Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers

NCT ID: NCT02514161

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-11-30

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 moderate smokers. 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

Study Design

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

Study Groups

Inspiratory Muscle Training Group (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 4 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: 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

Intervention Type: OTHER

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

IMT + Manual Therapy and Motor Control Exercises

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
• Thoracic vertebral posteroanterior mobilization
• Thrust dorsal

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

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

Interventions

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

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

Eligibility Criteria

Inclusion Criteria

• Healthy subjects aged between 18 and 60 years and a current smoking rate ≥ 5 points.

Exclusion Criteria

• Were excluded participants who presented diagnosis of cardiorespiratory disease, systemic or metabolic disease such as rheumatoid arthritis or cancer, history of thoracic surgery, vertebral fracture, spinal structured musculoskeletal disorders and thoracic region and contraindication to the treatment techniques used (osteoporosis).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Autonoma de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Ibai López-de-Uralde-Villanueva

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Superior de Estudios Universitarios La Salle

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

CSEU La Salle

Identifier Type: -

Identifier Source: org_study_id