Multiple SclerosisNCT04944251
Regular Exercise Improves Physical Capacity and Promotes Neurotrophins in Patients With Multiple Sclerosis
A study testing Regular Exercise in people with Multiple Sclerosis and Exercise Intervention, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
ABSTRACT Objective: The investigators aimed to determine the effect of regular exercise on aerobic capacity, strength values, and plasma levels of nerve growth factor (NGF) and Neurotrophin-3 (NT-3) in patients with multiple sclerosis (MS), and investigate its effects on MS symptoms including cognitive impairment… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Exercise Intervention, Neuro-Degenerative Disease
- What is being tested?
- Regular Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 19 Jan 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A total of 53 relapsing remitting form MS (RRMS) patients between the ages of 18-55 years, diagnosed with definite MS according to 2017 McDonald criteria, and followed up in Ege University MS and Demyelinating Diseases Unit, without an MS attack in the last 3 months, had an EDSS score ≤ 4 that did not change with symptomatic or immunomodulatory treatments within 6 months were included in this prospective randomized controlled study.
Who cannot join
- Patients who did not meet the inclusion criteria were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise in Persons With Multiple Sclerosis
ABSTRACT
Objective:
Read more
The investigators aimed to determine the effect of regular exercise on aerobic capacity, strength values, and plasma levels of nerve growth factor (NGF) and Neurotrophin-3 (NT-3) in patients with multiple sclerosis (MS), and investigate its effects on MS symptoms including cognitive impairment, fatigue, balance disorders and quality of life.
Methods:
Forty-three relapsing-remitting MS (RRMS) patients with an EDSS score of 4 or less participated in the study. Participants were divided into 3 groups as aerobic exercise, strength exercise and control groups. The patients in the exercise groups had exercise programs 3 days a week, for 3 months. Aerobic capacity (maximum VO2 value), strength measurements and balance tests were done, and NGF and NT-3 plasma levels were analyzed in all participants at the beginning and end of the study. MSQoL54 quality of life, fatigue impact scale (FIS), Pittsburgh Sleep Quality Index (PSQI) and BICAMS scale were applied to evaluate cognitive functions.
Read the detailed description
INTRODUCTION Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disorder characterized by inflammation, demyelination, axonal damage and gliosis, particularly affecting white matter, and also gray matter 1. It is the most common disorder of the central nervous system (CNS) that causes neurological disability in young adults. Various degrees of physical and cognitive impairments are seen starting in the early period, and particularly in the progressive course of the disease 2.
Physical inactivity may lead to progressive muscle atrophy in MS patients due to insufficient neural stimulation to the muscles 6. In MS patients, maximal oxygen consumption (VO2 max), which is a marker of cardiorespiratory fitness and functional performance, has been shown to decrease 7. All of these conditions may lead to worsening of MS symptoms and fatigue, which may result in a vicious cycle and cause reduced physical activity and an impairment in quality of life.
Exercise has numerous neurobiological effects, including anatomical and physiological changes in the brains of healthy and unhealthy individuals 8. Exercise provides comprehensive alterations in cerebrovascular structures such as blood flow, nutrient delivery, development of angiogenesis and regeneration of blood vessels 9. These alterations facilitate neurogenesis, increase synaptic plasticity, and ultimately may improve brain health and MS-related symptoms 9. Neurotrophins (NT) are growth factors that provide the survival and hypertrophy of neurons, as well as neurogenesis and synaptic plasticity 10. They are synthesized by a number of cell types including peripheral nervous system neurons, peripheral tissues, and particularly in the CNS 11,12. It is believed that exercise activates molecules and cellular cascades that support and maintain brain plasticity, facilitates neurogenesis, and thus may be effective in neurodegenerative processes and cognitive disorders 13.
In this study, the investigators aimed to investigate the effect of regular exercise on aerobic capacity and strength values, and to determine whether exercise contributes to the improvement of cognitive, balance, and sleep disorders and fatigue, and quality of life in MS patients. The investigators also investigated post-exercise changes in the plasma levels of neurotrophins, nerve growth factor (NGF) and neurotrophin-3 (NT-3), which are important biomarkers in neural regeneration and re-myelination.
