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

NCT02690831 | Completed

• 1 other identifier: Universidad Autonoma de Madrid
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Asthma; Inspiratory Muscle Training; Manual Therapies

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Head posture

  Change from Baseline in Head Posture at 6 weeks

• Thoracic kyphosis

  Change from Baseline in Thoracic kyphosis at 6 weeks

• Forced Vital Capacity (FVC)

  Change from Baseline in Volumes and lung capacities at 6 weeks

• Forced Expiratory Volume at the First second (FEV1)

  Change from Baseline in Volumes and lung capacities at 6 weeks

• Peak Expiratory Flow (PEF)

  Change from Baseline in Volumes and lung capacities at 6 weeks

Study Arms (2)

Inspiratory Muscle training (IMT)

ACTIVE COMPARATOR

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); Device: Powerbreathe

IMT + Manual Therapy and Motor Control Exercise

EXPERIMENTAL

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; Device: Powerbreathe

Interventions

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)

Inspiratory Muscle training (IMT)

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

IMT + Manual Therapy and Motor Control Exercise

Powerbreathe DEVICE

IMT + Manual Therapy and Motor Control Exercise; Inspiratory Muscle training (IMT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asthmatics subjects aged between 18 and 65 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Study Sites (1)

Centro Superior de Estudios Universitarios La Salle

Madrid, Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Asthma

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: February 24, 2016
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

ES (1)