An interventional study of Periodized, home-based running program in Multiple Sclerosis, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by Hasselt University · Not applicable, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 156 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
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Exclusion Criteria:
Persons with Multiple Sclerosis (PwMS) with a 'poor VO2max', a 'fair VO2max' with no running experience and a 'good VO2max' with no running experience (VO2max values according to V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics) will receive an exercise intervention existing of home-based running sessions. Participants of the first training group will be trained to run continuously for 45 minutes.
Other: Periodized, home-based running program
Healthy control (HC) persons with a 'poor VO2max', a 'fair VO2max' with no running experience and a 'good VO2max' with no running experience (VO2max values according to V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics) will receive an exercise intervention existing of home-based running sessions. Participants of the first training group will be trained to run continuously for 45 minutes.
Other: Periodized, home-based running program
PwMS with a 'fair VO2max' and running experience, a 'good VO2max and running experience', an 'excellent VO2max' and a 'superior VO2max' (VO2max values according to V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics) will receive an exercise intervention existing of home-based running sessions. Participants of the second training group will be trained to run continuously for 75 minutes.
Other: Periodized, home-based running program
HC with a 'fair VO2max' and running experience, a 'good VO2max and running experience', an 'excellent VO2max' and a 'superior VO2max' (VO2max values according to V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics) will receive an exercise intervention existing of home-based running sessions. Participants of the second training group will be trained to run continuously for 75 minutes.
Other: Periodized, home-based running program
Twenty PwMS will receive no intervention, only usual care.
Twenty HC will receive no intervention, only usual care.
All participants will perform a home-based supervised exercise training program. Participants will receive weekly training instructions using a smartphone-based heart rate monitor application (Polar® app). Training sessions will involve running and the design of the training program will be based on linear periodization, where aerobic capacity is built firstly through a period of high-volume/low-intensity training before the proportion of high-intensity training is increased. The total duration of the exercise program will be 12 months with three weekly training sessions. Training progression will be dependent on initial VO2max values and running experience. VO2max classification is based on reference values described in V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics.
Number of steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Before start of the training program
Number of steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 1 of the training program
Number of steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 24 of the training program
Number of steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 48 of the training program
Number of steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: 3 months after the training program
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Before start of the training program
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 1 of the training program
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 24 of the training program
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 48 of the training program
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: 3 months after the training program
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Before start of the training program
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 1 of the training program
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 24 of the training program
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 48 of the training program
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: 3 months after the training program
Stepping time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Before start of the training program
Stepping time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 1 of the training program
Stepping time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 24 of the training program
Stepping time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: Week 48 of the training program
Stepping time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Time frame: 3 months after the training program
Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 4 times at 5-min intervals after an initial resting period of 10min, using an electronic sphygmomanometer (Omron®, Omron Healthcare, IL, USA) from the dominant arm and documented as the mean value of the final 3 measurements.
Time frame: Baseline
Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 4 times at 5-min intervals after an initial resting period of 10min, using an electronic sphygmomanometer (Omron®, Omron Healthcare, IL, USA) from the dominant arm and documented as the mean value of the final 3 measurements.
Time frame: Week 48 of the training program
Resting heart rate
Resting heart rate will be measured 4 times at 5-min intervals after an initial resting period of 10min, using an electronic sphygmomanometer (Omron®, Omron Healthcare, IL, USA) from the dominant arm and documented as the mean value of the final 3 measurements.
Time frame: Baseline
Resting heart rate
Resting heart rate will be measured 4 times at 5-min intervals after an initial resting period of 10min, using an electronic sphygmomanometer (Omron®, Omron Healthcare, IL, USA) from the dominant arm and documented as the mean value of the final 3 measurements.
Time frame: Week 48 of the training program
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Time frame: Baseline
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Time frame: Week 12 of the training program
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Time frame: Week 24 of the training program
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Time frame: Week 48 of the training program
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Time frame: 3 months after the training program
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Time frame: Baseline
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Time frame: Week 12 of the training program
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Time frame: Week 24 of the training program
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Time frame: Week 48 of the training program
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Time frame: 3 months after the training program
Participation - Ghent Participation Scale (GPS)
The GPS is a generic instrument including both objective and all relevant subjective variables resulting in one score, already proven to be valid to rate participation in MS.
Time frame: Baseline
Participation - Ghent Participation Scale (GPS)
The GPS is a generic instrument including both objective and all relevant subjective variables resulting in one score, already proven to be valid to rate participation in MS.
