Multiple Sclerosis, Relapsing-RemittingNCT04121637
To Investigate the Effect of Aerobic Exercise on Neurophysiological Values and Functionality in Individuals With Multiple Sclerosis.
A study testing Aerobic Exercise and Frenkel coordination exercises in people with Multiple Sclerosis, Relapsing-Remitting and FNDC5, run by Firat University.
Trial summary
Multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system, is characterized by myelin, oligodendrocytes and axon damage. Physical exercises can be beneficial to patients, reduce fatigue and improve their strength, endurance and quality of life. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, FNDC5, Irisin Hormone
- What is being tested?
- Aerobic Exercise and Frenkel coordination exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EDSS score in the range of 0.5-5.5,
- Patients with relapsing-remitting type MS
- Patients diagnosed with MS who did not receive steroid therapy or were discontinued 3 months before starting the study.
Who cannot join
- Has an acute MS attack or has a history of attacks in the last 3 months,
- Have orthopedic or systemic problems to prevent participation in the exercises,
- Another known neuromuscular disorder other than MS,
- Immunomodulatory therapy started in the last 6 months,
- Have visual involvement or diplopia,
- Upper spasticity of lower limbs (Ashworth score 3 or 4),
- Patients with cardio-pulmonary problems that would prevent their participation in the exercise.
Trial locations and contacts
No sites are listed yet.
About this study
Multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system, is characterized by myelin, oligodendrocytes and axon damage.
Physical exercises can be beneficial to patients, reduce fatigue and improve their strength, endurance and quality of life. Exercise has the potential to improve and / or preserve functionality, aerobic condition, strength, fatigue, health-related quality of life, depression, and cognition in MS patients. It has been reported that aerobic exercise increases muscle strength and endurance in peak oxygen intake and decreases fatigue and improves activity level, balance and walking patterns.
Read more
It is important to control the problems caused by ataxia in MS patients, to improve balance and postural reactions and to increase proximal muscle and trunk stabilization. For this purpose, movements are voluntarily and graded. Progress in exercises is achieved by making changes in the speed, width and complexity of movement. However, Frenkel Coordination exercises for extremity ataxia are usually included in the physiotherapy and rehabilitation program.
Little is known about the role and function of the iris in the nervous system with the discovery of Irisin and its precursor protein FNDC5. Evidence that the plasma level of iris increases during physical exercise suggests that it may also have beneficial and neuroprotective effects in the brain. Increased physical exercise has been shown to be associated with FNDC5 expression and ultimately more secretion of the iris.
The effect of elevated plasma iris levels after aerobic exercise on functionality in MS patients is unknown. Moon et al. Observed that cellular proliferation in mouse hippocampus cells was dose-dependent due to iris. In spraque dawley-type male rats, the presence of significant iris in the myelin sheath of the skeletal muscle shows that this tissue is an important source of iris. Based on these findings, it is thought that exercise-induced iris, which is an important cause of disability in MS, may have beneficial effects on the recovery of normal function in these patients. Whether iris affects nerve conduction velocity will be determined by electromyography analysis before and after aerobic exercise. In addition, the relationship between aerobic exercise and motor and sensory function and iris will be investigated and evaluated with functional tests.
Read the detailed description
Purpose of the research:
The aim of this study is to investigate the effect of aerobic exercise on neurophysiological values and functionality in individuals with multiple sclerosis.
The aim of this study is to determine whether aerobic exercise has positive effects on neurophysiological values and functionality in MS patients and to investigate this in a multidisciplinary and multidisciplinary manner.
Materials and Methods:
Patients with MS who were referred to the physiotherapy and rehabilitation program by the Physical Medicine and Rehabilitation specialist at Fırat University Training and Research Hospital will be included in the study.
In this study, patients with MS will be divided into two groups by stratified randomization method. Stratification will be performed in the early period of MS (EDSS 0.5-2.5) and in the late period of MS (EDSS 3-5.5). For a total of 18 sessions, only Frenkel Coordination exercises will be done to the control group, and Frenkel Coordination exercises and aerobic exercise will be applied to the study group.
Physiotherapy and Rehabilitation Program Control Group: Patients will receive Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) for 6 weeks. There will be a 1 minute break between each exercise set.
Study Group: Patients will receive Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) for 6 weeks. There will be a 1 minute break between each exercise set. Following this, an aerobic exercise of 30 minutes will be performed on the bicycle ergometer with electronic brake. Subjects will be advised not to do any exercise two days before or on that day and to eat only a light meal at least two hours before the test. The intensity of the exercise will be adjusted based on maximum oxygen consumption (VO2 max) specific to each individual.
