Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374108
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-16
Brief Title:
Resistance Training and Corticospinal Excitability in Multiple Sclerosis
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Effects of Supervised Progressive Resistance Training on Central Nervous System Functioning Corticospinal Excitability and Walking Capacity in Persons With Multiple Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
NEXIMS
Brief Summary:
The goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning corticospinal excitability CSE and walking capacity in persons with multiple sclerosis pwMS A total of 54 pwMS will be enrolled and randomized into 1 of 3 groups high dose resistant training RT low dose RT and waitlist control
Detailed Description:
Neurodegeneration is a hallmark of multiple sclerosis MS affecting both structure and function of the central nervous system CNS Neurodegeneration is the main driver of disability progression in MS evidenced by studies showing deleterious structural and functional CNS changes ultimately reducing quality of life Consequently the interaction between the nervous system and muscular system undergoes deleterious changes causing reduced neuromuscular function ie ability to develop muscle strength and power and physical function
The functional CNS changes have been evidenced by using the non invasive brain stimulation technique Transcranial Magnetic Stimulation showing decreased corticospinal excitability alongside increased central motor conduction time Moreover functional peripheral nervous system PNS changes have been evidenced by nerve conduction methods revealing decreased amplitude of compound muscle action potential and increased latency of nerve signaling In an ongoing exploratory study unpublished the investigators have observed that functional CNS and PNS outcomes deteriorate with disability progression from healthy to mildly to moderately disabled people with MS PwMS
Exercise is beneficial from both an individual and a societal perspective and has proven to be both safe and without any noticeable side effects in PwMS Resistance training RT appears particularly effective in improving neuromuscular function mainly muscle strength and physical function especially walking capacity Whilst RT and other exercise modalities may elicit positive effects on CNS structure in PwMS it seems to require a long-term 6 months exposure In contrast CNS and potentially PNS function may adapt much more rapidly despite a scarcity of studies and with heterogeneous findings involving PwMS Interestingly an exploratory exercise study non-controlled low sample size 10 weeks treadmill walking intervention assessed corticospinal excitability in PwMS and observed substantial improvements after the intervention Apart from this study a major knowledge gap exists in terms of elucidating the potential beneficial effects of exercise RT in particular on CNS and PNS function Based on evidence from healthy young individuals substantial improvements in corticospinal excitability have been shown following 2-12 weeks of RT supporting that RT-induced improvements in corticospinal excitability can also be seen in PwMS Lastly as existing exercise guidelines for PwMS fails to refer to evidence on dose-response to exercise and a recent systematic review on exercise studies found no dose-response studies in PwMS n202 this aspect is also of great clinical relevance
The functional CNS changes have been evidenced by using the non invasive brain stimulation technique Transcranial Magnetic Stimulation showing decreased corticospinal excitability alongside increased central motor conduction time Moreover functional peripheral nervous system PNS changes have been evidenced by nerve conduction methods revealing decreased amplitude of compound muscle action potential and increased latency of nerve signaling In an ongoing exploratory study unpublished the investigators have observed that functional CNS and PNS outcomes deteriorate with disability progression from healthy to mildly to moderately disabled people with MS PwMS
Exercise is beneficial from both an individual and a societal perspective and has proven to be both safe and without any noticeable side effects in PwMS Resistance training RT appears particularly effective in improving neuromuscular function mainly muscle strength and physical function especially walking capacity Whilst RT and other exercise modalities may elicit positive effects on CNS structure in PwMS it seems to require a long-term 6 months exposure In contrast CNS and potentially PNS function may adapt much more rapidly despite a scarcity of studies and with heterogeneous findings involving PwMS Interestingly an exploratory exercise study non-controlled low sample size 10 weeks treadmill walking intervention assessed corticospinal excitability in PwMS and observed substantial improvements after the intervention Apart from this study a major knowledge gap exists in terms of elucidating the potential beneficial effects of exercise RT in particular on CNS and PNS function Based on evidence from healthy young individuals substantial improvements in corticospinal excitability have been shown following 2-12 weeks of RT supporting that RT-induced improvements in corticospinal excitability can also be seen in PwMS Lastly as existing exercise guidelines for PwMS fails to refer to evidence on dose-response to exercise and a recent systematic review on exercise studies found no dose-response studies in PwMS n202 this aspect is also of great clinical relevance
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