Time frame: Week 48 of the training program
Mobility - MS walking scale (MSWS-12)
The MSWS-12 is a 12-item self-assessment scale which measures the impact of MS on mobility, which showed the ability of a running program to reduce impact of MS on walking ability in a previous pilot RCT by our research group
Time frame: Baseline
Mobility - MS walking scale (MSWS-12)
The MSWS-12 is a 12-item self-assessment scale which measures the impact of MS on mobility, which showed the ability of a running program to reduce impact of MS on walking ability in a previous pilot RCT by our research group
Time frame: Week 48 of the training program
Fatigue - Modified Fatigue Impact scale (MFIS)
To evaluate the impact of structured training on fatigue, the Modified Fatigue Impact Scale (MFIS) will be used, which is the recommended questionnaire for research related to fatigue by the Multiple Sclerosis Council for Clinical guidelines. In the MFIS, the perceived impact of fatigue on physical, cognitive and psychosocial functioning of the past 4 weeks is assessed.
Time frame: Before start of the intervention
Fatigue - Modified Fatigue Impact scale (MFIS)
To evaluate the impact of structured training on fatigue, the Modified Fatigue Impact Scale (MFIS) will be used, which is the recommended questionnaire for research related to fatigue by the Multiple Sclerosis Council for Clinical guidelines. In the MFIS, the perceived impact of fatigue on physical, cognitive and psychosocial functioning of the past 4 weeks is assessed.
Time frame: Week 1 of the intervention
Fatigue - Modified Fatigue Impact scale (MFIS)
To evaluate the impact of structured training on fatigue, the Modified Fatigue Impact Scale (MFIS) will be used, which is the recommended questionnaire for research related to fatigue by the Multiple Sclerosis Council for Clinical guidelines. In the MFIS, the perceived impact of fatigue on physical, cognitive and psychosocial functioning of the past 4 weeks is assessed.
Time frame: Week 12 of the training program
Fatigue - Modified Fatigue Impact scale (MFIS)
To evaluate the impact of structured training on fatigue, the Modified Fatigue Impact Scale (MFIS) will be used, which is the recommended questionnaire for research related to fatigue by the Multiple Sclerosis Council for Clinical guidelines. In the MFIS, the perceived impact of fatigue on physical, cognitive and psychosocial functioning of the past 4 weeks is assessed.
Time frame: Week 24 of the training program
Fatigue - Modified Fatigue Impact scale (MFIS)
To evaluate the impact of structured training on fatigue, the Modified Fatigue Impact Scale (MFIS) will be used, which is the recommended questionnaire for research related to fatigue by the Multiple Sclerosis Council for Clinical guidelines. In the MFIS, the perceived impact of fatigue on physical, cognitive and psychosocial functioning of the past 4 weeks is assessed.
Time frame: Week 48 of the training program
Fatigue - Modified Fatigue Impact scale (MFIS)
To evaluate the impact of structured training on fatigue, the Modified Fatigue Impact Scale (MFIS) will be used, which is the recommended questionnaire for research related to fatigue by the Multiple Sclerosis Council for Clinical guidelines. In the MFIS, the perceived impact of fatigue on physical, cognitive and psychosocial functioning of the past 4 weeks is assessed.
Time frame: 3 months after the training program
Cognition - Spatial Recall test (SPART)
The SPART is a visuospatial learning and delayed recall test, where a checkerboard with seven checkers in specified places is presented for 10sec to the participants who have to place the checkers back on a blank checkerboard immediately after and after another 30min. The total score is a sum of the correct checkers. This has been shown to be one of the most sensitive measures for detecting memory impairments in PwMS and showed improved performance after a running program in a previous pilot RCT of our research group
Time frame: Baseline
Cognition - Spatial Recall test (SPART)
The SPART is a visuospatial learning and delayed recall test, where a checkerboard with seven checkers in specified places is presented for 10sec to the participants who have to place the checkers back on a blank checkerboard immediately after and after another 30min. The total score is a sum of the correct checkers. This has been shown to be one of the most sensitive measures for detecting memory impairments in PwMS and showed improved performance after a running program in a previous pilot RCT of our research group
Time frame: Week 48 of the training program
Cognition - Symbol Digit Modalities Test (SDMT)
The SDMT is a test of information processing speed (PS) in which participants need to combine as many symbols with the accompanying numbers as possible in 90 seconds. The SDMT has been found to be a reliable and valid test in MS and a responder definition of approximating 4 points or 10% in magnitude SDMT change was recommended.