MATERIAL AND METHODS Study design A total of 53 relapsing remitting form MS (RRMS) patients between the ages of 18-55 years, diagnosed with definite MS according to 2017 McDonald criteria, and followed up in Ege University MS and Demyelinating Diseases Unit, without an MS attack in the last 3 months, had an EDSS score ≤ 4 that did not change with symptomatic or immunomodulatory treatments within 6 months were included in this prospective randomized controlled study. The procedures and possible side effects (such as exercise-related injuries and having an MS attack) were explained in detail to each participant candidate, and the "Informed Consent Form" was signed by the volunteers. "Ege University Clinical Research Ethics Committee" approved the study protocol (date: Apr 03, 2019, decree no: 19-4T/43).
The patients who participated in the study and wished to be included in the exercise group were randomly allocated to the aerobic exercise and strength exercise groups. The patients who didn't want to exercise were included in the control group. Four patients in the aerobic group and 6 patients in the strength group could not complete the study due to reasons such as knee pain (1), not attending exercise sessions regularly (8), and not attending control measurements (1).
Exercise Procedures:
The patients in the exercise groups carried out tailor-made exercise programs, under the supervision of a faculty member of the Faculty of Sports Sciences. It was paid attention to keep the temperature of the exercise room at 20°C. The control patients did not participate in any exercise or physical activity program.
In the first month, the patients in the aerobic group started to exercise at a heart rate corresponding to 60% of the maximal VO2, by adjusting the pedal resistance of the exercise bike, consistent with the Karvonen formula. This was followed by exercise cycling at a heart rate corresponding to 70% of maximal VO2 in the second month, and 80% of maximal VO2 in the third month, for 30 minutes, 3 days a week (Figure 1) 14.
The patients included in the strength exercise group performed weight training exercises involving 10 large muscle groups (leg press, chest press, leg curl, lateral pull down, leg extension, dumbbell lateral raise, calf press, upright row, sit up, quadruped arm opposite leg raise), 3 days a week; including 1 set of 12-15 repetitions in the first month, 2 sets of 12-15 repetitions in the second month, and 3 sets of 12-15 repetitions in the third month. Participants' working weights were set as 60% of the maximum weight they could lift.
- Being tested
- Regular Exercise
- Keywords
- multiple sclerosis, exercise, nerve growth factor, neurotrophin 3, cognition, quality of life
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular ExerciseBehavioural
the third month, for 30 minutes or 1 hour, 3 days a week
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise group | Experimental | the patients in the aerobic group started to exercise at a heart rate corresponding to 60% of the maximal VO2, by adjusting the pedal resistance of the exercise bike, consistent with the Karvonen formula. This was followed by exercise cycling at a heart rate corresponding to 70% of maximal VO2 in the second month, and 80% of maximal VO2 in the third month, for 30 minutes, 3 days a week Receives: Behavioral: Regular Exercise |
| strength exercise group | Experimental | The patients included in the strength exercise group performed weight training exercises involving 10 large muscle groups (leg press, chest press, leg curl, lateral pull down, leg extension, dumbbell lateral raise, calf press, upright row, sit up, quadruped arm opposite leg raise), 3 days a week; including 1 set of 12-15 repetitions in the first month, 2 sets of 12-15 repetitions in the second month, and 3 sets of 12-15 repetitions in the third month (Figure 1). Participants' working weights were set as 60% of the maximum weight they could lift. Receives: Behavioral: Regular Exercise |
| control group | No intervention | The patients who didn't want to exercise were included in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity assessment after exercise intervention
Measurement of Aerobic Capacity: Milliliters were used for the amount of oxygen used, kilograms were used for body weight, and minutes were used for time. the amount of oxygen consumed, weight and time will be combined to report aerobic capacity in ml/kg/min.
