Trial Outcomes & Findings for Effectiveness of Respiratory Physiotherapy in Children With Neuromuscular Disease (NCT NCT02743702)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

At baseline and at 1 year

Results posted on

2016-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	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: * 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	GROUP RECEIVING THEIR USUAL THERAPIES This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES
Overall Study STARTED	11	10
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Respiratory Physiotherapy in Children With Neuromuscular Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY n=11 Participants 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	GROUP RECEIVING THEIR USUAL THERAPIES n=10 Participants This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES	Total n=21 Participants Total of all reporting groups
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	6 years n=5 Participants	7.5 years n=7 Participants	7 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline and at 1 year

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

Outcome measures

Outcome measures
Measure	GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY n=11 Participants 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	GROUP RECEIVING THEIR USUAL THERAPIES n=10 Participants This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies. USUAL THERAPIES
Change From Baseline Vital Capacity at One Year.	33.33 percentage of Change of vital capacity Interval 11.11 to 89.74	-7.41 percentage of Change of vital capacity Interval -15.6 to -3.82

Adverse Events

GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GROUP RECEIVING THEIR USUAL THERAPIES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jose J. Jimenez-Rejano

University of Seville

Phone: +34667309369

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place