Each exercise session;
- 5 min warm-up = 30% of VO2 max
- 20 min exercise = 50-60% of VO2 max
- 5 minutes cooling in the form. The goal of aerobic exercise is to increase physical capacity, which is represented by maximum oxygen uptake (VO2max) and mechanical power generated during exercise. Training programs should be conducted at least 2 to 3 times per week (60-80% maximum work rate or 60% VO2max) for 30 to 60 minutes at moderate concentrations. These programs are effective in increasing aerobic capacity and power output in MS (16).
Oxygen consumption (VO2), exhaled carbon dioxide (VCO2), minute ventilation (VE), respiratory rate (RR), respiration change rate (RER) and oxygen saturation (SaO2) will be recorded.
Evaluation Protocol:
Electromyography (EMG), max VO2 values and iris levels are analyzed before and after treatment and scales and questionnaires will be applied to evaluate the functional levels.
Within the scope of EMG evaluation, motor and sensory conduction studies of ulnar and median nerve in upper extremity, peroneal and tibial nerve in lower extremity, F response and H-reflex study in motor nerves, sensory conduction study of sural nerve in lower extremity are planned. H reflex is a monosynaptic reflection carried by 1a sensory fibers that synapse with alpha motor neuron. Response F shows the repeated discharges of alpha motor neurons and is a test used for the evaluation of diseases that cause transmission slowdown.
The VO2 max measurement will be performed using the incremental exercise test to determine the maximum aerobic capacity. After resting for 5 minutes (sitting on the ergometer), patients will be asked to start cycling on the ergometer starting at 25W. The load will be increased by 25W every 3 minutes until depletion. Subjects will be encouraged to continue the exercise as much as possible orally. Oxygen consumption (VO2), exhaled carbon dioxide (VCO2), minute ventilation (VE), respiration rate (RR), respiration change rate (RER), oxygen saturation (SaO2) and heart rate will be recorded. In the statistical analysis, only VO2 max values will be examined.
For the analysis of the level of iris, blood samples will be taken from gel biochemistry tubes as appropriate for the analyzes to be performed from the patients at the end of the aerobic capacity assessment. Blood samples will be separated by centrifugation at 3000rpm for 10min and the obtained sera will be placed in small portions in ependorf tubes and stored at -80 ° C until analysis. Irisin levels will be studied using commercial ELISA (enzyme-linked immunosorbent assay) kits in accordance with the kit user manual.
Multiple Sclerosis Functional Composite (MSFC), Ataxia Assessment and Rating Scale (SARA), Modified Borg Scale (MBS) to determine the effect of aerobic exercise on functionality in individuals with MS , Fatigue Impact Scale (FIS), Leeds Multiple Sclerosis Quality of Life Scale (Leeds Multiple Sclerosis Quality of L)
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, FNDC5, Irisin Hormone, Aerobic Exercise, EMG: Axonal Abnormality
- Being tested
- Aerobic Exercise, Frenkel coordination exercises
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Each exercise session;
- 5 min warm-up = 30% of VO2 max
- 20 min exercise = 50-60% of VO2 max
- 5 minutes cooling in the form. The goal of aerobic exercise is to increase physical capacity, which is represented by maximum oxygen uptake (VO2max) and mechanical power generated during exercise. Training programs should be conducted at least 2 to 3 times per week (60-80% maximum work rate or 60% VO2max) for 30 to 60 minutes at moderate concentrations. These programs are effective in increasing aerobic capacity and power output in MS.
