Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma

Not Applicable

Completed

• Conditions: Manual Therapies; Inspiratory Capacity; Exercise Therapy; Asthma; Respiratory Muscle Training

• Registration Number: NCT02690831
• Lead Sponsor: Universidad Autonoma de Madrid

Brief Summary

The aim of this study is to assess if an intervention of manual therapy and motor control exercises combined with an inspiratory muscle training program is more effective than an inspiratory muscle training program alone in increasing the maximum inspiratory pressure in patients with asthma. In addition, the study pretends to evaluate the changes caused by the intervention regarding possible postural changes and thoracic diameter.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-24
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Asthmatics subjects aged between 18 and 65 years

Exclusion Criteria

• Were excluded participants who presented neurologic, psychiatric or cognitive pathologies which difficult the cooperation, inflammatory disease of the cervical spine and/or severe orthopedic problems that difficult the daily activities, history of thoracic surgery, vertebral fracture, abnormal thorax radiography, spinal and thoracic structured musculoskeletal disorders and to present any contraindication of treatment techniques (e.g. ostheophorosis). In case of exacerbation of asthma, missing more than one treatment session and/or to appear any contraindication to continue the treatment routine during the six weeks of the study the patient also were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximum Inspiratory Pressure	Change from Baseline in Maximum Inspiratory Pressure at 6 weeks	The maximum inspiratory pressure (MIP) was measured with a device called Kinetic KH1 Powerbreath in cmH2O. This device applies an inspiratory load which provides a resistance. The maneuver was performed in a sitting position. Measuring a minimum of 3 times was performed, recording the highest value

Secondary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	Change from Baseline in Volumes and lung capacities at 6 weeks	The measurement of the Forced Vital Capacity was performed through a simple Spirometry.The Spirometry was performed according to American Thoracic Society criteria and was measured in litres. The maneuver was performed 3 times and recording the best one.
Forced Expiratory Volume at the First second (FEV1)	Change from Baseline in Volumes and lung capacities at 6 weeks	The measurement of the Forced Espiratory Volumen at first second was performed through a simple Spirometry.The Spirometry was performed according to American Thoracic Society criteria and was measured in litres. The maneuver was performed 3 times and recording the best one.
Peak Expiratory Flow (PEF)	Change from Baseline in Volumes and lung capacities at 6 weeks	The measurement of the Peak Expiratory Flow was performed through a simple Spirometry.The Spirometry was performed according to American Thoracic Society criteria and was measured in litres. The maneuver was performed 3 times and recording the best one.
Head posture	Change from Baseline in Head Posture at 6 weeks	The head posture was measured through the Cervical Range of Motion (CROM) device in centimetres. This instrument measures physiological movements of the cervical spine and head position. It´s a reliable method of measuring, providing a range of intra-meter reliability from 0.7 to 0.9 and a range of inter-meter reliability from 0.8 to 0.87. The evaluator instructed the patient to sit in a standardized position and assume a natural position of the head and the goniometer was placed over his head to measure the head posture.
Thoracic kyphosis	Change from Baseline in Thoracic kyphosis at 6 weeks	The measurement of the thoracic kyphosis was performed through flexicurve in degrees. It is a flexible rule that is molded to the back of the subject in order to replicate the shape of the spine. The flexicurve is a valid and reliable tool. The spinous processes of C7 and T12 were located, subsequently it placed on paper 10x10 to draw the curve and to obtained the index flexicurve.

Trial Locations

Locations (1)

Centro Superior de Estudios Universitarios La Salle; 🇪🇸 Madrid, Spain