Neuromuscular DiseasesNCT02743702
Effectiveness of Respiratory Physiotherapy in Children With Neuromuscular Disease
A study testing RESPIRATORY PHYSIOTHERAPY and USUAL THERAPIES in people with Neuromuscular Diseases, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- RESPIRATORY PHYSIOTHERAPY and USUAL THERAPIES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being diagnosed with a Disease of the Neuromuscular junction, according to International Classification of Diseases 10.
- Be aged between 3 and 18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
Seville, Sevilla, 41009
About this study
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.
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.
Read the 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.
- Conditions
- Neuromuscular Diseases
- Being tested
- RESPIRATORY PHYSIOTHERAPY, USUAL THERAPIES
- Keywords
- Effectiveness, Physical therapy modalities, neuromuscular diseases
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPIRATORY PHYSIOTHERAPYOther
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
USUAL THERAPIESOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: RESPIRATORY PHYSIOTHERAPY; Other: USUAL THERAPIES |
| GROUP RECEIVING THEIR USUAL THERAPIES | Experimental | This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. Receives: Other: USUAL THERAPIES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Vital Capacity at One Year.
Change from Baseline vital capacity at one year evaluated by spirometer.
Measured: At baseline and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JJ JIMENEZ-REJANO, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743702
- Sponsor's protocol ID
- USeville-JJIMENEZ-REJANO
- Status last verified
- May 2016
- First submitted
- 5 Apr 2016
- Last updated
- 11 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 7550210Danov 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.
PubMed 21162485Bach 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.
PubMed 9377912Chatwin 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.
PubMed 12662009Vianello 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.
PubMed 15668554Watzek 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.
PubMed 18317980
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02743702
- Acronym / sponsor ID
- USeville-JJIMENEZ-REJANO
- Conditions
- Neuromuscular Diseases
- Keywords
- Effectiveness, Physical therapy modalities, neuromuscular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 11 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY | Experimental | Other: RESPIRATORY PHYSIOTHERAPY, Other: USUAL THERAPIESRespiratory 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 | Other: USUAL THERAPIESThis group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Being diagnosed with a Disease of the Neuromuscular junction, according to International Classification of Diseases 10.
- Be aged between 3 and 18 years.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESPIRATORY PHYSIOTHERAPYThe 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 | GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY |
| USUAL THERAPIES | Other | GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY, GROUP RECEIVING THEIR USUAL THERAPIES |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7550210Ambrosino 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.
- Background: PubMed 21162485Danov 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.
- Background: PubMed 9377912Bach 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.
- Background: PubMed 12662009Chatwin 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.
- Background: PubMed 15668554Vianello 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.
- Background: PubMed 18317980Watzek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESPIRATORY PHYSIOTHERAPY and USUAL THERAPIES in people with Neuromuscular Diseases, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Vital Capacity at One Year. (time frame: At baseline and at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743702, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.