Time frame: Baseline
Cognition - Symbol Digit Modalities Test (SDMT)
The SDMT is a test of information processing speed (PS) in which participants need to combine as many symbols with the accompanying numbers as possible in 90 seconds. The SDMT has been found to be a reliable and valid test in MS and a responder definition of approximating 4 points or 10% in magnitude SDMT change was recommended.
Time frame: Week 48 of the training program
Body weight
Body weight is determined using a digital-balanced weighting scale to the nearest 0.1kg
Time frame: Baseline
Body weight
Body weight is determined using a digital-balanced weighting scale to the nearest 0.1kg
Time frame: Week 48 of the training program
Height
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
Time frame: Baseline
Height
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
Time frame: Week 48 of the training program
DEXA (Dual Energy X-Ray)
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
Time frame: Baseline
DEXA (Dual Energy X-Ray)
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
Time frame: Week 48 of the training program
Coordination - timed tandem walk (TTW)
Participants will have to walk in a straight line with one foot immediately in front of the other (heel to toe), while the arms are kept down at the side. Time to complete 3 meter will be monitored.
Time frame: Baseline
Coordination - timed tandem walk (TTW)
Participants will have to walk in a straight line with one foot immediately in front of the other (heel to toe), while the arms are kept down at the side. Time to complete 3 meter will be monitored.
Time frame: Week 48 of the training program
Oxygen uptake (VO2)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: Baseline
Oxygen uptake (VO2)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: Week 48 of the training program
Carbon dioxide output (VCO2)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VCO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: Baseline
Carbon dioxide output (VCO2)
Cardiopulmonary exercise test on on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VCO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: Week 48 of the training protocol
Minute ventilation (VE)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE is collected breath-by-breath and averaged every ten seconds.
Time frame: Baseline
Minute ventilation (VE)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE is collected breath-by-breath and averaged every ten seconds.
Time frame: Week 48 of the training protocol
Equivalents for oxygen uptake (VE/VO2)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: Baseline
Equivalents for oxygen uptake (VE/VO2)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: Week 48 of the training protocol
Equivalents for carbon dioxide production (VE/VCO2)
Cardiopulmonary exercise test on on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VCO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: Baseline
Equivalents for carbon dioxide production (VE/VCO2)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VCO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: Week 48 of the training program
Tidal volume (Vt)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis Vt is collected breath-by-breath and averaged every ten seconds.
Time frame: Baseline
Tidal volume (Vt)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis Vt is collected breath-by-breath and averaged every ten seconds.
Time frame: Week 48 of the training program
Breathing frequency (BF)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis BF is collected breath-by-breath and averaged every ten seconds.
Time frame: Baseline
Breathing frequency (BF)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis BF is collected breath-by-breath and averaged every ten seconds.
Time frame: Week 48 of the training protocol
Respiratory gas exchange ratio (RER)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis RER is collected breath-by-breath and averaged every ten seconds.
Time frame: Baseline
Respiratory gas exchange ratio (RER)
Cardiopulmonary exercise test on a bicycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis RER is collected breath-by-breath and averaged every ten seconds.
Time frame: Week 48 of the training program
Cardiorespiratory fitness (CRF)
CRF will be measured with a maximal cardiopulmonary exercise test on a bicycle ergometer.
Time frame: Baseline
Cardiorespiratory fitness (CRF)
CRF will be measured with a maximal cardiopulmonary exercise test on a bicycle ergometer.
Time frame: Week 48 of the training program
Lipidomic profile
Blood analysis
Time frame: Baseline
Lipidomic profile
Blood analysis
Time frame: Week 48 of the training program
Brain volumes
MRI scan
Time frame: Baseline
Brain volumes
MRI scan
Time frame: Week 48 of the training program
PBMC subset parameters
flow cytometry analysis of immune cell subsets in peripheral blood-derived mononuclear cells (PBMCs)
Time frame: Baseline
PBMC subset parameters
flow cytometry analysis of immune cell subsets in peripheral blood-derived mononuclear cells (PBMCs)
Time frame: Week 48 of the training program
serum cytokines
cytokine levels are measured by ELISA on serum derived from peripheral blood samples
Time frame: Baseline
serum cytokines
cytokine levels are measured by ELISA on serum derived from peripheral blood samples
Time frame: Week 48 of the training program
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Hasselt University