The unit of aerobic capacity, ml/kg/min, refers to the amount of oxygen the body consumes per kilogram per minute. The indirect Astrand test bicycle test protocol with Lode Corival bicycle ergometer was applied to all patients. The pedal resistance applied in the test and the mean pulse rate were marked in the Astrand normogram, and the aerobic capacities of the patients were calculated. It was observed that aerobic capacity (ml/kg/min) increased in exercise groups after regular exercise.
Measured: Each participant's progress will be tested at the beginning and end of the 12-week training period.
Strength assessment after exercise intervention
Strength Measurements: The kilogram-force (kg-f) is a non-standard Gravitational Metric unit of force. The kilogram-force is equal to the magnitude of the force exerted on one kilogram of mass in a 9.80665 m/s2 gravitational field. Kilogram was used for weight. The force is any influence that, when unopposed, will change the motion of an object. Weight and force will be combined to report strength in kg-f. Strength was examined with an isometric hand and backleg dynamometer in all patients. Strength was examined with an isometric hand and backleg dynamometer in all patients. Two measurements were made, at the beginning and at the end of the study. It was observed that strength values increased in exercise groups after regular exercise.
Measured: Each participant's progress will be tested at the beginning and end of the 12-week training period.
plasma neurotrophin values (pg/ml)
Plasma NGF and NT-3 levels were measured with an ELISA kit. Plasma neurotrophin values increased in exercise groups.
Measured: Each participant's progress will be tested at the beginning and end of the 12-week training period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Apr 2019
- Primary completion1 Dec 2019
- Study completion19 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized prospective study
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Acik, Ege University
- Investigators
- Mehmet ACIK, Dr, Principal investigator, Ege UniversitySeckin Senisik, Ass. Prof., Study director, Ege UniversityNur Yuceyar, Professor, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944251
- Sponsor's protocol ID
- 19-4T/43
- Status last verified
- Jun 2021
- First submitted
- 20 May 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For the continuity of scientific research, my data can be used for other researches.
Publications
Lassmann H. Pathogenic Mechanisms Associated With Different Clinical Courses of Multiple Sclerosis. Front Immunol. 2019 Jan 10;9:3116. doi: 10.3389/fimmu.2018.03116. eCollection 2018.
PubMed 30687321Oh J, Vidal-Jordana A, Montalban X. Multiple sclerosis: clinical aspects. Curr Opin Neurol. 2018 Dec;31(6):752-759. doi: 10.1097/WCO.0000000000000622.
PubMed 30300239Bamer AM, Johnson KL, Amtmann D, Kraft GH. Prevalence of sleep problems in individuals with multiple sclerosis. Mult Scler. 2008 Sep;14(8):1127-30. doi: 10.1177/1352458508092807. Epub 2008 Jul 16.
PubMed 18632776Mazumder R, Murchison C, Bourdette D, Cameron M. Falls in people with multiple sclerosis compared with falls in healthy controls. PLoS One. 2014 Sep 25;9(9):e107620. doi: 10.1371/journal.pone.0107620. eCollection 2014.
PubMed 25254633Benedict RH, Wahlig E, Bakshi R, Fishman I, Munschauer F, Zivadinov R, Weinstock-Guttman B. Predicting quality of life in multiple sclerosis: accounting for physical disability, fatigue, cognition, mood disorder, personality, and behavior change. J Neurol Sci. 2005 Apr 15;231(1-2):29-34. doi: 10.1016/j.jns.2004.12.009. Epub 2005 Jan 26.
PubMed 15792817Jorgensen M, Dalgas U, Wens I, Hvid LG. Muscle strength and power in persons with multiple sclerosis - A systematic review and meta-analysis. J Neurol Sci. 2017 May 15;376:225-241. doi: 10.1016/j.jns.2017.03.022. Epub 2017 Mar 18.
