- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02514161
Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers
Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Moderate Smokers
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28023
- Centro Superior de estudios Universitarios La SALLE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Inspiratory Muscle Training Group (IMT)
The IMT program consisted of supervised and domiciliary exercises.
|
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:
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from Baseline in Maximum Inspiratory Pressure at 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from Baseline in Head Posture at 4 weeks
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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.
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Change from Baseline in Thoracic kyphosis at 4 weeks
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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
|
Change from Baseline in Volumes and lung capacities at 4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSEU La Salle
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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