Frenkel coordination exercisesOther
Patients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. 1 minute break between each exercise set
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise+Frenkel coordination Study group | Experimental | Patients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. There will be a 1 minute break between each exercise set. Following this, an aerobic exercise of 30 minutes will be performed on the bicycle ergometer with electronic brake. Subjects will be advised not to do any exercise two days before or on that day and to eat only a light meal at least two hours before the test. The intensity of the exercise will be adjusted based on maximum oxygen consumption (VO2 max) specific to each individual. Receives: Other: Aerobic Exercise; Other: Frenkel coordination exercises |
| Frenkel coordination exercise group - Control group | Active comparator | Patients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. There will be a 1 minute break between each exercise set. Receives: Other: Frenkel coordination exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological - Irisin Hormone
For the analysis of the level of iris, blood samples will be taken from gel biochemistry tubes as appropriate for the analyzes to be performed from the patients at the end of the aerobic capacity assessment. Blood samples will be separated by centrifugation at 3000rpm for 10min and the obtained sera will be placed in small portions in ependorf tubes and stored at -80 ° C until analysis. Irisin levels will be studied in accordance with the kit user manual using commercial ELISA (enzyme-linked immunosorbent assay) kits
Measured: 8 mounth
Neurophysiological - EMG
In the scope of EMG evaluation, the motor and sensory conduction studies of the ulnar and median nerve in the upper extremity, the peroneal and tibial nerves in the lower extremity, the F response and H-reflex study in the motor nerves, and the sensory conduction study of the sural nerve in the lower extremity are planned.
Measured: 8 mounth
VO2 Max
The VO2 max measurement will be performed using the incremental exercise test to determine the maximum aerobic capacity. After resting for 5 minutes (sitting on the ergometer), patients will be asked to start cycling on the ergometer starting at 25W. The load will be increased by 25W every 3 minutes until depletion.
Measured: 8 mounth
Secondary outcomes (3)
Multiple Sclerosis Functional Composites (MSFC)
Multiple Sclerosis Functional Composites (MSFC) was developed by the National MS Society's Clinical Outcomes Assessment Task Force. Objective assessment of functional disability score and help to maintain the standard of patient follow-up. It consists of 25 Step Walk Test, 9 Hole Peg Test, Step Auditory Serial Addition Test (PASAT) subtests. PASAT is used to measure the speed of auditory information processing, computational skills and attention from executive functions. It has two forms, A and B, and is performed with a standard voice recording. Each form has two subtests. In the first subtest, the numbers are repeated at three-second intervals, and the patient is expected to add the next number he heard. Each time, the patient must add the previous and the new number. 9 Perforated Peg Test is a test that measures upper extremity functions (hand and arm) and motor speed.
Measured: 8 mounth
Ataxia Scale (SARA)
The Ataxia Scale (SARA) is a scale used to assess ataxia including clinical dysfunction, limb movements, kinetic functions, posture and gait disorders, speech and oculomotor disorders. SARA subscores are posture and gait, speech, kinetic functions of the extremities
Measured: 8 mounth
Leeds Multiple Sclerosis Quality of Life Scale (LMSQoL)
The Leeds Multiple Sclerosis Quality of Life Scale (LMSQoL) was developed to assess the quality of life of individuals with MS. The eight-item form of this scale is directed towards fatigue, loneliness, energy, health concerns, family relationships, appearances, other people's attitudes, and the future. It is stated that LMSQoL is sensitive and reliable for the studied population and it is fast and easy to use in the clinical setting.
Measured: 8 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start21 Oct 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group Working group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Furkan BİLEK, Firat University
- Investigators
- Nilüfer ÇETİŞLİ KORKMAZ, Principal investigator, Pamukkale UniversityZübeyde ERCAN, Principal investigator, Firat UniversityGökhan ALKAN, Principal investigator, Firat UniversityMurat GÖNEN, Principal investigator, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121637
- Sponsor's protocol ID
- FiratUniversity
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frohman EM, Racke MK, Raine CS. Multiple sclerosis--the plaque and its pathogenesis. N Engl J Med. 2006 Mar 2;354(9):942-55. doi: 10.1056/NEJMra052130. No abstract available.
PubMed 16510748Lassmann H, Bruck W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol. 2007 Apr;17(2):210-8. doi: 10.1111/j.1750-3639.2007.00064.x.
PubMed 17388952Dalgas U, Stenager E. Progressive resistance therapy is not the best way to rehabilitate deficits due to multiple sclerosis: no. Mult Scler. 2014 Feb;20(2):141-2. doi: 10.1177/1352458513513060. No abstract available.
PubMed 24493702Rietberg MB, Brooks D, Uitdehaag BM, Kwakkel G. Exercise therapy for multiple sclerosis. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003980. doi: 10.1002/14651858.CD003980.pub2.
PubMed 15674920Motl RW, McAuley E, Snook EM. Physical activity and multiple sclerosis: a meta-analysis. Mult Scler. 2005 Aug;11(4):459-63. doi: 10.1191/1352458505ms1188oa.
