High-intensity Interval Training in Patients With Spinal Muscular Atrophy
- Conditions
- Spinal Muscular Atrophy
- Interventions
- Behavioral: Exercise
- Registration Number
- NCT06368076
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Spinal muscular atrophy
- Age: over 15 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exercise Exercise -
- Primary Outcome Measures
Name Time Method Questionnaire on quality of life 10 minutes A QoL that has been used in former studies will be used. 16 questions with scores ranging from 1 (very unsatisfied) to 7 (very satisfied) will be scored.
Questionnaire on constipation 5 minutes A questionnaire made from the Danish definition of constipation will be used. Four questions will be answered "yes" or "no".
Questionnaire on pain. 5 minutes A visual pain score for leg and lower back pain with 3 questions with scores ranging from 1 to 10 each, 10 being the worst pain imaginable, will be used.
Questionnaire on fatigue 5 minutes The Multidimensional Fatigue Inventory (MFI-20) will be used. It measures fatigue in 5 different domains comprised of 4 items each with values ranging from 1 to 5. A higher score indicates more fatigue. Each domain is scored individually, ranging from 4 points (best outcome) to 20 points (worst outcome).
Questionnaire on sleep quality 10 minutes Minimum Score = 0 (better); Maximum Score = 21 (worse) Interpretation: TOTAL \< 5 associated with good sleep quality TOTAL \> 5 associated with poor sleep quality Minimum Score = 0 (better); Maximum Score = 21 (worse) Interpretation: TOTAL \< 5 associated with good sleep quality TOTAL \> 5 associated with poor sleep quality Minimum score is 0, maximum score is 21. Total over 5 is associated with good sleep quality and under 5 associated with poor sleep quality.
- Secondary Outcome Measures
Name Time Method Ultrasound scan 15 minutes Additional assessment of liver size, fibrosis and steatosis
Motorscore 20 minutes Change in motor function score, using the Motor Function Measurement (MFM-32). Assesses motor function in 3 domains, 32 two items in total. A higher score in each domain indicates better function.
MRI scan liver size 5 minutes Assessment of liver size
Exercise test 7 minutes Change in time to cycle X km in minutes
MR-elastography 5 minutes Assessment of liver fibrosis (assessed by MR-elastography)
Blood sample 2 minutes Change in blood sample for bilirubin (liver parameter) in umol/L
MRI scan liver steatosis 5 minutes Assessment of liver steatosis
MRI scan 15 minutes Assessment of muscle degeneration and subsequent fat replacement (using Dixon method to visualise fat in an optimal way)
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark