Effectiveness of a Protocol of Respiratory Physiotherapy for Improvement or Maintenance of Respiratory Function, and Incidence of Respiratory Infections in Children With Neuromuscular Diseases, Compared With no Approach by Respiratory Physiotherapy of Respiratory Difficulties: A Randomized Clinical Trial With Two Groups in Parallel With Blinded Evaluator.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Seville
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Change From Baseline Vital Capacity at One Year.
Study Overview
Brief Summary
The main objective of this study is to determine whether the Respiratory Physiotherapy allows improvement or maintenance of respiratory function in children with Neuromuscular Diseases, against respiratory deterioration that occurs in the group of subjects who did not receive this treatment. And to determine whether decreasing the number of respiratory infections and secondly the need for antibiotics and the number of emergency room visits and hospital admissions related to these.
Detailed Description
Background:
Many authors have demonstrated the efficacy of Physiotherapy in Respiratory attending respiratory difficulties associated with different types of pathologies (Chronic Obstructive Pulmonary Disease, cystic fibrosis, tumors), however the investigators did not find studies with scientific evidence demonstrating the effectiveness of these programs in children with Neuromuscular Diseases (NMD), whose quality and life expectancy depends largely on the proper handling of Bronchial secretions and delay the deterioration of respiratory function.
The main objective of this study focuses on determining the effectiveness of physiotherapy for the treatment of respiratory breathing difficulties in children with NMD. Deducing other aspects such as the impact of this program on the number of visits to hospital emergencies department each year, hospital admissions and respiratory infections suffered by these children, and the need or not of antibiotics.
Material and method:
This research is an analytical, longitudinal, prospective, experimental, evaluator blinded study. It is controlled with two parallel groups, randomized clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Being diagnosed with a Disease of the Neuromuscular junction, according to International Classification of Diseases
- •Be aged between 3 and 18 years.
Exclusion Criteria
- •Being unable to perform spirometry, for physical or psychological difficulties.
- •Be involved in another program Respiratory Physiotherapy.
- •Present some kind of associated pathology (such as broken ribs, state epilepticus ...) in which it is contraindicated any maneuvers of the respiratory therapy protocol designed.
- •If researchers are informed of the existence of a serious illness of the father / mother / tutor that preclude to carrying out the program of respiratory Physiotherapy at home.
Outcomes
Primary Outcomes
Change From Baseline Vital Capacity at One Year.
Time Frame: At baseline and at 1 year
Change from Baseline vital capacity at one year evaluated by spirometer.
Secondary Outcomes
No secondary outcomes reported
Investigators
JJ JIMENEZ-REJANO
PhD
University of Seville