PubMed 28431618Phillips C, Baktir MA, Srivatsan M, Salehi A. Neuroprotective effects of physical activity on the brain: a closer look at trophic factor signaling. Front Cell Neurosci. 2014 Jun 20;8:170. doi: 10.3389/fncel.2014.00170. eCollection 2014.
PubMed 24999318Lange-Asschenfeldt C, Kojda G. Alzheimer's disease, cerebrovascular dysfunction and the benefits of exercise: from vessels to neurons. Exp Gerontol. 2008 Jun;43(6):499-504. doi: 10.1016/j.exger.2008.04.002. Epub 2008 Apr 6.
PubMed 18474414Vilar M, Mira H. Regulation of Neurogenesis by Neurotrophins during Adulthood: Expected and Unexpected Roles. Front Neurosci. 2016 Feb 9;10:26. doi: 10.3389/fnins.2016.00026. eCollection 2016.
PubMed 26903794Riley CP, Cope TC, Buck CR. CNS neurotrophins are biologically active and expressed by multiple cell types. J Mol Histol. 2004 Nov;35(8-9):771-83. doi: 10.1007/s10735-004-0778-9.
PubMed 15609090Yamamoto M, Sobue G, Yamamoto K, Terao S, Mitsuma T. Expression of mRNAs for neurotrophic factors (NGF, BDNF, NT-3, and GDNF) and their receptors (p75NGFR, trkA, trkB, and trkC) in the adult human peripheral nervous system and nonneural tissues. Neurochem Res. 1996 Aug;21(8):929-38. doi: 10.1007/BF02532343.
PubMed 8895847Cotman CW, Berchtold NC. Exercise: a behavioral intervention to enhance brain health and plasticity. Trends Neurosci. 2002 Jun;25(6):295-301. doi: 10.1016/s0166-2236(02)02143-4.
PubMed 12086747KARVONEN MJ, KENTALA E, MUSTALA O. The effects of training on heart rate; a longitudinal study. Ann Med Exp Biol Fenn. 1957;35(3):307-15. No abstract available.
PubMed 13470504Langeskov-Christensen M, Heine M, Kwakkel G, Dalgas U. Aerobic capacity in persons with multiple sclerosis: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):905-23. doi: 10.1007/s40279-015-0307-x.
PubMed 25739555Langeskov-Christensen M, Langeskov-Christensen D, Overgaard K, Moller AB, Dalgas U. Validity and reliability of VO(2)-max measurements in persons with multiple sclerosis. J Neurol Sci. 2014 Jul 15;342(1-2):79-87. doi: 10.1016/j.jns.2014.04.028. Epub 2014 Apr 27.
PubMed 24825731
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04944251
- Acronym / sponsor ID
- 19-4T/43
- Keywords
- multiple sclerosis, exercise, nerve growth factor, neurotrophin 3, cognition, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 19 Jan 2020 (actual)
- First posted
- 29 Jun 2021 (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.
ABSTRACT
Objective:
The investigators aimed to determine the effect of regular exercise on aerobic capacity, strength values, and plasma levels of nerve growth factor (NGF) and Neurotrophin-3 (NT-3) in patients with multiple sclerosis (MS), and investigate its effects on MS symptoms including cognitive impairment, fatigue, balance disorders and quality of life.
Methods:
Forty-three relapsing-remitting MS (RRMS) patients with an EDSS score of 4 or less participated in the study. Participants were divided into 3 groups as aerobic exercise, strength exercise and control groups. The patients in the exercise groups had exercise programs 3 days a week, for 3 months. Aerobic capacity (maximum VO2 value), strength measurements and balance tests were done, and NGF and NT-3 plasma levels were analyzed in all participants at the beginning and end of the study. MSQoL54 quality of life, fatigue impact scale (FIS), Pittsburgh Sleep Quality Index (PSQI) and BICAMS scale were applied to evaluate cognitive functions.
Detailed description
INTRODUCTION Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disorder characterized by inflammation, demyelination, axonal damage and gliosis, particularly affecting white matter, and also gray matter 1. It is the most common disorder of the central nervous system (CNS) that causes neurological disability in young adults. Various degrees of physical and cognitive impairments are seen starting in the early period, and particularly in the progressive course of the disease 2.
