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Completed

NCT Number: NCT02690831

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

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.

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Key information

Conditions

Manual Therapies Asthma Bronchial Diseases Exercise Therapy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inspiratory Capacity Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Muscle Training Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Superior de Estudios Universitarios La Salle

Madrid, 28023, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspiratory muscle training (IMT)

Other

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

Other

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

Powerbreathe

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 24, 2016
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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