Back to resultsEffects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma
Primary Purpose
Manual Therapies, Respiratory Muscle Training, Exercise Therapy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inspiratory Muscle training (IMT)
IMT + Manual Therapy and Motor Control Exercise
Powerbreathe
Sponsored by
About this trial
This is an interventional treatment trial for Manual Therapies focused on measuring Asthma, Inspiratory Muscle Training, Manual Therapies
Eligibility Criteria
Inclusion Criteria:
- Asthmatics subjects aged between 18 and 65 years
Exclusion Criteria:
- Were excluded participants who presented neurologic, psychiatric or cognitive pathologies which difficult the cooperation, inflammatory disease of the cervical spine and/or severe orthopedic problems that difficult the daily activities, history of thoracic surgery, vertebral fracture, abnormal thorax radiography, spinal and thoracic structured musculoskeletal disorders and to present any contraindication of treatment techniques (e.g. ostheophorosis). In case of exacerbation of asthma, missing more than one treatment session and/or to appear any contraindication to continue the treatment routine during the six weeks of the study the patient also were excluded.
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 (IMT)
IMT + Manual Therapy and Motor Control Exercise
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 6 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: 50% MIP Fifth week: 60% MIP Sixth 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 Thrust dorsal Cervical postero-anterior mobilization - 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 in cmH2O. 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 in centimetres. 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 in degrees. 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.
Forced Vital Capacity (FVC)
The measurement of the Forced Vital Capacity was performed through a simple Spirometry.The Spirometry was performed according to American Thoracic Society criteria and was measured in litres. The maneuver was performed 3 times and recording the best one.
Forced Expiratory Volume at the First second (FEV1)
The measurement of the Forced Espiratory Volumen at first second was performed through a simple Spirometry.The Spirometry was performed according to American Thoracic Society criteria and was measured in litres. The maneuver was performed 3 times and recording the best one.
Peak Expiratory Flow (PEF)
The measurement of the Peak Expiratory Flow was performed through a simple Spirometry.The Spirometry was performed according to American Thoracic Society criteria and was measured in litres. The maneuver was performed 3 times and recording the best one.
Full Information
NCT ID
NCT02690831
First Posted
December 16, 2015
Last Updated
September 22, 2016
Sponsor
Universidad Autonoma de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02690831
Brief Title
Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma
Official Title
Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid
4. Oversight
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 patients with asthma. 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, Asthma
Keywords
Asthma, Inspiratory Muscle Training, Manual Therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory Muscle training (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 6 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: 50% MIP
Fifth week: 60% MIP
Sixth 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 Exercise
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
Thrust dorsal
Cervical postero-anterior mobilization
- 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 (IMT)
Intervention Description
Inspiratory Muscle training 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
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
Intervention Type
Device
Intervention Name(s)
Powerbreathe
Primary Outcome Measure Information:
Title
Maximum Inspiratory Pressure
Description
The maximum inspiratory pressure (MIP) was measured with a device called Kinetic KH1 Powerbreath in cmH2O. 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 6 weeks
Secondary Outcome Measure Information:
Title
Head posture
Description
The head posture was measured through the Cervical Range of Motion (CROM) device in centimetres. 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 6 weeks
Title
Thoracic kyphosis
Description
The measurement of the thoracic kyphosis was performed through flexicurve in degrees. 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 6 weeks
Title
Forced Vital Capacity (FVC)
Description
The measurement of the Forced Vital Capacity was performed through a simple Spirometry.The Spirometry was performed according to American Thoracic Society criteria and was measured in litres. The maneuver was performed 3 times and recording the best one.
Time Frame
Change from Baseline in Volumes and lung capacities at 6 weeks
Title
Forced Expiratory Volume at the First second (FEV1)
Description
The measurement of the Forced Espiratory Volumen at first second was performed through a simple Spirometry.The Spirometry was performed according to American Thoracic Society criteria and was measured in litres. The maneuver was performed 3 times and recording the best one.
Time Frame
Change from Baseline in Volumes and lung capacities at 6 weeks
Title
Peak Expiratory Flow (PEF)
Description
The measurement of the Peak Expiratory Flow was performed through a simple Spirometry.The Spirometry was performed according to American Thoracic Society criteria and was measured in litres. The maneuver was performed 3 times and recording the best one.
Time Frame
Change from Baseline in Volumes and lung capacities at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Asthmatics subjects aged between 18 and 65 years
Exclusion Criteria:
Were excluded participants who presented neurologic, psychiatric or cognitive pathologies which difficult the cooperation, inflammatory disease of the cervical spine and/or severe orthopedic problems that difficult the daily activities, history of thoracic surgery, vertebral fracture, abnormal thorax radiography, spinal and thoracic structured musculoskeletal disorders and to present any contraindication of treatment techniques (e.g. ostheophorosis). In case of exacerbation of asthma, missing more than one treatment session and/or to appear any contraindication to continue the treatment routine during the six weeks of the study the patient also were excluded.
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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Effects of Manual Therapy and Respiratory Muscle Training on the Maximal Inspiratory Pressure in Patients With Asthma
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