Physical inactivity may lead to progressive muscle atrophy in MS patients due to insufficient neural stimulation to the muscles 6. In MS patients, maximal oxygen consumption (VO2 max), which is a marker of cardiorespiratory fitness and functional performance, has been shown to decrease 7. All of these conditions may lead to worsening of MS symptoms and fatigue, which may result in a vicious cycle and cause reduced physical activity and an impairment in quality of life.
Exercise has numerous neurobiological effects, including anatomical and physiological changes in the brains of healthy and unhealthy individuals 8. Exercise provides comprehensive alterations in cerebrovascular structures such as blood flow, nutrient delivery, development of angiogenesis and regeneration of blood vessels 9. These alterations facilitate neurogenesis, increase synaptic plasticity, and ultimately may improve brain health and MS-related symptoms 9. Neurotrophins (NT) are growth factors that provide the survival and hypertrophy of neurons, as well as neurogenesis and synaptic plasticity 10. They are synthesized by a number of cell types including peripheral nervous system neurons, peripheral tissues, and particularly in the CNS 11,12. It is believed that exercise activates molecules and cellular cascades that support and maintain brain plasticity, facilitates neurogenesis, and thus may be effective in neurodegenerative processes and cognitive disorders 13.
In this study, the investigators aimed to investigate the effect of regular exercise on aerobic capacity and strength values, and to determine whether exercise contributes to the improvement of cognitive, balance, and sleep disorders and fatigue, and quality of life in MS patients. The investigators also investigated post-exercise changes in the plasma levels of neurotrophins, nerve growth factor (NGF) and neurotrophin-3 (NT-3), which are important biomarkers in neural regeneration and re-myelination.
MATERIAL AND METHODS Study design A total of 53 relapsing remitting form MS (RRMS) patients between the ages of 18-55 years, diagnosed with definite MS according to 2017 McDonald criteria, and followed up in Ege University MS and Demyelinating Diseases Unit, without an MS attack in the last 3 months, had an EDSS score ≤ 4 that did not change with symptomatic or immunomodulatory treatments within 6 months were included in this prospective randomized controlled study. The procedures and possible side effects (such as exercise-related injuries and having an MS attack) were explained in detail to each participant candidate, and the "Informed Consent Form" was signed by the volunteers. "Ege University Clinical Research Ethics Committee" approved the study protocol (date: Apr 03, 2019, decree no: 19-4T/43).
The patients who participated in the study and wished to be included in the exercise group were randomly allocated to the aerobic exercise and strength exercise groups. The patients who didn't want to exercise were included in the control group. Four patients in the aerobic group and 6 patients in the strength group could not complete the study due to reasons such as knee pain (1), not attending exercise sessions regularly (8), and not attending control measurements (1).
Exercise Procedures:
The patients in the exercise groups carried out tailor-made exercise programs, under the supervision of a faculty member of the Faculty of Sports Sciences. It was paid attention to keep the temperature of the exercise room at 20°C. The control patients did not participate in any exercise or physical activity program.
In the first month, the patients in the aerobic group started to exercise at a heart rate corresponding to 60% of the maximal VO2, by adjusting the pedal resistance of the exercise bike, consistent with the Karvonen formula. This was followed by exercise cycling at a heart rate corresponding to 70% of maximal VO2 in the second month, and 80% of maximal VO2 in the third month, for 30 minutes, 3 days a week (Figure 1) 14.
