted. Recently, evidence is growing that sedentary time is an important health risk factor, independent of the (dis)practice of structured exercise. Hence, PwMS possibly compensate training effects with even more sedentary time, in addition to an already sedentary lifestyle as mentioned previously. As such, addressing sedentary time might be an interesting new approach to counteract the health-related deficits in PwMS. Therefore, the present study explores the impact of a structured exercise program on sedentary time and health-related variables. Furthermore, a secondary aim of the current project is to investigate the effect of a periodized training program on brain volumes and cognitive function. Recent evidence of physical training effects on cognitive variables is contradictory. So for exercise intervention studies that studied the latter only used short-term and laboratory-based training programs and included exercise modalities (type, intensity, duration) that are difficult to compare. Interestingly, a recent short-term randomized controlled trial reported superior effects of HIIT on cognitive functions compared to MICT. Hence, the current study aims to investigate the impact of a long-term, home-based training program with HIIT-components on cognitive variables.

Registry
clinicaltrials.gov
Start Date
January 15, 2020
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Bert Op't Eijnde

Principal Investigator

Hasselt University

Eligibility Criteria

Inclusion Criteria

  • Multiple Sclerosis according to the McDonald criteria (Relaps remitting)
  • Written informed consent
  • Medical safety screening

Exclusion Criteria

  • Contra-indications to participate in moderate to high intensity exercise
  • Contra-indications to undergo magnetic resonance imaging (pacemaker/defibrillator or wires other than sternal wires, insulin pumps, metal foreign bodies, deep brain stimulator, cerebral aneurysm clips, cochlear implant, magnetic dental implant, drug infusion device)
  • Medication changes in the last month before the start of the intervention
  • Following or plan to follow a weight reduction program
  • Pregnancy
  • Participation in another study
  • Acute MS exacerbation \< 3 months prior to the start of the study
  • EDSS score \> 4
  • Consumption of more than 20 alcohol units/week
  • No daily internet access

Outcomes

Primary Outcomes

Sitting time

Time Frame: 3 months after the training program

Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Stepping time

Time Frame: 3 months after the training program

Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Number of steps per day

Time Frame: 3 months after the training program

Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Standing time

Time Frame: 3 months after the training program

Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Secondary Outcomes

  • Carbon dioxide output (VCO2)(Week 48 of the training protocol)
  • Respiratory gas exchange ratio (RER)(Week 48 of the training program)
  • Cardiorespiratory fitness (CRF)(Week 48 of the training program)
  • Lipidomic profile(Week 48 of the training program)
  • Height(Week 48 of the training program)
  • Blood pressure(Week 48 of the training program)
  • Resting heart rate(Week 48 of the training program)
  • Total calorie intake(3 months after the training program)
  • Macronutrient content(3 months after the training program)
  • Participation - Ghent Participation Scale (GPS)(Week 48 of the training program)
  • Fatigue - Modified Fatigue Impact scale (MFIS)(3 months after the training program)
  • Mobility - MS walking scale (MSWS-12)(Week 48 of the training program)
  • Oxygen uptake (VO2)(Week 48 of the training program)
  • Tidal volume (Vt)(Week 48 of the training program)
  • Breathing frequency (BF)(Week 48 of the training protocol)
  • serum cytokines(Week 48 of the training program)
  • Cognition - Spatial Recall test (SPART)(Week 48 of the training program)
  • Cognition - Symbol Digit Modalities Test (SDMT)(Week 48 of the training program)
  • Body weight(Week 48 of the training program)
  • DEXA (Dual Energy X-Ray)(Week 48 of the training program)
  • Coordination - timed tandem walk (TTW)(Week 48 of the training program)
  • Equivalents for oxygen uptake (VE/VO2)(Week 48 of the training protocol)
  • Equivalents for carbon dioxide production (VE/VCO2)(Week 48 of the training program)
  • Minute ventilation (VE)(Week 48 of the training protocol)
  • Brain volumes(Week 48 of the training program)
  • PBMC subset parameters(Week 48 of the training program)

Study Sites (1)

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