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

NCT ID: NCT02690831

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-09-30

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.

Conditions

Manual Therapies; Respiratory Muscle Training; Exercise Therapy; Inspiratory Capacity; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Inspiratory Muscle training (IMT)

Intervention Type: OTHER

Inspiratory Muscle training This protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama)

Powerbreathe

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

IMT + Manual Therapy and Motor Control Exercise

Intervention Type: 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

Intervention Type: DEVICE

Interventions

Inspiratory Muscle training (IMT)

Inspiratory Muscle training This protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama)

Intervention Type: 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

Intervention Type: OTHER

Powerbreathe

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Pablo Candelas Fernández

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Superior de Estudios Universitarios La Salle

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

Universidad Autonoma de Madrid

Identifier Type: -

Identifier Source: org_study_id