The patients included in the strength exercise group performed weight training exercises involving 10 large muscle groups (leg press, chest press, leg curl, lateral pull down, leg extension, dumbbell lateral raise, calf press, upright row, sit up, quadruped arm opposite leg raise), 3 days a week; including 1 set of 12-15 repetitions in the first month, 2 sets of 12-15 repetitions in the second month, and 3 sets of 12-15 repetitions in the third month. Participants' working weights were set as 60% of the maximum weight they could lift.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise group | Experimental | Behavioral: Regular Exercisethe patients in the aerobic group started to exercise at a heart rate corresponding to 60% of the maximal VO2, by adjusting the pedal resistance of the exercise bike, consistent with the Karvonen formula. This was followed by exercise cycling at a heart rate corresponding to 70% of maximal VO2 in the second month, and 80% of maximal VO2 in the third month, for 30 minutes, 3 days a week |
| strength exercise group | Experimental | Behavioral: Regular ExerciseThe patients included in the strength exercise group performed weight training exercises involving 10 large muscle groups (leg press, chest press, leg curl, lateral pull down, leg extension, dumbbell lateral raise, calf press, upright row, sit up, quadruped arm opposite leg raise), 3 days a week; including 1 set of 12-15 repetitions in the first month, 2 sets of 12-15 repetitions in the second month, and 3 sets of 12-15 repetitions in the third month (Figure 1). Participants' working weights were set as 60% of the maximum weight they could lift. |
| control group | No intervention | –The patients who didn't want to exercise were included in the control group. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A total of 53 relapsing remitting form MS (RRMS) patients between the ages of 18-55 years, diagnosed with definite MS according to 2017 McDonald criteria, and followed up in Ege University MS and Demyelinating Diseases Unit, without an MS attack in the last 3 months, had an EDSS score ≤ 4 that did not change with symptomatic or immunomodulatory treatments within 6 months were included in this prospective randomized controlled study.
Key exclusion criteria (1 listed)
- Patients who did not meet the inclusion criteria were excluded from the study.
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 |
|---|---|---|
| Regular Exercisethe third month, for 30 minutes or 1 hour, 3 days a week | Behavioural | aerobic exercise group, strength exercise group |
Primary outcome
Aerobic capacity assessment after exercise intervention
Time frame: Each participant's progress will be tested at the beginning and end of the 12-week training period.
Measurement of Aerobic Capacity: Milliliters were used for the amount of oxygen used, kilograms were used for body weight, and minutes were used for time. the amount of oxygen consumed, weight and time will be combined to report aerobic capacity in ml/kg/min. The unit of aerobic capacity, ml/kg/min, refers to the amount of oxygen the body consumes per kilogram per minute. The indirect Astrand test bicycle test protocol with Lode Corival bicycle ergometer was applied to all patients. The pedal resistance applied in the test and the mean pulse rate were marked in the Astrand normogram, and the aerobic capacities of the patients were calculated. It was observed that aerobic capacity (ml/kg/min) increased in exercise groups after regular exercise.
Strength assessment after exercise intervention
Time frame: Each participant's progress will be tested at the beginning and end of the 12-week training period.
Strength Measurements: The kilogram-force (kg-f) is a non-standard Gravitational Metric unit of force. The kilogram-force is equal to the magnitude of the force exerted on one kilogram of mass in a 9.80665 m/s2 gravitational field. Kilogram was used for weight. The force is any influence that, when unopposed, will change the motion of an object. Weight and force will be combined to report strength in kg-f. Strength was examined with an isometric hand and backleg dynamometer in all patients. Strength was examined with an isometric hand and backleg dynamometer in all patients. Two measurements were made, at the beginning and at the end of the study. It was observed that strength values increased in exercise groups after regular exercise.
plasma neurotrophin values (pg/ml)
Time frame: Each participant's progress will be tested at the beginning and end of the 12-week training period.
Plasma NGF and NT-3 levels were measured with an ELISA kit. Plasma neurotrophin values increased in exercise groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Background: PubMed 30687321Lassmann H. Pathogenic Mechanisms Associated With Different Clinical Courses of Multiple Sclerosis. Front Immunol. 2019 Jan 10;9:3116. doi: 10.3389/fimmu.2018.03116. eCollection 2018.
