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

September 22, 2016 updated by: Pablo Candelas Fernández, Universidad Autonoma de Madrid
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • Centro Superior de estudios Universitarios La SALLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Inspiratory Muscle training (IMT)

The IMT program consisted of supervised and domiciliary exercises:

  1. - The supervised exercises was performed in the presence of physiotherapist. This consisted of 30 min 2 days for 6 weeks using the threshold device (Powerbreathe classic level 1, Gaiam Ltd; Southam, Warwickshire, UK). This program involve 5 sets of 5 repetitions with 30 seconds rest between each one. The load of the training was distributed as follow:

    • First week: 30% Maximum Inspiratory Pressure (MIP)
    • Second week: 40% MIP
    • Third week: 50% MIP
    • Fourth week: 50% MIP
    • Fifth week: 60% MIP
    • Sixth week: 60% MIP
  2. - The domiciliary exercises consisted of Yoga Breathing Exercises (Pranayama) that combines the inspiration and expiration through one or both nostrils, and requires the activation of chest and abdomen.
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)
Device: Powerbreathe
Experimental: IMT + Manual Therapy and Motor Control Exercise

The protocol for this group is identical to the previous group with the sole difference that is added a manual therapy (MT) and a motor control exercises (MCE). The MT protocol was performed for 15min, whereas the MCE was 10min. Below it described both protocols:

  1. - MT:

    • Upper cervical region mobilization in flexion
    • Lower cervical postero-anterior mobilization + maintained traction
    • Costovertebral joint postero-anterior mobilization
    • Thrust dorsal
    • Cervical postero-anterior mobilization

  2. - MCE:

    • Isometric contraction of the deep neck flexors.
    • Isometric contraction of the neck extensors.
    • Neural self-mobilization.
    • Cervical retraction with theraband.
    • Sphinx.
    • Scapular adduction exercises in prone.
    • Scapular adduction exercises in sitting position with theraband.
Device: Powerbreathe
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Inspiratory Pressure
Time Frame: 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
Change from Baseline in Maximum Inspiratory Pressure at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head posture
Time Frame: 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.
Change from Baseline in Head Posture at 6 weeks
Thoracic kyphosis
Time Frame: 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.
Change from Baseline in Thoracic kyphosis at 6 weeks
Forced Vital Capacity (FVC)
Time Frame: 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.
Change from Baseline in Volumes and lung capacities at 6 weeks
Forced Expiratory Volume at the First second (FEV1)
Time Frame: 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.
Change from Baseline in Volumes and lung capacities at 6 weeks
Peak Expiratory Flow (PEF)
Time Frame: 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.
Change from Baseline in Volumes and lung capacities at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Universidad Autonoma de Madrid

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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