Clinical trial NCT06368076: High-intensity Interval Training in Patients With Spinal Muscular Atrophy
Official title: High-intensity Interval Training in Patients With Spinal Muscular Atrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Muscular Atrophy
Keywords: Wheelchair cycle exercise
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 isn´t 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 investigate:(1) 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.

Eligibility criteria: Inclusion Criteria:

* Spinal muscular atrophy
* Age: over 15 years

Exclusion Criteria:

* Competing disorders (as arthritis) or other muscle disorders as well as heart- or lung related issues.
* Current psychiatric treatment
* Unable to use the cycle ergometer due to contractures

Primary outcomes:
measure: Questionnaire on fatigue
timeFrame: 5 minutes
measure: Questionnaire on pain.
timeFrame: 5 minutes
measure: Questionnaire on constipation
timeFrame: 5 minutes
measure: Questionnaire on quality of life
timeFrame: 10 minutes
measure: Questionnaire on sleep quality
timeFrame: 10 minutes
Secondary outcomes:
measure: Blood sample
timeFrame: 2 minutes
measure: Blood sample
timeFrame: 2 minutes
measure: Blood sample
timeFrame: 2 minutes
measure: Blood sample
timeFrame: 2 minutes
measure: Blood sample
timeFrame: 2 minutes
measure: Blood sample
timeFrame: 2 minutes
measure: Blood sample
timeFrame: 2 minutes
measure: Blood sample
timeFrame: 2 minutes
measure: Blood sample
timeFrame: 2 minutes
measure: Blood sample
timeFrame: 2 minutes
measure: MRI scan liver size
timeFrame: 5 minutes
measure: MR-elastography
timeFrame: 5 minutes
measure: MRI scan liver steatosis
timeFrame: 5 minutes
measure: Ultrasound scan
timeFrame: 15 minutes
measure: MRI scan
timeFrame: 15 minutes
measure: MRI scan
timeFrame: 15 minutes
measure: Exercise test
timeFrame: 7 minutes
measure: Motorscore
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: John Vissing, prof. MD
role: PRINCIPAL_INVESTIGATOR
References: