Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02408367
Status:
UNKNOWN
Last Update Posted:
2015-04-21
First Post:
2015-03-31
Brief Title:
Intensity Depended Impacts on Cognitive Functions in Persons With Multiple Sclerosis - a Pilot Study
Sponsor:
Jens Bansi
Organization:
Klinik Valens
Study Overview
Official Title:
Intensity Depended Impact of a Single Exercise Bout on Cognitive Functions in Persons With Multiple Sclerosis - a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2015-04
Last Known Status:
RECRUITING
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 autoimmune disease where lymphocytes inflict damage to the axons and myelin sheaths of the central nervous system Persons with multiple sclerosis pwMS were long advised to avoid physical activity but the benefits of exercise to improve cardiovascular and cognitive functions in pwMS have become important aspects of standardized rehabilitation programs Recent findings show that the achieved adaptations through exercise are associated with the intensity dependent lactate increases during exercise This dose-response relationship between the mode and the exercise intensity implicates the relevance of the exercise protocol as higher exercise intensities seem to facilitate greater benefits also in pwMS
This pilot study evaluates the influences of acute bout of moderate physical exercise cycling and relaxation on cognitive functions at three time points
Primary outcomes are the differences at timepoint t2 of cognitive functions assessed via the Symbol Digit Modalities Test SDMT and the Brief Visuospatial Memory Test Revised BVMT-R T1-3 of the BICAMS battery
Results should into a randomised controlled Trial that investigates the specific influences of a three-week training intervention on Brain-derived neurotrophic factors BDNF Insulin Growth Factor-1 IGF-1 and Vascular Endothelial Growth Factor VEGF as central neurobiological parameters of neuroplasticity cardiorespiratory Fitness and cognitive functions
This pilot study evaluates the influences of acute bout of moderate physical exercise cycling and relaxation on cognitive functions at three time points
Primary outcomes are the differences at timepoint t2 of cognitive functions assessed via the Symbol Digit Modalities Test SDMT and the Brief Visuospatial Memory Test Revised BVMT-R T1-3 of the BICAMS battery
Results should into a randomised controlled Trial that investigates the specific influences of a three-week training intervention on Brain-derived neurotrophic factors BDNF Insulin Growth Factor-1 IGF-1 and Vascular Endothelial Growth Factor VEGF as central neurobiological parameters of neuroplasticity cardiorespiratory Fitness and cognitive functions
Detailed Description:
Objectives To determine responses of an acute moderate exercise bout on cognitive functions in pwMS
Hypothesis
Comparisons of different Training modes exercise overland cycling versus relaxation
Improvements of cognitive functionning Memory processing Speed on the Symbol Digit Modalities Test SDMT and the Brief Visuospatial Memory Test Revised BVMT-R T1-3
Correlations between the intensity-dependent lactate increases and cognitive functions
Experimental design Two-pronged case controlled study Randomization of 20 MS patients into a Group Exercise n10 - that perform 30 minutes cycling on an Ergometer - or Relaxation n10 that perform relaxation in a comfortable and quiet environment Both groups crossover at t2 into the respective Group The study is set into the normal rehabilitation program and participants are given physician clearance are informed about the study and give their written consent before the study starts
Cognitive assessment is performed with the Symbol Digit Modalities Test SDMT and the Brief Visuospatial Memory Test Revised BVMT-R T1-3
SDMT tests information of processing speed The test consists of single digits paired with abstract symbols Rows of the nine symbols are arranged pseudo-randomly The participant must say the number that corresponds with each symbol The SDMT can be completed within 5 min including instructions practice and testing The good psychometric properties of the SDMT are well described
BVMT-R T1-3 requires the the participant to inspect a 2 3 stimulus array of abstract geometric figures There are three learning trials of 10 s The array is removed and the patient is required to draw the array from memory with the correct shapes in the correct position The psychometric properties of the BVMT-R T1-3 are good Cognitive functions are assessed at time points t1 and t2 after Exercise Relaxation