PubMed 16042230Petajan JH, Gappmaier E, White AT, Spencer MK, Mino L, Hicks RW. Impact of aerobic training on fitness and quality of life in multiple sclerosis. Ann Neurol. 1996 Apr;39(4):432-41. doi: 10.1002/ana.410390405.
PubMed 8619521Sarova-Pinhas I, Achiron A, Gilad R, Lampl Y. Peripheral neuropathy in multiple sclerosis: a clinical and electrophysiologic study. Acta Neurol Scand. 1995 Apr;91(4):234-8. doi: 10.1111/j.1600-0404.1995.tb06996.x.
PubMed 7625146Ayromlou H, Mohammad-Khanli H, Yazdchi-Marandi M, Rikhtegar R, Zarrintan S, Golzari SE, Ghabili K. Electrodiagnostic evaluation of peripheral nervous system changes in patients with multiple sclerosis. Malays J Med Sci. 2013 Jul;20(4):32-8.
PubMed 24043994Armutlu K, Karabudak R, Nurlu G. Physiotherapy approaches in the treatment of ataxic multiple sclerosis: a pilot study. Neurorehabil Neural Repair. 2001;15(3):203-11. doi: 10.1177/154596830101500308.
PubMed 11944742Bostrom P, Wu J, Jedrychowski MP, Korde A, Ye L, Lo JC, Rasbach KA, Bostrom EA, Choi JH, Long JZ, Kajimura S, Zingaretti MC, Vind BF, Tu H, Cinti S, Hojlund K, Gygi SP, Spiegelman BM. A PGC1-alpha-dependent myokine that drives brown-fat-like development of white fat and thermogenesis. Nature. 2012 Jan 11;481(7382):463-8. doi: 10.1038/nature10777.
PubMed 22237023Wrann CD, White JP, Salogiannnis J, Laznik-Bogoslavski D, Wu J, Ma D, Lin JD, Greenberg ME, Spiegelman BM. Exercise induces hippocampal BDNF through a PGC-1alpha/FNDC5 pathway. Cell Metab. 2013 Nov 5;18(5):649-59. doi: 10.1016/j.cmet.2013.09.008. Epub 2013 Oct 10.
PubMed 24120943Moon HS, Dincer F, Mantzoros CS. Pharmacological concentrations of irisin increase cell proliferation without influencing markers of neurite outgrowth and synaptogenesis in mouse H19-7 hippocampal cell lines. Metabolism. 2013 Aug;62(8):1131-6. doi: 10.1016/j.metabol.2013.04.007. Epub 2013 May 7.
PubMed 23664146Novelle MG, Contreras C, Romero-Pico A, Lopez M, Dieguez C. Irisin, two years later. Int J Endocrinol. 2013;2013:746281. doi: 10.1155/2013/746281. Epub 2013 Nov 5.
PubMed 24298283Aydin S, Kuloglu T, Aydin S, Eren MN, Celik A, Yilmaz M, Kalayci M, Sahin I, Gungor O, Gurel A, Ogeturk M, Dabak O. Cardiac, skeletal muscle and serum irisin responses to with or without water exercise in young and old male rats: cardiac muscle produces more irisin than skeletal muscle. Peptides. 2014 Feb;52:68-73. doi: 10.1016/j.peptides.2013.11.024. Epub 2013 Dec 15.
PubMed 24345335Briken S, Rosenkranz SC, Keminer O, Patra S, Ketels G, Heesen C, Hellweg R, Pless O, Schulz KH, Gold SM. Effects of exercise on Irisin, BDNF and IL-6 serum levels in patients with progressive multiple sclerosis. J Neuroimmunol. 2016 Oct 15;299:53-58. doi: 10.1016/j.jneuroim.2016.08.007. Epub 2016 Aug 5.
PubMed 27725121
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effect of Aerobic Exercise on Neurophysiological Values and Functionality in Individuals With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT04121637
- Acronym / sponsor ID
- FiratUniversity
- Conditions
- Multiple Sclerosis, Relapsing-Remitting, FNDC5, Irisin Hormone, Aerobic Exercise, EMG: Axonal Abnormality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 21 Oct 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system, is characterized by myelin, oligodendrocytes and axon damage.
Physical exercises can be beneficial to patients, reduce fatigue and improve their strength, endurance and quality of life. Exercise has the potential to improve and / or preserve functionality, aerobic condition, strength, fatigue, health-related quality of life, depression, and cognition in MS patients. It has been reported that aerobic exercise increases muscle strength and endurance in peak oxygen intake and decreases fatigue and improves activity level, balance and walking patterns.
