Manual Therapy in Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Soft tissue manual therapy protocol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of severe or very severe COPD (GOLD: Stage III or IV)
- Medically stable with no exacerbations in the preceding two months
Exclusion Criteria:
- A rheumatoid condition
- Neuromuscular or musculoskeletal pathology
- Cognitive disability that could influence their understanding or execution of the assessment tests or intervention protocol
- Supplemental oxygen dependency
- Previous or current enrollment in other pulmonary rehabilitation program
Sites / Locations
- Department of Physical Therapy, University of Chile
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Soft Tissue Manual Therapy Protocol
Arm Description
Soft tissue manual therapy protocol. Seven techniques of manual therapy in 30 minutes.
Outcomes
Primary Outcome Measures
Total Lung Capacity
Units in ml
Secondary Outcome Measures
Vital Capacity
Units in ml
Residual volume
units in ml
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02534831
Brief Title
Manual Therapy in Chronic Obstructive Pulmonary Disease
Official Title
The Effect of Soft Tissue Manual Therapy Intervention on Lung Function in Severe Chronic Obstructive Pulmonary Disease: a Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease characterized by progressive airflow limitation that is associated with an inflammatory response to noxious particles or gases.
Manual therapy (MT) has been defined as a therapeutic intervention that uses the hands to provide treatment to the musculoskeletal and/or visceral systems. It includes techniques such as massage, myofascial release, muscle energy technique, ligament balance, joint mobilization and joint manipulation. The suggestion that MT could deliver long-term benefits to people with COPD was first put forward in 2009. Since then a number of small studies have reported medium term improvements in lung function and exercise capacity following repeated applications of MT intervention.
Our aim is to measure the immediate effect on lung function of a single application of soft tissue manual therapy in patients with severe and very-severe chronic obstructive pulmonary disease.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease characterized by progressive airflow limitation that is associated with an inflammatory response to noxious particles or gases.
Changes in the anatomy of the airways and lung parenchyma occur as the result of bronchial hypersecretion and bronchoalveolar instability which cause expiratory flow limitation and air trapping. This is known clinically as dynamic hyperinflation. The phenomenon leads to an increase in expiratory reserve volume, residual volume and functional residual capacity, also referred to as end expiratory lung volume. These increases limit tidal volume and inspiratory reserve volume eventually affecting inspiratory capacity. They alter the position of the ribs causing a state similar to sustained inspiration over time, often referred to as 'inspiratory block'. This phenomenon is responsible for the characteristic 'barrel chest' commonly seen in patients with more advanced stages of COPD. In this state the position of the diaphragm is flattened and shortened reducing its ability to generate force. Accessory respiratory muscles are recruited as a compensatory adaptation leading to shortening and over-activation of these muscles over time (over-adaptation). The surrounding cervicothoracic fascia contracts producing postural changes such as anterior projection of the head, neck hyperextension, increased thoracic kyphosis and internal rotation of shoulders. These changes contribute to an increase in chest tightness, a decrease in the ability to generate inspiratory pressures and volumes and an increase in the amount of effort required to breath.
Manual therapy (MT) has been defined as a therapeutic intervention that uses the hands to provide treatment to the musculoskeletal and/or visceral systems. It includes techniques such as massage, myofascial release, muscle energy technique, ligament balance, joint mobilization and joint manipulation. The suggestion that MT could deliver long-term benefits to people with COPD was first put forward in 2009. Since then a number of small studies have reported medium term improvements in lung function and exercise capacity following repeated applications of MT intervention.
Our aim is to measure the immediate effect on lung function of a single application of soft tissue manual therapy in patients with severe and very-severe chronic obstructive pulmonary disease.
We recruitment patients with COPD in Rehabilitation Program in Hospital San José de Santiago de Chile, and we assessment: total lung capacity (TLC); vital capacity (VC); residual volume (RV); expiratory reserve volume (ERV); inspiratory capacity (IC); and airway resistance (Raw). Secondary: heart rate (HR); respiratory rate (RR); and oxygen saturation (SpO2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soft Tissue Manual Therapy Protocol
Arm Type
Experimental
Arm Description
Soft tissue manual therapy protocol. Seven techniques of manual therapy in 30 minutes.
Intervention Type
Procedure
Intervention Name(s)
Soft tissue manual therapy protocol
Intervention Description
The STMTP consisted of a pre-determined set of seven (7) soft tissue techniques delivered as part of a single treatment session lasting approximately 30 minutes. The techniques and their respective durations were: suboccipital release (5 minutes), anterior thoracic myofascial and sternum release (5 minutes), anterior cervical myofascial release (5 minutes), costal ligament balance (5 minutes) and muscular energy technique (MET) to the following muscles - scalenes (1 minute and 40 seconds), pectoralis minor (1 minute and 40 seconds) and latissimus dorsi and serratus anterior (1 minute and 40 seconds)
Primary Outcome Measure Information:
Title
Total Lung Capacity
Description
Units in ml
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Vital Capacity
Description
Units in ml
Time Frame
30 minutes
Title
Residual volume
Description
units in ml
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of severe or very severe COPD (GOLD: Stage III or IV)
Medically stable with no exacerbations in the preceding two months
Exclusion Criteria:
A rheumatoid condition
Neuromuscular or musculoskeletal pathology
Cognitive disability that could influence their understanding or execution of the assessment tests or intervention protocol
Supplemental oxygen dependency
Previous or current enrollment in other pulmonary rehabilitation program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Engel, PhD
Organizational Affiliation
Macquarie University, Australia
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physical Therapy, University of Chile
City
Santiago
State/Province
Metropolitan Región
ZIP/Postal Code
8380239
Country
Chile
12. IPD Sharing Statement
Learn more about this trial
Manual Therapy in Chronic Obstructive Pulmonary Disease
We'll reach out to this number within 24 hrs