Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368076
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-02-29
Brief Title:
High-intensity Interval Training in Patients With Spinal Muscular Atrophy
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
High-intensity Interval Training in Patients With Spinal Muscular Atrophy
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain reduced sleep quality constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate However only very little research has been done on exercise for patients who are wheelchair users The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy
Detailed Description:
Spinal muscular atrophy SMA is a neuromuscular disease affecting the motor neurons of the spinal cord that innervate the skeletal muscles leading to progressive muscle atrophy and weakness Consequently many patients end up having to use a wheelchair from an early age
Besides the impaired motor function patients with SMA can also experience a variety of symptoms associated with their disease a sedentary lifestyle and physical inactivity such as lower back and leg pain obstipation reduced sleep quality and impacted quality of life
Training can help alleviate these symptoms in patients with neuromuscular diseases However there isnt any validated way for patients with SMA to train as of today
Research has shown that high-intensity interval training HIIT has been well tolerated among patients with SBMA a disease resembling SMA with patients tolerating this form for training well
The aim of this study is to investigate1 if HIIT could be exercise modality in SMA patients 2 and to see what positive effects exercise has for their impaired motor function and related challenges
The investigators will test the participants at baseline which will be followed by a 8-week control period After the control period the participants will be tested again before the intervention period
During the intervention period the participants will have to train 5 times a week for 10 minutes After the intervention period there will be a final test day where the final results will be compared with those from the baseline
Besides the impaired motor function patients with SMA can also experience a variety of symptoms associated with their disease a sedentary lifestyle and physical inactivity such as lower back and leg pain obstipation reduced sleep quality and impacted quality of life
Training can help alleviate these symptoms in patients with neuromuscular diseases However there isnt any validated way for patients with SMA to train as of today
Research has shown that high-intensity interval training HIIT has been well tolerated among patients with SBMA a disease resembling SMA with patients tolerating this form for training well
The aim of this study is to investigate1 if HIIT could be exercise modality in SMA patients 2 and to see what positive effects exercise has for their impaired motor function and related challenges
The investigators will test the participants at baseline which will be followed by a 8-week control period After the control period the participants will be tested again before the intervention period
During the intervention period the participants will have to train 5 times a week for 10 minutes After the intervention period there will be a final test day where the final results will be compared with those from the baseline
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