Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | High intensity interval training on a bike or pedaltrainer from the wheelchair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire on fatigue | 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). | 5 minutes |
| Questionnaire on pain. | 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. | 5 minutes |
| Questionnaire on constipation | A questionnaire made from the Danish definition of constipation will be used. Four questions will be answered "yes" or "no". | 5 minutes |
| Questionnaire on quality of life | 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. | 10 minutes |
| Questionnaire on 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 = 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. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood sample | Change in blood sample for blood lipids, mmol/l | 2 minutes |
| Blood sample | Change in blood sample for HbA1C, mmol/mol | 2 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophia Frølich, stud.med | Contact | + 45 3545 3561 | sophia.vera.froelich.01@regionh.dk | |
| Noémie Receveur, stud.med. | Contact | +45 3545 3561 | noemie.anne-marie.receveur.03@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| John Vissing, prof. MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood sample | Change in blood sample for Creatine kinase, U/I. This will be monitored before, in the middle and after the exercise period as a safety measure. | 2 minutes |
| Blood sample | Change in blood sample for fasting blood glucose, in mmol/L | 2 minutes |
| Blood sample | Change in blood sample for fasting insulin, in pmol/L. | 2 minutes |
| Blood sample | Change in blood sample for fasting c-peptide, in pmol/L. | 2 minutes |
| Blood sample | Change in blood sample for ALT (liver parameter) in U/L | 2 minutes |
| Blood sample | Change in blood sample for AST (liver parameter) in U/L | 2 minutes |
| Blood sample | Change in blood sample for alkaline phosphatase (liver parameter) in U/L | 2 minutes |
| Blood sample | Change in blood sample for bilirubin (liver parameter) in umol/L | 2 minutes |
| MRI scan liver size | Assessment of liver size | 5 minutes |
| MR-elastography | Assessment of liver fibrosis (assessed by MR-elastography) | 5 minutes |
| MRI scan liver steatosis | Assessment of liver steatosis | 5 minutes |
| Ultrasound scan | Additional assessment of liver size, fibrosis and steatosis | 15 minutes |
| MRI scan | Assessment of full body muscle size | 15 minutes |
| MRI scan | Assessment of muscle degeneration and subsequent fat replacement (using Dixon method to visualise fat in an optimal way) | 15 minutes |
| Exercise test | Change in time to cycle X km in minutes | 7 minutes |
| Motorscore | 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. | 20 minutes |
| D019636 | Neurodegenerative Diseases |
| D009468 | Neuromuscular Diseases |