At baseline participants perform a progressive cardiopulmonary exercise test CPET on a cycle ergometer Ergoline 800 Germany Cardiopulmonary fitness level was monitored by direct and continuous measurements breath by breath of maximum oxygen consumption VO2peak by ergospirometer PanGas CPX Germany
The exercise protocol consisted 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 reached a symptom limited maximum Workload was continuously ramp type increased by 5-10 Watts every minute to ensure 8-12 minutes of testing d the final 3 minutes were unloaded pedalling to cool down Heart rate Polar Electro Kempele Finland and blood pressure Riva Rocci were monitored for the last 10 seconds every 2 minutes during the test The 10-point BORG scale therapy short form assessed the rate of perceived exertion RPE at phases c and d Peak oxygen consumption VO2peak was defined as the highest VO2 value when the following criteria were attained respiratory equivalent ratio RER 110 peak heart rate HRpeak within 10 min-1 of age predicted maximum and rating of exertion RPE 85
The exercise bout consists of 30 minutes physiologically defined heart rate controlled cycling at 50-60 rounds per minutes rpm at the lactate threshold equal to 75 of HRpeak or 60 VO2max
Relaxation consists of 30 minutes resting in a comfortable and quiet surrounding Exercise and Relaxation are performed at timepoints t1 and t2
Hypothesis
Comparisons of different Training modes exercise overland cycling versus relaxation
Improvements of cognitive functionning Memory processing Speed on the Symbol Digit Modalities Test SDMT and the Brief Visuospatial Memory Test Revised BVMT-R T1-3
Correlations between the intensity-dependent lactate increases and cognitive functions
Experimental design Two-pronged case controlled study Randomization of 20 MS patients into a Group Exercise n10 - that perform 30 minutes cycling on an Ergometer - or Relaxation n10 that perform relaxation in a comfortable and quiet environment Both groups crossover at t2 into the respective Group The study is set into the normal rehabilitation program and participants are given physician clearance are informed about the study and give their written consent before the study starts
Cognitive assessment is performed with the Symbol Digit Modalities Test SDMT and the Brief Visuospatial Memory Test Revised BVMT-R T1-3
SDMT tests information of processing speed The test consists of single digits paired with abstract symbols Rows of the nine symbols are arranged pseudo-randomly The participant must say the number that corresponds with each symbol The SDMT can be completed within 5 min including instructions practice and testing The good psychometric properties of the SDMT are well described
BVMT-R T1-3 requires the the participant to inspect a 2 3 stimulus array of abstract geometric figures There are three learning trials of 10 s The array is removed and the patient is required to draw the array from memory with the correct shapes in the correct position The psychometric properties of the BVMT-R T1-3 are good Cognitive functions are assessed at time points t1 and t2 after Exercise Relaxation
At baseline participants perform a progressive cardiopulmonary exercise test CPET on a cycle ergometer Ergoline 800 Germany Cardiopulmonary fitness level was monitored by direct and continuous measurements breath by breath of maximum oxygen consumption VO2peak by ergospirometer PanGas CPX Germany
The exercise protocol consisted 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 reached a symptom limited maximum Workload was continuously ramp type increased by 5-10 Watts every minute to ensure 8-12 minutes of testing d the final 3 minutes were unloaded pedalling to cool down Heart rate Polar Electro Kempele Finland and blood pressure Riva Rocci were monitored for the last 10 seconds every 2 minutes during the test The 10-point BORG scale therapy short form assessed the rate of perceived exertion RPE at phases c and d Peak oxygen consumption VO2peak was defined as the highest VO2 value when the following criteria were attained respiratory equivalent ratio RER 110 peak heart rate HRpeak within 10 min-1 of age predicted maximum and rating of exertion RPE 85
The exercise bout consists of 30 minutes physiologically defined heart rate controlled cycling at 50-60 rounds per minutes rpm at the lactate threshold equal to 75 of HRpeak or 60 VO2max
Relaxation consists of 30 minutes resting in a comfortable and quiet surrounding Exercise and Relaxation are performed at timepoints t1 and t2
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