Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05544994
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2022-08-19
Brief Title:
The Effect of Aerobic Exercise Training in Patients With Type III Spinal Muscular Atrophy
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
The Effect of Aerobic Exercise Training in Patients With Type III Spinal Muscular Atrophy
Status:
RECRUITING
Status Verified Date:
2023-09
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:
In the last 10-15 years a better understanding of the pathophysiology and molecular genetics of SMA has led to the emergence of previously unavailable pharmacological and genetic treatmentsOne of these new treatments Nusinersen targets SMN2 which is a slightly different copy of SMN1 and increases SMN protein levels
Preclinical studies have provided evidence that neuroprotection is strongly formed with exercise significantly increasing motor neuron survival independent of SMN expression
In a limited number of clinical studies prior to Nusinersen treatment it was reported that aerobic exercise training improved maximum oxygen uptake VO2 max without causing muscle damage but still caused fatigue
The aim of this study is to determine the effect of aerobic exercise training on motor and respiratory functions exercise capacity fatigue and quality of life in SMA Type III patients who can walk and receive Nusinersen therapy Twenty cases aged 10-50 years with genetically confirmed SMA diagnosis will be included in this study The cases to be included in the study will be randomized into 2 groups as the training and control groups
In addition to the routine physiotherapy program medium-intensity Aerobic Exercise Training will be given to the study group for 12 weeks Before and 12 weeks after the training the cases will be evaluated with the Six Minute Walking Test Submaximal Exercise Test SMN protein level function and strength assessments FVC value fatigue and quality of life scales
In clinical trials the supporting evidence for aerobic interventions in SMA is limited
Additional studies on aerobic intervention parameters frequency intensity and duration are neededThe results of this study will determine the feasibility of aerobic exercise training and provide important guidance for the clinical management of SMA patients
Preclinical studies have provided evidence that neuroprotection is strongly formed with exercise significantly increasing motor neuron survival independent of SMN expression
In a limited number of clinical studies prior to Nusinersen treatment it was reported that aerobic exercise training improved maximum oxygen uptake VO2 max without causing muscle damage but still caused fatigue
The aim of this study is to determine the effect of aerobic exercise training on motor and respiratory functions exercise capacity fatigue and quality of life in SMA Type III patients who can walk and receive Nusinersen therapy Twenty cases aged 10-50 years with genetically confirmed SMA diagnosis will be included in this study The cases to be included in the study will be randomized into 2 groups as the training and control groups
In addition to the routine physiotherapy program medium-intensity Aerobic Exercise Training will be given to the study group for 12 weeks Before and 12 weeks after the training the cases will be evaluated with the Six Minute Walking Test Submaximal Exercise Test SMN protein level function and strength assessments FVC value fatigue and quality of life scales
In clinical trials the supporting evidence for aerobic interventions in SMA is limited
Additional studies on aerobic intervention parameters frequency intensity and duration are neededThe results of this study will determine the feasibility of aerobic exercise training and provide important guidance for the clinical management of SMA patients
Detailed Description:
Spinal Muscular Atrophy SMA is a neuromuscular disorder characterized by degeneration of alpha motor neurons in the spinal cord leading to progressive muscle atrophy and weakness Mutation or deletion of the survival motor neuron1 SMN1 gene causes insufficient production of the SMN protein which ensures motor neuron survival and maintenance in the spinal cord
In the last 10-15 years a better understanding of the pathophysiology and molecular genetics of SMA has led to the emergence of previously unavailable pharmacological and genetic treatments One of these new treatments Nusinersen targets SMN2 which is a slightly different copy of SMN1 increases SMN protein levels Preclinical studies have provided evidence that exercise significantly increases motor neuron survival independent of SMN expression and that neuroprotection is strongly formed In a limited number of clinical studies prior to Nuinersen therapy it was reported that aerobic exercise training improved maximum oxygen uptake VO2 max without causing muscle damage but still caused fatigue and had no significant beneficial effect on physical functioning This study aims to determine the effect of aerobic exercise training on motor and respiratory functions exercise capacity fatigue and quality of life in SMA Type III patients who can walk and receive Nusinersen treatment Twenty patients between the ages of 10 and 50 with genetically confirmed SMA diagnosis will be included in this study The patients will be randomly divided into 2 groups as the training and control groups In addition to the routine physiotherapy program the study group will be given a moderate-intensity Aerobic Exercise Training for 12 weeks Before and after 12 weeks of training subjects will be evaluated with the Six-Minute Walk Test Submaximal Exercise Test SMN protein level and function and strength assessments FVC value fatigue and quality of life scales
In clinical trials the supporting evidence for aerobic interventions in SMA is limited It has been reported that SMA patients cannot tolerate excessive exercise intensity and that recovery may be prevented due to excessive fatigue Additional studies on aerobic intervention parameters frequency intensity and duration are needed The results of this study will determine the feasibility of aerobic exercise training and will have an impact on clinical practice by providing important guidance to the clinical management of SMA patients
In the last 10-15 years a better understanding of the pathophysiology and molecular genetics of SMA has led to the emergence of previously unavailable pharmacological and genetic treatments One of these new treatments Nusinersen targets SMN2 which is a slightly different copy of SMN1 increases SMN protein levels Preclinical studies have provided evidence that exercise significantly increases motor neuron survival independent of SMN expression and that neuroprotection is strongly formed In a limited number of clinical studies prior to Nuinersen therapy it was reported that aerobic exercise training improved maximum oxygen uptake VO2 max without causing muscle damage but still caused fatigue and had no significant beneficial effect on physical functioning This study aims to determine the effect of aerobic exercise training on motor and respiratory functions exercise capacity fatigue and quality of life in SMA Type III patients who can walk and receive Nusinersen treatment Twenty patients between the ages of 10 and 50 with genetically confirmed SMA diagnosis will be included in this study The patients will be randomly divided into 2 groups as the training and control groups In addition to the routine physiotherapy program the study group will be given a moderate-intensity Aerobic Exercise Training for 12 weeks Before and after 12 weeks of training subjects will be evaluated with the Six-Minute Walk Test Submaximal Exercise Test SMN protein level and function and strength assessments FVC value fatigue and quality of life scales
In clinical trials the supporting evidence for aerobic interventions in SMA is limited It has been reported that SMA patients cannot tolerate excessive exercise intensity and that recovery may be prevented due to excessive fatigue Additional studies on aerobic intervention parameters frequency intensity and duration are needed The results of this study will determine the feasibility of aerobic exercise training and will have an impact on clinical practice by providing important guidance to the clinical management of SMA patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None