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

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ClinicalTrials.gov Identifier: NCT02690831
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Pablo Candelas Fernández, 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.

Condition or disease Intervention/treatment Phase
Manual Therapies Respiratory Muscle Training Exercise Therapy Inspiratory Capacity Asthma Other: Inspiratory Muscle training (IMT) Other: IMT + Manual Therapy and Motor Control Exercise Device: Powerbreathe Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma
Study Start Date : December 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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.
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

Device: Powerbreathe



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690831


Locations
Spain
Centro Superior de Estudios Universitarios La Salle
Madrid, Spain, 28023
Sponsors and Collaborators
Universidad Autonoma de Madrid

Responsible Party: Pablo Candelas Fernández, Physiotherapist, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT02690831     History of Changes
Other Study ID Numbers: Universidad Autonoma de Madrid
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by Pablo Candelas Fernández, Universidad Autonoma de Madrid:
Asthma
Inspiratory Muscle Training
Manual Therapies

Additional relevant MeSH terms:
Asthma
Respiratory Aspiration
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Pathologic Processes