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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690831
• Other study ID #: Universidad Autonoma de Madrid
• Status: Completed
• Phase: N/A
• First received: December 16, 2015
• Last updated: September 22, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Universidad Autonoma de Madrid
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Exercise Therapy
• Inspiratory Capacity
• Manual Therapies
• Respiratory Aspiration
• Respiratory Muscle Training

Intervention

Other:
• Inspiratory Muscle training (IMT)
Inspiratory Muscle training This protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama)
• IMT + Manual Therapy and Motor Control Exercise
IMT + Manual Therapy and Motor Control Exercise The Inspiratory Muscle Training protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama). Manual Therapy and Motor Control Exercises will consist of joint mobilization/manipulation and exercises in the neck and thoracic regions

Device:
• Powerbreathe

Locations

Country	Name	City	State
Spain	Centro Superior de Estudios Universitarios La Salle	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Inspiratory Pressure	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	Change from Baseline in Maximum Inspiratory Pressure at 6 weeks	No
Secondary	Head posture	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.	Change from Baseline in Head Posture at 6 weeks	No
Secondary	Thoracic kyphosis	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.	Change from Baseline in Thoracic kyphosis at 6 weeks	No
Secondary	Forced Vital Capacity (FVC)	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.	Change from Baseline in Volumes and lung capacities at 6 weeks	No
Secondary	Forced Expiratory Volume at the First second (FEV1)	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.	Change from Baseline in Volumes and lung capacities at 6 weeks	No
Secondary	Peak Expiratory Flow (PEF)	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.	Change from Baseline in Volumes and lung capacities at 6 weeks	No