- Background: PubMed 30300239Oh J, Vidal-Jordana A, Montalban X. Multiple sclerosis: clinical aspects. Curr Opin Neurol. 2018 Dec;31(6):752-759. doi: 10.1097/WCO.0000000000000622.
- Background: PubMed 18632776Bamer AM, Johnson KL, Amtmann D, Kraft GH. Prevalence of sleep problems in individuals with multiple sclerosis. Mult Scler. 2008 Sep;14(8):1127-30. doi: 10.1177/1352458508092807. Epub 2008 Jul 16.
- Background: PubMed 25254633Mazumder R, Murchison C, Bourdette D, Cameron M. Falls in people with multiple sclerosis compared with falls in healthy controls. PLoS One. 2014 Sep 25;9(9):e107620. doi: 10.1371/journal.pone.0107620. eCollection 2014.
- Background: PubMed 15792817Benedict RH, Wahlig E, Bakshi R, Fishman I, Munschauer F, Zivadinov R, Weinstock-Guttman B. Predicting quality of life in multiple sclerosis: accounting for physical disability, fatigue, cognition, mood disorder, personality, and behavior change. J Neurol Sci. 2005 Apr 15;231(1-2):29-34. doi: 10.1016/j.jns.2004.12.009. Epub 2005 Jan 26.
- Background: PubMed 28431618Jorgensen M, Dalgas U, Wens I, Hvid LG. Muscle strength and power in persons with multiple sclerosis - A systematic review and meta-analysis. J Neurol Sci. 2017 May 15;376:225-241. doi: 10.1016/j.jns.2017.03.022. Epub 2017 Mar 18.
- Background: PubMed 24999318Phillips C, Baktir MA, Srivatsan M, Salehi A. Neuroprotective effects of physical activity on the brain: a closer look at trophic factor signaling. Front Cell Neurosci. 2014 Jun 20;8:170. doi: 10.3389/fncel.2014.00170. eCollection 2014.
- Background: PubMed 18474414Lange-Asschenfeldt C, Kojda G. Alzheimer's disease, cerebrovascular dysfunction and the benefits of exercise: from vessels to neurons. Exp Gerontol. 2008 Jun;43(6):499-504. doi: 10.1016/j.exger.2008.04.002. Epub 2008 Apr 6.
- Background: PubMed 26903794Vilar M, Mira H. Regulation of Neurogenesis by Neurotrophins during Adulthood: Expected and Unexpected Roles. Front Neurosci. 2016 Feb 9;10:26. doi: 10.3389/fnins.2016.00026. eCollection 2016.
- Background: PubMed 15609090Riley CP, Cope TC, Buck CR. CNS neurotrophins are biologically active and expressed by multiple cell types. J Mol Histol. 2004 Nov;35(8-9):771-83. doi: 10.1007/s10735-004-0778-9.
- Background: PubMed 8895847Yamamoto M, Sobue G, Yamamoto K, Terao S, Mitsuma T. Expression of mRNAs for neurotrophic factors (NGF, BDNF, NT-3, and GDNF) and their receptors (p75NGFR, trkA, trkB, and trkC) in the adult human peripheral nervous system and nonneural tissues. Neurochem Res. 1996 Aug;21(8):929-38. doi: 10.1007/BF02532343.
- Background: PubMed 12086747Cotman CW, Berchtold NC. Exercise: a behavioral intervention to enhance brain health and plasticity. Trends Neurosci. 2002 Jun;25(6):295-301. doi: 10.1016/s0166-2236(02)02143-4.
- Results ReferenceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. For the continuity of scientific research, my data can be used for other researches.
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Multiple Sclerosis
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.
Mehmet ACIK, Dr principal investigator
Ege University
Seckin Senisik, Ass. Prof. study director
Ege University
Nur Yuceyar, Professor study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Exercise in people with Multiple Sclerosis and Exercise Intervention, run by Ege University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity assessment after exercise intervention (time frame: Each participant's progress will be tested at the beginning and end of the 12-week training period.). 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 NCT04944251, which also lists 34 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 29 Jun 2021.