It is important to control the problems caused by ataxia in MS patients, to improve balance and postural reactions and to increase proximal muscle and trunk stabilization. For this purpose, movements are voluntarily and graded. Progress in exercises is achieved by making changes in the speed, width and complexity of movement. However, Frenkel Coordination exercises for extremity ataxia are usually included in the physiotherapy and rehabilitation program.
Little is known about the role and function of the iris in the nervous system with the discovery of Irisin and its precursor protein FNDC5. Evidence that the plasma level of iris increases during physical exercise suggests that it may also have beneficial and neuroprotective effects in the brain. Increased physical exercise has been shown to be associated with FNDC5 expression and ultimately more secretion of the iris.
The effect of elevated plasma iris levels after aerobic exercise on functionality in MS patients is unknown. Moon et al. Observed that cellular proliferation in mouse hippocampus cells was dose-dependent due to iris. In spraque dawley-type male rats, the presence of significant iris in the myelin sheath of the skeletal muscle shows that this tissue is an important source of iris. Based on these findings, it is thought that exercise-induced iris, which is an important cause of disability in MS, may have beneficial effects on the recovery of normal function in these patients. Whether iris affects nerve conduction velocity will be determined by electromyography analysis before and after aerobic exercise. In addition, the relationship between aerobic exercise and motor and sensory function and iris will be investigated and evaluated with functional tests.
Detailed description
Purpose of the research:
The aim of this study is to investigate the effect of aerobic exercise on neurophysiological values and functionality in individuals with multiple sclerosis.
The aim of this study is to determine whether aerobic exercise has positive effects on neurophysiological values and functionality in MS patients and to investigate this in a multidisciplinary and multidisciplinary manner.
Materials and Methods:
Patients with MS who were referred to the physiotherapy and rehabilitation program by the Physical Medicine and Rehabilitation specialist at Fırat University Training and Research Hospital will be included in the study.
In this study, patients with MS will be divided into two groups by stratified randomization method. Stratification will be performed in the early period of MS (EDSS 0.5-2.5) and in the late period of MS (EDSS 3-5.5). For a total of 18 sessions, only Frenkel Coordination exercises will be done to the control group, and Frenkel Coordination exercises and aerobic exercise will be applied to the study group.
Physiotherapy and Rehabilitation Program Control Group: Patients will receive Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) for 6 weeks. There will be a 1 minute break between each exercise set.
Study Group: Patients will receive Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) for 6 weeks. There will be a 1 minute break between each exercise set. Following this, an aerobic exercise of 30 minutes will be performed on the bicycle ergometer with electronic brake. Subjects will be advised not to do any exercise two days before or on that day and to eat only a light meal at least two hours before the test. The intensity of the exercise will be adjusted based on maximum oxygen consumption (VO2 max) specific to each individual.
Each exercise session;
- 5 min warm-up = 30% of VO2 max
- 20 min exercise = 50-60% of VO2 max
- 5 minutes cooling in the form. The goal of aerobic exercise is to increase physical capacity, which is represented by maximum oxygen uptake (VO2max) and mechanical power generated during exercise. Training programs should be conducted at least 2 to 3 times per week (60-80% maximum work rate or 60% VO2max) for 30 to 60 minutes at moderate concentrations. These programs are effective in increasing aerobic capacity and power output in MS (16).
Oxygen consumption (VO2), exhaled carbon dioxide (VCO2), minute ventilation (VE), respiratory rate (RR), respiration change rate (RER) and oxygen saturation (SaO2) will be recorded.
Evaluation Protocol:
Electromyography (EMG), max VO2 values and iris levels are analyzed before and after treatment and scales and questionnaires will be applied to evaluate the functional levels.
Within the scope of EMG evaluation, motor and sensory conduction studies of ulnar and median nerve in upper extremity, peroneal and tibial nerve in lower extremity, F response and H-reflex study in motor nerves, sensory conduction study of sural nerve in lower extremity are planned. H reflex is a monosynaptic reflection carried by 1a sensory fibers that synapse with alpha motor neuron. Response F shows the repeated discharges of alpha motor neurons and is a test used for the evaluation of diseases that cause transmission slowdown.
