NCT05632666: RESISTANT

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

Status unknown NA Last updated 30 November 2022

What this trial tests

NA trial testing Inspiratory and expiratory muscle training at a therapeutic intensity in Spinal Muscular Atrophy in 30 participants. Status unknown.

Timeline

2 February 2021

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	UMC Utrecht
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	2 February 2021
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Inspiratory and expiratory muscle training at a therapeutic intensity
• Inspiratory and expiratory muscle training at a non-therapeutic intensity

Conditions studied

• Spinal Muscular Atrophy — all drugs for Spinal Muscular Atrophy →

Sponsor

UMC Utrecht — full company profile →

Who can join

8 and older, any sex, with Spinal Muscular Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The RESISTANT study (Respiratory Muscle Training in Patients with Spinal Muscular Atrophy): study protocol for a randomized controlled trial.
   Kant-Smits K, Bartels B, Asselman FL, Veldhoen ES, et al · · 2023 · cited 7× · PMID 36959618 · DOI 10.1186/s12883-023-03136-3