- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04191772
The Impact of Training on Sitting Time and Brain Volumes in Multiple Sclerosis. (EXIMS)
The Impact of Structured Exercise on Physical Fitness, Sedentary Time, Brain Volume, Cognitive, Health-related and Immunological Parameters in Multiple Sclerosis.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Diepenbeek, Limburg, Belgium, 3590
- Hasselt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MS - training goal 1
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.
|
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.
|
EXPERIMENTAL: HC - training goal 1
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.
|
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.
|
EXPERIMENTAL: MS - training goal 2
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.
|
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.
|
EXPERIMENTAL: HC - training goal 2
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.
|
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.
|
NO_INTERVENTION: MS - sedentary control group
Twenty PwMS will receive no intervention, only usual care.
|
|
NO_INTERVENTION: HC - sedentary control group
Twenty HC will receive no intervention, only usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of steps per day
Time Frame: Before start of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Before start of the training program
|
Number of steps per day
Time Frame: Week 1 of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 1 of the training program
|
Number of steps per day
Time Frame: Week 24 of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 24 of the training program
|
Number of steps per day
Time Frame: Week 48 of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 48 of the training program
|
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).
|
3 months after the training program
|
Sitting time
Time Frame: Before start of the training program
|
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Before start of the training program
|
Sitting time
Time Frame: Week 1 of the training program
|
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 1 of the training program
|
Sitting time
Time Frame: Week 24 of the training program
|
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 24 of the training program
|
Sitting time
Time Frame: Week 48 of the training program
|
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 48 of the training program
|
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).
|
3 months after the training program
|
Standing time
Time Frame: Before start of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Before start of the training program
|
Standing time
Time Frame: Week 1 of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 1 of the training program
|
Standing time
Time Frame: Week 24 of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 24 of the training program
|
Standing time
Time Frame: Week 48 of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 48 of the training program
|
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).
|
3 months after the training program
|
Stepping time
Time Frame: Before start of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Before start of the training program
|
Stepping time
Time Frame: Week 1 of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 1 of the training program
|
Stepping time
Time Frame: Week 24 of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 24 of the training program
|
Stepping time
Time Frame: Week 48 of the training program
|
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
|
Week 48 of the training program
|
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).
|
3 months after the training program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Baseline
|
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.
|
Baseline
|
Blood pressure
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Resting heart rate
Time Frame: Baseline
|
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.
|
Baseline
|
Resting heart rate
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Total calorie intake
Time Frame: Baseline
|
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
|
Baseline
|
Total calorie intake
Time Frame: Week 12 of the training program
|
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
|
Week 12 of the training program
|
Total calorie intake
Time Frame: Week 24 of the training program
|
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
|
Week 24 of the training program
|
Total calorie intake
Time Frame: Week 48 of the training program
|
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
|
Week 48 of the training program
|
Total calorie intake
Time Frame: 3 months after the training program
|
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
|
3 months after the training program
|
Macronutrient content
Time Frame: Baseline
|
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
|
Baseline
|
Macronutrient content
Time Frame: Week 12 of the training program
|
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
|
Week 12 of the training program
|
Macronutrient content
Time Frame: Week 24 of the training program
|
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
|
Week 24 of the training program
|
Macronutrient content
Time Frame: Week 48 of the training program
|
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
|
Week 48 of the training program
|
Macronutrient content
Time Frame: 3 months after the training program
|
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
|
3 months after the training program
|
Participation - Ghent Participation Scale (GPS)
Time Frame: Baseline
|
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.
|
Baseline
|
Participation - Ghent Participation Scale (GPS)
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Mobility - MS walking scale (MSWS-12)
Time Frame: Baseline
|
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
|
Baseline
|
Mobility - MS walking scale (MSWS-12)
Time Frame: Week 48 of the training program
|
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
|
Week 48 of the training program
|
Fatigue - Modified Fatigue Impact scale (MFIS)
Time Frame: Before start of the intervention
|
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.
|
Before start of the intervention
|
Fatigue - Modified Fatigue Impact scale (MFIS)
Time Frame: Week 1 of the intervention
|
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.
|
Week 1 of the intervention
|
Fatigue - Modified Fatigue Impact scale (MFIS)
Time Frame: Week 12 of the training program
|
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.
|
Week 12 of the training program
|
Fatigue - Modified Fatigue Impact scale (MFIS)
Time Frame: Week 24 of the training program
|
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.
|
Week 24 of the training program
|
Fatigue - Modified Fatigue Impact scale (MFIS)
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Fatigue - Modified Fatigue Impact scale (MFIS)
Time Frame: 3 months after the training program
|
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.
|
3 months after the training program
|
Cognition - Spatial Recall test (SPART)
Time Frame: Baseline
|
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
|
Baseline
|
Cognition - Spatial Recall test (SPART)
Time Frame: Week 48 of the training program
|
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
|
Week 48 of the training program
|
Cognition - Symbol Digit Modalities Test (SDMT)
Time Frame: Baseline
|
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.