The VO2 max measurement will be performed using the incremental exercise test to determine the maximum aerobic capacity. After resting for 5 minutes (sitting on the ergometer), patients will be asked to start cycling on the ergometer starting at 25W. The load will be increased by 25W every 3 minutes until depletion. Subjects will be encouraged to continue the exercise as much as possible orally. Oxygen consumption (VO2), exhaled carbon dioxide (VCO2), minute ventilation (VE), respiration rate (RR), respiration change rate (RER), oxygen saturation (SaO2) and heart rate will be recorded. In the statistical analysis, only VO2 max values will be examined.
For the analysis of the level of iris, blood samples will be taken from gel biochemistry tubes as appropriate for the analyzes to be performed from the patients at the end of the aerobic capacity assessment. Blood samples will be separated by centrifugation at 3000rpm for 10min and the obtained sera will be placed in small portions in ependorf tubes and stored at -80 ° C until analysis. Irisin levels will be studied using commercial ELISA (enzyme-linked immunosorbent assay) kits in accordance with the kit user manual.
Multiple Sclerosis Functional Composite (MSFC), Ataxia Assessment and Rating Scale (SARA), Modified Borg Scale (MBS) to determine the effect of aerobic exercise on functionality in individuals with MS , Fatigue Impact Scale (FIS), Leeds Multiple Sclerosis Quality of Life Scale (Leeds Multiple Sclerosis Quality of L)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Control group Working group
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise+Frenkel coordination Study group | Experimental | Other: Aerobic Exercise, Other: Frenkel coordination exercisesPatients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. There will be a 1 minute break between each exercise set. Following this, an aerobic exercise of 30 minutes will be performed on the bicycle ergometer with electronic brake. Subjects will be advised not to do any exercise two days before or on that day and to eat only a light meal at least two hours before the test. The intensity of the exercise will be adjusted based on maximum oxygen consumption (VO2 max) specific to each individual. |
| Frenkel coordination exercise group - Control group | Active comparator | Other: Frenkel coordination exercisesPatients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. There will be a 1 minute break between each exercise set. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- EDSS score in the range of 0.5-5.5,
- Patients with relapsing-remitting type MS
- Patients diagnosed with MS who did not receive steroid therapy or were discontinued 3 months before starting the study.
Key exclusion criteria (7 listed)
- Has an acute MS attack or has a history of attacks in the last 3 months,
- Have orthopedic or systemic problems to prevent participation in the exercises,
- Another known neuromuscular disorder other than MS,
- Immunomodulatory therapy started in the last 6 months,
- Have visual involvement or diplopia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseEach exercise session; * 5 min warm-up = 30% of VO2 max * 20 min exercise = 50-60% of VO2 max * 5 minutes cooling in the form. The goal of aerobic exercise is to increase physical capacity, which is represented by maximum oxygen uptake (VO2max) and mechanical power generated during exercise. Training programs should be conducted at least 2 to 3 times per week (60-80% maximum work rate or 60% VO2max) for 30 to 60 minutes at moderate concentrations. These programs are effective in increasing aerobic capacity and power output in MS. | Other | Aerobic exercise+Frenkel coordination Study group |
| Frenkel coordination exercisesPatients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. 1 minute break between each exercise set | Other | Aerobic exercise+Frenkel coordination Study group, Frenkel coordination exercise group - Control group |
Primary outcome
Physiological - Irisin Hormone
Time frame: 8 mounth
For the analysis of the level of iris, blood samples will be taken from gel biochemistry tubes as appropriate for the analyzes to be performed from the patients at the end of the aerobic capacity assessment. Blood samples will be separated by centrifugation at 3000rpm for 10min and the obtained sera will be placed in small portions in ependorf tubes and stored at -80 ° C until analysis. Irisin levels will be studied in accordance with the kit user manual using commercial ELISA (enzyme-linked immunosorbent assay) kits
Neurophysiological - EMG
Time frame: 8 mounth
In the scope of EMG evaluation, the motor and sensory conduction studies of the ulnar and median nerve in the upper extremity, the peroneal and tibial nerves in the lower extremity, the F response and H-reflex study in the motor nerves, and the sensory conduction study of the sural nerve in the lower extremity are planned.
VO2 Max
Time frame: 8 mounth
The VO2 max measurement will be performed using the incremental exercise test to determine the maximum aerobic capacity. After resting for 5 minutes (sitting on the ergometer), patients will be asked to start cycling on the ergometer starting at 25W. The load will be increased by 25W every 3 minutes until depletion.
