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Trial record 7 of 5217 for:    neuromuscular disease

Effectiveness of Respiratory Physiotherapy in Children With Neuromuscular Disease

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ClinicalTrials.gov Identifier: NCT02743702
Recruitment Status : Completed
First Posted : April 19, 2016
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
JJ JIMENEZ-REJANO, University of Seville

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuromuscular Diseases
Interventions Other: RESPIRATORY PHYSIOTHERAPY
Other: USUAL THERAPIES
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY GROUP RECEIVING THEIR USUAL THERAPIES
Hide 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
Arm/Group Title GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY GROUP RECEIVING THEIR USUAL THERAPIES Total
Hide 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 Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
6
(4 to 9)
7.5
(3.75 to 9.25)
7
(4 to 9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
3
  27.3%
3
  30.0%
6
  28.6%
Male
8
  72.7%
7
  70.0%
15
  71.4%
1.Primary Outcome
Title Change From Baseline Vital Capacity at One Year.
Hide Description Change from Baseline vital capacity at one year evaluated by spirometer.
Time Frame At baseline and at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY GROUP RECEIVING THEIR USUAL THERAPIES
Hide 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

Overall Number of Participants Analyzed 11 10
Median (Inter-Quartile Range)
Unit of Measure: percentage of Change of vital capacity
33.33
(11.11 to 89.74)
-7.41
(-15.60 to -3.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY, GROUP RECEIVING THEIR USUAL THERAPIES
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY GROUP RECEIVING THEIR USUAL THERAPIES
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY GROUP RECEIVING THEIR USUAL THERAPIES
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY GROUP RECEIVING THEIR USUAL THERAPIES
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jose J. Jimenez-Rejano
Organization: University of Seville
Phone: +34667309369
EMail: jjjimenez@us.es
Layout table for additonal information
Responsible Party: JJ JIMENEZ-REJANO, University of Seville
ClinicalTrials.gov Identifier: NCT02743702     History of Changes
Other Study ID Numbers: USeville-JJIMENEZ-REJANO
First Submitted: April 5, 2016
First Posted: April 19, 2016
Results First Submitted: April 21, 2016
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016