Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers

NCT02514161 | Completed DMC

• 1 other identifier: CSEU La Salle
• Study Type: interventional
• Target: 53
• 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 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

Keywords

Smokers; Maximum Inspiratory Pressure

Outcome Measures

Primary Outcomes (1)

• Maximum Inspiratory Pressure

  The maximum inspiratory pressure (MIP) was measured with a device called Kinetic KH1 Powerbreath (HAB International Ltd., England, UK). 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 4 weeks

Secondary Outcomes (3)

• Head posture

  Change from Baseline in Head Posture at 4 weeks

• Thoracic kyphosis

  Change from Baseline in Thoracic kyphosis at 4 weeks

• Volumes and lung capacities

  Change from Baseline in Volumes and lung capacities at 4 weeks

Study Arms (2)

Inspiratory Muscle Training Group (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 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

Other: Inspiratory Muscle training

IMT + Manual Therapy and Motor Control Exercises

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 * 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.

Other: IMT + Manual Therapy and Motor Control Exercise

Interventions

Inspiratory Muscle training OTHER

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

Inspiratory Muscle Training Group (IMT)

IMT + Manual Therapy and Motor Control Exercise 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

IMT + Manual Therapy and Motor Control Exercises

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Study Sites (1)

Centro Superior de Estudios Universitarios La Salle

Madrid, Madrid, 28023, Spain

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations

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: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 3, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-07

Locations

ES (1)