3 secondary outcomes
Multiple Sclerosis Functional Composites (MSFC)
Time frame: 8 mounth
Ataxia Scale (SARA)
Time frame: 8 mounth
Leeds Multiple Sclerosis Quality of Life Scale (LMSQoL)
Time frame: 8 mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Background: PubMed 16510748Frohman EM, Racke MK, Raine CS. Multiple sclerosis--the plaque and its pathogenesis. N Engl J Med. 2006 Mar 2;354(9):942-55. doi: 10.1056/NEJMra052130. No abstract available.
- Background: PubMed 17388952Lassmann H, Bruck W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol. 2007 Apr;17(2):210-8. doi: 10.1111/j.1750-3639.2007.00064.x.
- Background: PubMed 24493702Dalgas U, Stenager E. Progressive resistance therapy is not the best way to rehabilitate deficits due to multiple sclerosis: no. Mult Scler. 2014 Feb;20(2):141-2. doi: 10.1177/1352458513513060. No abstract available.
- Background: PubMed 15674920Rietberg MB, Brooks D, Uitdehaag BM, Kwakkel G. Exercise therapy for multiple sclerosis. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003980. doi: 10.1002/14651858.CD003980.pub2.
- Background: PubMed 16042230Motl RW, McAuley E, Snook EM. Physical activity and multiple sclerosis: a meta-analysis. Mult Scler. 2005 Aug;11(4):459-63. doi: 10.1191/1352458505ms1188oa.
- Background: PubMed 8619521Petajan JH, Gappmaier E, White AT, Spencer MK, Mino L, Hicks RW. Impact of aerobic training on fitness and quality of life in multiple sclerosis. Ann Neurol. 1996 Apr;39(4):432-41. doi: 10.1002/ana.410390405.
- Background: PubMed 7625146Sarova-Pinhas I, Achiron A, Gilad R, Lampl Y. Peripheral neuropathy in multiple sclerosis: a clinical and electrophysiologic study. Acta Neurol Scand. 1995 Apr;91(4):234-8. doi: 10.1111/j.1600-0404.1995.tb06996.x.
- Background: PubMed 24043994Ayromlou H, Mohammad-Khanli H, Yazdchi-Marandi M, Rikhtegar R, Zarrintan S, Golzari SE, Ghabili K. Electrodiagnostic evaluation of peripheral nervous system changes in patients with multiple sclerosis. Malays J Med Sci. 2013 Jul;20(4):32-8.
- Background: PubMed 11944742Armutlu K, Karabudak R, Nurlu G. Physiotherapy approaches in the treatment of ataxic multiple sclerosis: a pilot study. Neurorehabil Neural Repair. 2001;15(3):203-11. doi: 10.1177/154596830101500308.
- Background: PubMed 22237023Bostrom P, Wu J, Jedrychowski MP, Korde A, Ye L, Lo JC, Rasbach KA, Bostrom EA, Choi JH, Long JZ, Kajimura S, Zingaretti MC, Vind BF, Tu H, Cinti S, Hojlund K, Gygi SP, Spiegelman BM. A PGC1-alpha-dependent myokine that drives brown-fat-like development of white fat and thermogenesis. Nature. 2012 Jan 11;481(7382):463-8. doi: 10.1038/nature10777.
- Background: PubMed 24120943Wrann CD, White JP, Salogiannnis J, Laznik-Bogoslavski D, Wu J, Ma D, Lin JD, Greenberg ME, Spiegelman BM. Exercise induces hippocampal BDNF through a PGC-1alpha/FNDC5 pathway. Cell Metab. 2013 Nov 5;18(5):649-59. doi: 10.1016/j.cmet.2013.09.008. Epub 2013 Oct 10.
- Background: PubMed 23664146Moon HS, Dincer F, Mantzoros CS. Pharmacological concentrations of irisin increase cell proliferation without influencing markers of neurite outgrowth and synaptogenesis in mouse H19-7 hippocampal cell lines. Metabolism. 2013 Aug;62(8):1131-6. doi: 10.1016/j.metabol.2013.04.007. Epub 2013 May 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilüfer ÇETİŞLİ KORKMAZ principal investigator
Pamukkale University
Zübeyde ERCAN principal investigator
Firat University
Gökhan ALKAN principal investigator
Firat University
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Frenkel coordination exercises in people with Multiple Sclerosis, Relapsing-Remitting and FNDC5, run by Firat University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Furkan BİLEK, Ph. D. (0090 5442772249, fzt.furkanbilek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological - Irisin Hormone (time frame: 8 mounth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121637, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.