Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers

Exercise Therapy Clinical Trial

Official title:

Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Moderate Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514161
• Other study ID #: CSEU La Salle
• Status: Completed
• Phase: N/A
• First received: July 29, 2015
• Last updated: November 30, 2015
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2015
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise Therapy
• Inspiratory Capacity
• Manual Therapies
• Respiratory Aspiration
• Respiratory Muscle Training

Intervention

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

Locations

Country	Name	City	State
Spain	Centro Superior de Estudios Universitarios La Salle	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Head posture	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.	Change from Baseline in Head Posture at 4 weeks	No
Secondary	Thoracic kyphosis	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.	Change from Baseline in Thoracic kyphosis at 4 weeks	No
Secondary	Volumes and lung capacities	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	Change from Baseline in Volumes and lung capacities at 4 weeks	No