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Spinal Muscular AtrophyNCT06368076

High-intensity Interval Training in Patients With Spinal Muscular Atrophy

A study testing Exercise in people with Spinal Muscular Atrophy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Spinal Muscular Atrophy
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
9 Jan 2024to Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Spinal muscular atrophy
  • Age: over 15 years

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Sophia Frølich, stud.med, + 45 3545 3561, sophia.vera.froelich.01@regionh.dk

    Noémie Receveur, stud.med, +4535453561, noemie.anne-marie.receveur.03@regionh.dk

    Recruiting

Other trials in Denmark

About this study

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.

Read the 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.

Being tested
Exercise
Keywords
Wheelchair cycle exercise
Medical subject headings
Muscular Atrophy, Spinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    High intensity interval training on a bike or pedaltrainer from the wheelchair.

Study groups in NCT06368076
Study groupRoleWhat they receive
ExerciseExperimentalNot described
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 5 minutes

  2. 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.

    Measured: 5 minutes

  3. Questionnaire on constipation

    A questionnaire made from the Danish definition of constipation will be used. Four questions will be answered "yes" or "no".

    Measured: 5 minutes

  4. 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.

    Measured: 10 minutes

  5. 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.

    Measured: 10 minutes

Secondary outcomes (18)

  1. Blood sample

    Change in blood sample for blood lipids, mmol/l

    Measured: 2 minutes

  2. Blood sample

    Change in blood sample for HbA1C, mmol/mol

    Measured: 2 minutes

  3. 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.

    Measured: 2 minutes

  4. Blood sample

    Change in blood sample for fasting blood glucose, in mmol/L

    Measured: 2 minutes

  5. Blood sample

    Change in blood sample for fasting insulin, in pmol/L.

    Measured: 2 minutes

  6. Blood sample

    Change in blood sample for fasting c-peptide, in pmol/L.

    Measured: 2 minutes

  7. Blood sample

    Change in blood sample for ALT (liver parameter) in U/L

    Measured: 2 minutes

  8. Blood sample

    Change in blood sample for AST (liver parameter) in U/L

    Measured: 2 minutes

  9. Blood sample

    Change in blood sample for alkaline phosphatase (liver parameter) in U/L

    Measured: 2 minutes

  10. Blood sample

    Change in blood sample for bilirubin (liver parameter) in umol/L

    Measured: 2 minutes

  11. MRI scan liver size

    Assessment of liver size

    Measured: 5 minutes

  12. MR-elastography

    Assessment of liver fibrosis (assessed by MR-elastography)

    Measured: 5 minutes

  13. MRI scan liver steatosis

    Assessment of liver steatosis

    Measured: 5 minutes

  14. Ultrasound scan

    Additional assessment of liver size, fibrosis and steatosis

    Measured: 15 minutes

  15. MRI scan

    Assessment of full body muscle size

    Measured: 15 minutes

  16. MRI scan

    Assessment of muscle degeneration and subsequent fat replacement (using Dixon method to visualise fat in an optimal way)

    Measured: 15 minutes

  17. Exercise test

    Change in time to cycle X km in minutes

    Measured: 7 minutes

  18. 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.

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start9 Jan 2024
  3. Primary completionAug 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06368076
Sponsor's protocol ID
H-23065096
Status last verified
Apr 2024
First submitted
29 Feb 2024
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Spinal Muscular Atrophy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sophia Frølich, stud.med (+ 45 3545 3561, sophia.vera.froelich.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questionnaire on fatigue (time frame: 5 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06368076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.

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