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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY | Experimental | 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. |
|
| GROUP RECEIVING THEIR USUAL THERAPIES | Experimental | This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESPIRATORY PHYSIOTHERAPY | Other | The protocol designed was composed of the following exercises:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Vital Capacity at One Year. | Change from Baseline vital capacity at one year evaluated by spirometer. | At baseline and at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla | Seville | Sevilla | 41009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7550210 | Background | Ambrosino N, Vitacca M, Rampulla C. Standards for rehabilitative strategies in respiratory diseases. Monaldi Arch Chest Dis. 1995 Aug;50(4):293-318. No abstract available. | |
| 21162485 | Background | 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. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 30-45 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:
|
| FG001 | GROUP RECEIVING THEIR USUAL THERAPIES | This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 30-45 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Vital Capacity at One Year. | Change from Baseline vital capacity at one year evaluated by spirometer. | Posted | Median | Inter-Quartile Range | percentage of Change of vital capacity | At baseline and at 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jose J. Jimenez-Rejano | University of Seville | +34667309369 | jjjimenez@us.es |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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|
| USUAL THERAPIES | Other |
|
| 9377912 | Background | Bach JR, Ishikawa Y, Kim H. Prevention of pulmonary morbidity for patients with Duchenne muscular dystrophy. Chest. 1997 Oct;112(4):1024-8. doi: 10.1378/chest.112.4.1024. |
| 12662009 | Background | 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. doi: 10.1183/09031936.03.00048102. |
| 15668554 | Background | 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. doi: 10.1097/01.phm.0000151941.97266.96. |
| 18317980 | Background | 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. German. |
| BG001 | GROUP RECEIVING THEIR USUAL THERAPIES | This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | GROUP RECEIVING THEIR USUAL THERAPIES | This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | GROUP RECEIVING THEIR USUAL THERAPIES | This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES | 0 | 10 | 0 | 10 |
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