Ignite Creation Date:
2024-05-06 @ 7:39 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02571335
Status:
COMPLETED
Last Update Posted:
2016-08-30
First Post:
2015-09-23
Brief Title:
Impacts of Different Training Modes Intense Versus Ordinary on the Immune System and Memory Functions in pwMS
Sponsor:
Klinik Valens
Organization:
Klinik Valens
Study Overview
Official Title:
Intensity-dependent Impacts of Training on Growth Factors BDNF and Cognitive Functions in Persons With Multiple Sclerosis - a Single-center Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple Sclerosis MS is a chronic immune-mediated disease of the central nervous system accompanied by varying inflammatory manifestations demyelinization and axonal loss With chronic progressive or relapsing-remitting disease onsets persons with MS pwMS progressively develop impaired functional capacity and show reduced physical activity and cognitive decline compared to healthy controls The primary aims of rehabilitation in pwMS are therefore to increase levels of activity and participation leading to increase independence of the participants In general exercise ranges from passive physiotherapy-based interventions to submaximal endurance training sessions Current recommendations advise pwMS that exercise should be matched with the individual performance capacities Exercise training in pwMS then has the potential to target and improve many components outlined in the ICF-model
Cytokines and neurotrophic factors have received increased attention in MS research and addressed the brain-derived neurotrophic factor BDNF as an important mediator of neuronal regeneration linking the effects of exercise with MS pathogenesis Data show positive connections between elevated neurotrophin concentrations induction of neuroplasticity recovery of the motor and cognitive functions and the applied training intensities Similarly intensive and progressive exercise bouts seem to have greater benefits on cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with dementia Therefore specific exercise prescriptions may be necessary for targeting the specific impairments also in pwMS
This study aims to evaluate two different training modalities intensive versus normal in pwMS It is expected that both modalities will improve cardiorespiratory fitness and cognitive functions in pwMS Based on the findings that higher training intensities facilitate greater benefits it is expected that pwMS will tolerate the intensive training intensities and show positive connections to elevated neurotrophin concentrations
The results will to help to clearer understand the benefits of each type of exercise conveyed for pwMS and will assist in the development of patient-specific exercise prescriptions
Cytokines and neurotrophic factors have received increased attention in MS research and addressed the brain-derived neurotrophic factor BDNF as an important mediator of neuronal regeneration linking the effects of exercise with MS pathogenesis Data show positive connections between elevated neurotrophin concentrations induction of neuroplasticity recovery of the motor and cognitive functions and the applied training intensities Similarly intensive and progressive exercise bouts seem to have greater benefits on cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with dementia Therefore specific exercise prescriptions may be necessary for targeting the specific impairments also in pwMS
This study aims to evaluate two different training modalities intensive versus normal in pwMS It is expected that both modalities will improve cardiorespiratory fitness and cognitive functions in pwMS Based on the findings that higher training intensities facilitate greater benefits it is expected that pwMS will tolerate the intensive training intensities and show positive connections to elevated neurotrophin concentrations
The results will to help to clearer understand the benefits of each type of exercise conveyed for pwMS and will assist in the development of patient-specific exercise prescriptions
Detailed Description:
This study aims to evaluate two different training modalities intensive versus normal in pwMS It is expected that both modalities will improve cardiorespiratory fitness and cognitive functions in pwMS Based on the findings that higher training intensities facilitate greater benefits it is expected that pwMS will tolerate the intensive training intensities and show positive connections to elevated neurotrophin concentrations
Primary outcomes are the acute after CPET and chronic 3-week training intervention changes of neurotrophic factors and cognitive functions All other measures are secondary outcomes Training values VO2peak Workload Heart rate Fatigue FSMC Anxiety and Depression HADS
Participants are eligible if they hold a definite diagnosis of multiple sclerosis revised McDonald criteria an EDSS score of 10 -60 they give no written consent severe cardiovascular exacerbations RR 240120 HR above the age predicted maximum of 220-Age are persistent they hold severe cognitive impairments they face severe disease progression or relapses
Main measurements and procedures include
Blood sampling Blood samples 10ml of the primary outcomes will be taken by vein puncture from the antecubital vein in a seated position before the exercise bout and straight after reaching VO2peak during cool down with the participant still seated on the ergometer
Before samples are taken the participant will be required to relax for 10 minutes blood sampling will take approximately 5 minutes
Cardiopulmonary Exercise Test CPET Cardiorespiratory fitness is assessed through a progressive CPET performed at baseline on a cycle ergometer at t1 and is repeated the day prior to discharge at t2
The exercise protocol consists of a first 3 minutes at rest no pedalling on the cycle ergometer b 3 minutes of unloaded pedalling as a warm up c testing phase until the participant reaches a symptom limited maximum Workload is continuously ramp type increased by 5-10 Watts every minute to ensure 8-12 minutes of testing d the final 3 minutes are unloaded pedalling to cool down Heart rate Polar Electro Kempele Finland and blood pressure Riva-Rocci are monitored for the last 10 seconds every 2 minutes during the test The 10-point BORG scale therapy short-form assesses the rate of perceived exertion RPE at phases c and d Blood samples are drawn at rest prior to phase a and at the end of CPET phase d at t1 and t2
