ClinicalTrials.gov
ClinicalTrials.gov Menu

Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02514161
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Ibai López-de-Uralde-Villanueva, Universidad Autonoma de Madrid

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.

Condition or disease Intervention/treatment Phase
Manual Therapies Respiratory Muscle Training Exercise Therapy Inspiratory Capacity Other: Inspiratory Muscle training Other: IMT + Manual Therapy and Motor Control Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Moderate Smokers
Study Start Date : June 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Other: Inspiratory Muscle training
This protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama)

Experimental: 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.
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




Primary Outcome Measures :
  1. Maximum Inspiratory Pressure [ Time Frame: Change from Baseline in Maximum Inspiratory Pressure at 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Head posture [ Time Frame: Change from Baseline in Head Posture at 4 weeks ]
    The head posture was measured through the Cervical Range of Motion (CROM) device. 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 4 weeks ]
    The measurement of the thoracic kyphosis was performed through flexicurve. 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. Volumes and lung capacities [ Time Frame: Change from Baseline in Volumes and lung capacities at 4 weeks ]
    The investigators used a simple Spirometry. The Spirometry was performed according to American Thoracic Society criteria with a portable Spirometer model spirobank usb (MIR Rome, Italy). The measures assessed in this outcome were: Forced Vital Capacity (FVC), Forced Expiratory Volume at the First second (FEV1), and Peak Expiratory Flow (PEF). The maneuver was performed 3 times and recording the best one



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514161


Locations
Spain
Centro Superior de Estudios Universitarios La Salle
Madrid, Spain, 28023
Sponsors and Collaborators
Universidad Autonoma de Madrid

Responsible Party: Ibai López-de-Uralde-Villanueva, Principal Investigator, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT02514161     History of Changes
Other Study ID Numbers: CSEU La Salle
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: July 2015

Keywords provided by Ibai López-de-Uralde-Villanueva, Universidad Autonoma de Madrid:
Smokers
Maximum Inspiratory Pressure

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes