Effectiveness of Respiratory Physiotherapy in Children With Neuromuscular Disease

• Sponsor: University of Seville (Other)
• Overall Status: Completed
• CT.gov ID: NCT02743702
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Diseases	Other: RESPIRATORY PHYSIOTHERAPY; Other: USUAL THERAPIES	N/A

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.

The sample consisted of children diagnosed with NMD. For the evolution of different variables spirometric test was used for variables related to the function respiratory, and a tracking sheet designed by the researchers to collect the number hospital emergency visits each year, as well as hospital admissions, respiratory infections and need of antibiotics. These assessments were made before and after the start of program and during every four months.

Patients were randomized to control or experimental group, no apply any Respiratory Physical Therapy treatment in subjects in the first group and performing a Respiratory Physical Therapy program in the second. This program was carried out once in week by the physiotherapist, and four times weekly at home, by family, during one year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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.
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30 and 45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.	Other: RESPIRATORY PHYSIOTHERAPY; The protocol designed was composed of the following exercises: supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mouth slightly open. 3 replications in a sitting position, with help of an ambu bag, we made inflations. Repeated 3 times exercises of upper member coupled to respiratory rhythm: shoulder flexion and extension was carried out during the inspiratory phase and the extension and adduction of them during expiration. 3 times; Other: USUAL THERAPIES
Experimental: GROUP RECEIVING THEIR USUAL THERAPIES This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.	Other: USUAL THERAPIES

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Vital Capacity at One Year. [At baseline and at 1 year]

   Change from Baseline vital capacity at one year evaluated by spirometer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Being diagnosed with a Disease of the Neuromuscular junction, according to International Classification of Diseases 10.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla	Sevilla		Spain	41009

Sponsors and Collaborators

• University of Seville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ambrosino N, Vitacca M, Rampulla C. Standards for rehabilitative strategies in respiratory diseases. Monaldi Arch Chest Dis. 1995 Aug;50(4):293-318.
• Bach JR, Ishikawa Y, Kim H. Prevention of pulmonary morbidity for patients with Duchenne muscular dystrophy. Chest. 1997 Oct;112(4):1024-8.
• Chatwin M, Ross E, Hart N, Nickol AH, Polkey MI, Simonds AK. Cough augmentation with mechanical insufflation/exsufflation in patients with neuromuscular weakness. Eur Respir J. 2003 Mar;21(3):502-8.
• Danov Z, Schroth MK. Respiratory management of pediatric patients with neuromuscular disease. Pediatr Ann. 2010 Dec;39(12):769-76. doi: 10.3928/00904481-20101116-07. Review.
• Vianello A, Corrado A, Arcaro G, Gallan F, Ori C, Minuzzo M, Bevilacqua M. Mechanical insufflation-exsufflation improves outcomes for neuromuscular disease patients with respiratory tract infections. Am J Phys Med Rehabil. 2005 Feb;84(2):83-8; discussion 89-91.
• Watzek I, Winterholler M. [Basic principles of non-respiratory physiotherapy for neuromuscular diseases]. Pneumologie. 2008 Mar;62 Suppl 1:S28-30. doi: 10.1055/s-2007-1016426. Review. German.

• Responsible Party: JJ JIMENEZ-REJANO, PhD, University of Seville
• ClinicalTrials.gov Identifier: NCT02743702
• Other Study ID Numbers: USeville-JJIMENEZ-REJANO
• First Posted: Apr 19, 2016
• Last Update Posted: Jul 11, 2016
• Last Verified: May 1, 2016

• Keywords provided by JJ JIMENEZ-REJANO, PhD, University of Seville: Effectiveness; Physical therapy modalities; neuromuscular diseases
• Additional relevant MeSH terms: Neuromuscular Diseases

Study Results

Participant Flow

Arm/Group Title	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY	GROUP RECEIVING THEIR USUAL THERAPIES
Arm/Group Description	Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them. RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises: supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his	This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES
Period Title: Overall Study
STARTED	11	10
COMPLETED	11	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY	GROUP RECEIVING THEIR USUAL THERAPIES	Total
Arm/Group Description	Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them. RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises: supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his	This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES	Total of all reporting groups
Overall Participants	11	10	21
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	6	7.5	7
Sex: Female, Male (Count of Participants)
Female	3 27.3%	3 30%	6 28.6%
Male	8 72.7%	7 70%	15 71.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Vital Capacity at One Year.
Description	Change from Baseline vital capacity at one year evaluated by spirometer.
Time Frame	At baseline and at 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY	GROUP RECEIVING THEIR USUAL THERAPIES
Arm/Group Description	Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. Sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them. RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises: supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou	This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES
Measure Participants	11	10
Median (Inter-Quartile Range) [percentage of Change of vital capacity]	33.33	-7.41

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY, GROUP RECEIVING THEIR USUAL THERAPIES
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	1 year
Arm/Group Title	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY		GROUP RECEIVING THEIR USUAL THERAPIES
Arm/Group Description	Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for 1 year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them. RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises: supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou		This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES
All Cause Mortality
	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY		GROUP RECEIVING THEIR USUAL THERAPIES
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY		GROUP RECEIVING THEIR USUAL THERAPIES
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY		GROUP RECEIVING THEIR USUAL THERAPIES
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.