NCT02743702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

April 5, 2016

Results QC Date

April 21, 2016

Last Update Submit

May 30, 2016

Conditions

Neuromuscular Diseases

Keywords

EffectivenessPhysical therapy modalitiesneuromuscular diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Other: RESPIRATORY PHYSIOTHERAPYOther: USUAL THERAPIES

GROUP RECEIVING THEIR USUAL THERAPIES

EXPERIMENTAL

This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.

Other: USUAL THERAPIES

Interventions

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

GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY
USUAL THERAPIESOTHER
GROUP RECEIVING RESPIRATORY PHYSIOTHERAPYGROUP RECEIVING THEIR USUAL THERAPIES

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being diagnosed with a Disease of the Neuromuscular junction, according to International Classification of Diseases 10.
  • Be aged between 3 and 18 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla

Seville, Sevilla, 41009, Spain

Location

Related Publications (6)

  • 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.

    PMID: 7550210BACKGROUND

  • 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.

    PMID: 21162485BACKGROUND

  • 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.

    PMID: 9377912BACKGROUND

  • 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.

    PMID: 12662009BACKGROUND

  • 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.

    PMID: 15668554BACKGROUND

  • 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.

    PMID: 18317980BACKGROUND

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Results Point of Contact

Title
Dr. Jose J. Jimenez-Rejano
Organization
University of Seville
jjjimenez@us.es
+34667309369

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 19, 2016

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

July 11, 2016

Results First Posted

July 11, 2016

Record last verified: 2016-05

Locations

ES(1)