|
Baseline
|
Cognition - Symbol Digit Modalities Test (SDMT)
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Body weight
Time Frame: Baseline
|
Body weight is determined using a digital-balanced weighting scale to the nearest 0.1kg
|
Baseline
|
Body weight
Time Frame: Week 48 of the training program
|
Body weight is determined using a digital-balanced weighting scale to the nearest 0.1kg
|
Week 48 of the training program
|
Height
Time Frame: Baseline
|
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
|
Baseline
|
Height
Time Frame: Week 48 of the training program
|
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
|
Week 48 of the training program
|
DEXA (Dual Energy X-Ray)
Time Frame: Baseline
|
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
|
Baseline
|
DEXA (Dual Energy X-Ray)
Time Frame: Week 48 of the training program
|
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
|
Week 48 of the training program
|
Coordination - timed tandem walk (TTW)
Time Frame: Baseline
|
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.
|
Baseline
|
Coordination - timed tandem walk (TTW)
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Oxygen uptake (VO2)
Time Frame: Baseline
|
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.
|
Baseline
|
Oxygen uptake (VO2)
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Carbon dioxide output (VCO2)
Time Frame: Baseline
|
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.
|
Baseline
|
Carbon dioxide output (VCO2)
Time Frame: Week 48 of the training protocol
|
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.
|
Week 48 of the training protocol
|
Minute ventilation (VE)
Time Frame: Baseline
|
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.
|
Baseline
|
Minute ventilation (VE)
Time Frame: Week 48 of the training protocol
|
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.
|
Week 48 of the training protocol
|
Equivalents for oxygen uptake (VE/VO2)
Time Frame: Baseline
|
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.
|
Baseline
|
Equivalents for oxygen uptake (VE/VO2)
Time Frame: Week 48 of the training protocol
|
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.
|
Week 48 of the training protocol
|
Equivalents for carbon dioxide production (VE/VCO2)
Time Frame: Baseline
|
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.
|
Baseline
|
Equivalents for carbon dioxide production (VE/VCO2)
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Tidal volume (Vt)
Time Frame: Baseline
|
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.
|
Baseline
|
Tidal volume (Vt)
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Breathing frequency (BF)
Time Frame: Baseline
|
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.
|
Baseline
|
Breathing frequency (BF)
Time Frame: Week 48 of the training protocol
|
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.
|
Week 48 of the training protocol
|
Respiratory gas exchange ratio (RER)
Time Frame: Baseline
|
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.
|
Baseline
|
Respiratory gas exchange ratio (RER)
Time Frame: Week 48 of the training program
|
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.
|
Week 48 of the training program
|
Cardiorespiratory fitness (CRF)
Time Frame: Baseline
|
CRF will be measured with a maximal cardiopulmonary exercise test on a bicycle ergometer.
|
Baseline
|
Cardiorespiratory fitness (CRF)
Time Frame: Week 48 of the training program
|
CRF will be measured with a maximal cardiopulmonary exercise test on a bicycle ergometer.
|
Week 48 of the training program
|
Lipidomic profile
Time Frame: Baseline
|
Blood analysis
|
Baseline
|
Lipidomic profile
Time Frame: Week 48 of the training program
|
Blood analysis
|
Week 48 of the training program
|
Brain volumes
Time Frame: Baseline
|
MRI scan
|
Baseline
|
Brain volumes
Time Frame: Week 48 of the training program
|
MRI scan
|
Week 48 of the training program
|
PBMC subset parameters
Time Frame: Baseline
|
flow cytometry analysis of immune cell subsets in peripheral blood-derived mononuclear cells (PBMCs)
|
Baseline
|
PBMC subset parameters
Time Frame: Week 48 of the training program
|
flow cytometry analysis of immune cell subsets in peripheral blood-derived mononuclear cells (PBMCs)
|
Week 48 of the training program
|
serum cytokines
Time Frame: Baseline
|
cytokine levels are measured by ELISA on serum derived from peripheral blood samples
|
Baseline
|
serum cytokines
Time Frame: Week 48 of the training program
|
cytokine levels are measured by ELISA on serum derived from peripheral blood samples
|
Week 48 of the training program
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXIMS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Brigham and Women's HospitalMassachusetts General HospitalRecruitingMultiple Sclerosis | Relapsing Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
University of MinnesotaMallinckrodtTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
Clinical Trials on Periodized, home-based running program
-
NYU Langone HealthCompletedStroke | Cerebral Vascular Accident (CVA)United States
-
Lille Catholic UniversityCompletedRehabilitation | Elderly | FallsFrance
-
Hospital Authority, Hong KongThe Hong Kong Polytechnic UniversityUnknownHip Fractures | RehabilitationHong Kong
-
Mayo ClinicWithdrawn
-
Fondazione Salvatore MaugeriCompleted
-
Chang Gung Memorial HospitalRecruiting
-
University of Maryland, BaltimoreUniversity of SouthamptonActive, not recruitingStrokeUnited States
-
National Taiwan University HospitalNational Health Research Institutes, Taiwan; National Taiwan UniversityCompleted
-
VA Office of Research and DevelopmentNot yet recruiting
-
Nicole HildebrandUniversity Medical Center Groningen; University of Turin, ItalyRecruitingCancer | Weight, Body | Cancer of Pancreas | Aerobic Capacity | Preoperative Physical Exercise Training | Aerobic Fitness | Functional MobilityNetherlands, Italy