High-intensity Interval Training in Patients With Spinal Muscular Atrophy

NCT ID: NCT06368076

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-09

Study Completion Date

2025-01-31

Brief Summary

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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

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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.

Conditions

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Spinal Muscular Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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John Vissing

Prof. MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Vissing, prof. MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sophia Frølich, stud.med

Role: CONTACT

+ 45 3545 3561

Noémie Receveur, stud.med.

Role: CONTACT

+45 3545 3561

Facility Contacts

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Sophia Frølich, stud.med

Role: primary

+ 45 3545 3561

Noémie Receveur, stud.med

Role: backup

+4535453561

Other Identifiers

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H-23065096

Identifier Type: -

Identifier Source: org_study_id

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