Back to resultsRespiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers
Primary Purpose
Manual Therapies, Respiratory Muscle Training, Exercise Therapy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory Muscle training
IMT + Manual Therapy and Motor Control Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Manual Therapies focused on measuring Smokers, Maximum Inspiratory Pressure
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).
Sites / Locations
- Centro Superior de Estudios Universitarios La Salle
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Inspiratory Muscle Training Group (IMT)
IMT + Manual Therapy and Motor Control Exercises
Arm Description
The IMT program consisted of supervised and domiciliary exercises. - 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 - 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
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: - 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 - 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
Full Information
NCT ID
NCT02514161
First Posted
July 29, 2015
Last Updated
November 30, 2015
Sponsor
Universidad Autonoma de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02514161
Brief Title
Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers
Official Title
Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Moderate Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Manual Therapies, Respiratory Muscle Training, Exercise Therapy, Inspiratory Capacity
Keywords
Smokers, Maximum Inspiratory Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory Muscle Training Group (IMT)
Arm Type
Active Comparator
Arm Description
The IMT program consisted of supervised and domiciliary exercises.
- 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
- 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
Arm Title
IMT + Manual Therapy and Motor Control Exercises
Arm Type
Experimental
Arm Description
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:
- 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
- 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.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle training
Intervention Description
This protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama)
Intervention Type
Other
Intervention Name(s)
IMT + Manual Therapy and Motor Control Exercise
Intervention Description
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 Measure Information:
Title
Maximum Inspiratory Pressure
Description
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.
Time Frame
Change from Baseline in Maximum Inspiratory Pressure at 4 weeks
Secondary Outcome Measure Information:
Title
Head posture
Description
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.
Time Frame
Change from Baseline in Head Posture at 4 weeks
Title
Thoracic kyphosis
Description
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.
Time Frame
Change from Baseline in Thoracic kyphosis at 4 weeks
Title
Volumes and lung capacities
Description
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
Time Frame
Change from Baseline in Volumes and lung capacities at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Centro Superior de Estudios Universitarios La Salle
City
Madrid
ZIP/Postal Code
28023
Country
Spain
12. IPD Sharing Statement
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Respiratory Exercises Versus Manual Therapy and Respiratory Exercises in Moderate Smokers
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