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Respiratory Muscle Training in Patients With Spinal Muscular Atrophy (SMA).

NCT05632666 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-30

No results posted yet for this study

Summary

The goal of this clinical trial is to study respiratory muscle training in patients with Spinal Muscular Atrophy (SMA). The main questions it aims to answer are:

* Is a home-based individualized training program for the inspiratory and expiratory muscles feasible (good adherence and good acceptability)?
* Can a home-based individualized training program for the inspiratory and expiratory muscles increase the strength of these muscles? Participants will be asked to perform 10 training sessions per week, spread out over 5-7 days. Each training session consists of 30 breathing cycles through the inspiratory muscle trainer and 30 breathing cycles trough the expiratory muscle trainer.

In the first four months of the study researchers will compare two groups to see if a higher trainings load is more effective.

One group will start at a trainings load of 10% of their maximal inspiratory and expiratory muscle strength.

The other group will start at a trainings load of 30% of their maximal inspiratory and expiratory muscle strength. This group also need to adjust the trainings load based on their perceived exertion.

After four months all participants will train on a trainings load of 30% of their maximal inspiratory and expiratory muscle strength and adjust the trainings load based on their perceived exertion.

The participants will come to the hospital for lung function tests every four months for 12 months.

Conditions

Interventions

OTHER

Inspiratory and expiratory muscle training at a therapeutic intensity

The active treatment group will receive inspiratory muscle training starting at a therapeutic intensity of 30% of maximum inspiratory mouth pressure (PImax) and expiratory muscle training starting at a therapeutic intensity of 30% of maximum expiratory mouth pressure (PEmax) for 4 months. In the active treatment group, the inspiratory and expiratory threshold (intensity) will be adjusted to the perceived exertion (measured with a Borg scale).

OTHER

Inspiratory and expiratory muscle training at a non-therapeutic intensity

The sham-control group will receive the same training protocol as the active treatment group but with a low (10% of PImax and PEmax) and stable non-therapeutic intensity.

Sponsors & Collaborators

  • Princess Beatrix Muscle Foundation

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Erik Hulzebos, Dr · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05632666 on ClinicalTrials.gov