Cognitive assessments Cognitive assessments will be performed using the German version of the Brief International Cognitive Assessment for Multiple Sclerosis BICAMS Additionally the German version of the Trail-Making-Pencil-Test versions AB TMT-AB and GonoGo TAP version will be used Cognitive assessments will be performed at baseline t1 and repeated at t2
Fatigue Fatigue is assessed with the multidimensional FSMC scale before CPET under resting conditions FSMC has defined cut-off scores to classify mildly moderately and severely fatigued patients Cut-off for fatigue is set for the total score at 43 and for the motoric and cognitive sub-scores at 22 The scale has a proven test-retest liability and has been translated into multiple languages
Depression and Anxiety Depression and anxiety are assessed with the Hospital Anxiety and Depression Scale HADS The HADS is a self-assessment questionnaire for adults with physical ailments that assess anxiety and depression The questionnaire consists of 14 items seven for anxiety seven for depression with higher scores indicating anxiety or depression
Training Endurance training in both groups consisted of physiologically defined heart rate controlled cycling at 50-60 rounds per minutes rpm and progressive resistance training All participants will be stratified according to their cardiorespiratory fitness and level of cognitive fatigue in to group Intensive Training IT and Normal Training NT Training groups differ in the applied intensities and frequencies
The IT will train less frequent but training sessions will be more intensive in its effects Training will be performed daily in six sessions three morning and three afternoon sessions synchronized and individually matched to a ratio of active versus passive sessions of 21
The NT is the normal training performed out of the daily routine and outlines the usual care of the Valens clinic Training will be performed in maximal eight training sessions and will not be synchronized and not individually matched to a ratio of active versus passive sessions
Primary outcomes are the acute after CPET and chronic 3-week training intervention changes of neurotrophic factors and cognitive functions All other measures are secondary outcomes Training values VO2peak Workload Heart rate Fatigue FSMC Anxiety and Depression HADS
Participants are eligible if they hold a definite diagnosis of multiple sclerosis revised McDonald criteria an EDSS score of 10 -60 they give no written consent severe cardiovascular exacerbations RR 240120 HR above the age predicted maximum of 220-Age are persistent they hold severe cognitive impairments they face severe disease progression or relapses
Main measurements and procedures include
Blood sampling Blood samples 10ml of the primary outcomes will be taken by vein puncture from the antecubital vein in a seated position before the exercise bout and straight after reaching VO2peak during cool down with the participant still seated on the ergometer
Before samples are taken the participant will be required to relax for 10 minutes blood sampling will take approximately 5 minutes
Cardiopulmonary Exercise Test CPET Cardiorespiratory fitness is assessed through a progressive CPET performed at baseline on a cycle ergometer at t1 and is repeated the day prior to discharge at t2
The exercise protocol consists of a first 3 minutes at rest no pedalling on the cycle ergometer b 3 minutes of unloaded pedalling as a warm up c testing phase until the participant reaches a symptom limited maximum Workload is continuously ramp type increased by 5-10 Watts every minute to ensure 8-12 minutes of testing d the final 3 minutes are unloaded pedalling to cool down Heart rate Polar Electro Kempele Finland and blood pressure Riva-Rocci are monitored for the last 10 seconds every 2 minutes during the test The 10-point BORG scale therapy short-form assesses the rate of perceived exertion RPE at phases c and d Blood samples are drawn at rest prior to phase a and at the end of CPET phase d at t1 and t2
Cognitive assessments Cognitive assessments will be performed using the German version of the Brief International Cognitive Assessment for Multiple Sclerosis BICAMS Additionally the German version of the Trail-Making-Pencil-Test versions AB TMT-AB and GonoGo TAP version will be used Cognitive assessments will be performed at baseline t1 and repeated at t2
Fatigue Fatigue is assessed with the multidimensional FSMC scale before CPET under resting conditions FSMC has defined cut-off scores to classify mildly moderately and severely fatigued patients Cut-off for fatigue is set for the total score at 43 and for the motoric and cognitive sub-scores at 22 The scale has a proven test-retest liability and has been translated into multiple languages
Depression and Anxiety Depression and anxiety are assessed with the Hospital Anxiety and Depression Scale HADS The HADS is a self-assessment questionnaire for adults with physical ailments that assess anxiety and depression The questionnaire consists of 14 items seven for anxiety seven for depression with higher scores indicating anxiety or depression
Training Endurance training in both groups consisted of physiologically defined heart rate controlled cycling at 50-60 rounds per minutes rpm and progressive resistance training All participants will be stratified according to their cardiorespiratory fitness and level of cognitive fatigue in to group Intensive Training IT and Normal Training NT Training groups differ in the applied intensities and frequencies
The IT will train less frequent but training sessions will be more intensive in its effects Training will be performed daily in six sessions three morning and three afternoon sessions synchronized and individually matched to a ratio of active versus passive sessions of 21
The NT is the normal training performed out of the daily routine and outlines the usual care of the Valens clinic Training will be performed in maximal eight training sessions and will not be synchronized and not individually matched to a ratio of active versus passive sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None