Muscle Energy Techniques in COPD Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Muscle Energy Techniques
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, METs, Muscle Energy Techniques, Dyspnoea, Activities of daily living
Eligibility Criteria
Inclusion Criteria:
- The patient has to have been diagnosed as suffering from COPD by a medical consultant,
- Be medically stable with no exacerbations within the past 2 months and,
- Be between the age range of 40 to 79 years of age.
Exclusion Criteria:
- Rheumatoid arthritis,
- Musculoskeletal or neuromuscular pathology and,
- Cognitive disability that could affect comprehension or execution of the intervention protocol or outcome measurements
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control group
Arm Description
The experimental group shall be receiving a 4 week programme of Muscle Energy Techniques on the following accessory muscles; Sternocleidomastoid, Pectoralis Minor, Trapezius, Scalene muscles and Latissimus Dorsi
The control group will be taking their prescribed medication and continue with any conventional physiotherapy recommended for the individual.
Outcomes
Primary Outcome Measures
Change in Lung function test
Spirometry
Change in Chest expansion
Chest expansion using a tape measure
Change in 6 Minute Walk Test
An endurance test over a 6 minute time frame using a 30m course
Change in Manchester Related Activities of Daily Living Questionnaire
MR-ADL is a reliable physical disability scale. It is a self-completed scale and usually takes around 10 minutes to complete. It assesses functional ability in 4 different domains, that is in the kitchen, mobility, domestic tasks and leisure activities
Secondary Outcome Measures
Full Information
NCT ID
NCT04773860
First Posted
February 23, 2021
Last Updated
February 25, 2021
Sponsor
University of Malta
1. Study Identification
Unique Protocol Identification Number
NCT04773860
Brief Title
Muscle Energy Techniques in COPD Patients
Official Title
Muscle Energy Techniques in Chronic Obstructive Disease Patients: Effects on Pulmonary Function and Activities of Daily Living
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 23, 2021 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients diagnosed with COPD as a result of hyperinflation adapt to the increased workload through shortening and overactivation of other muscles because of their dual function as muscles of the upper limb and neck motion which makes them limited in function and decreases the range of motion in these joints. Another resultant effect of these changes is the shortness of breath taking place following the inability of patients to perform daily activities.
Current research is focusing on the use of Muscle Energy Techniques (METs) for such circumstances. Therefore, this study aims to evaluate whether METs result in an improvement in rib cage mobility which could potentially lead to improvements in pulmonary function and activities of daily of living (ADLs) in a group of patients diagnosed with COPD. If positive results are obtained, such an intervention might provide a possible addition to the evidence-based interventions already available for COPD patients. The result of this intervention may provide physiotherapists with further techniques for use in such patients; ones which will be of benefit to the patients and their quality of life and also to the health services.
Detailed Description
Patients diagnosed with COPD as a result of hyperinflation adapt to the increased workload through shortening and overactivation of other muscles because of their dual function as muscles of the upper limb and neck motion which makes them limited in function and decreases the range of motion in these joints. Another resultant effect of these changes is the shortness of breath taking place following the inability of patients to perform daily activities.
Current research is focusing on the use of Muscle Energy Techniques (METs) for such circumstances. Therefore, this study aims to evaluate whether METs result in an improvement in rib cage mobility which could potentially lead to improvements in pulmonary function and activities of daily of living (ADLs) in a group of patients diagnosed with COPD. If positive results are obtained, such an intervention might provide a possible addition to the evidence-based interventions already available for COPD patients. The result of this intervention may provide physiotherapists with further techniques for use in such patients; ones which will be of benefit to the patients and their quality of life and also to the health services.
A randomised controlled trial (RCT) shall be carried out on an approximate sample of 110 patients diagnosed with COPD. Participants shall be randomly assigned to an intervention and a control group. The intervention group shall be receiving a 4 week programme of Muscle Energy Techniques whereas the control group shall continue with their prescribed medications and any conventional physiotherapy sessions suggested for these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, METs, Muscle Energy Techniques, Dyspnoea, Activities of daily living
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients diagnosed with COPD
Masking
Participant
Masking Description
Patients shall be randomly assigned to the intervention and control group.
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group shall be receiving a 4 week programme of Muscle Energy Techniques on the following accessory muscles; Sternocleidomastoid, Pectoralis Minor, Trapezius, Scalene muscles and Latissimus Dorsi
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will be taking their prescribed medication and continue with any conventional physiotherapy recommended for the individual.
Intervention Type
Other
Intervention Name(s)
Muscle Energy Techniques
Intervention Description
A 4 week intervention will be carried out consisting of Muscle Energy Techniques on the accessory muscle of respiration. That is, Pectoralis Minor, Sternocleidomastoid, Upper trapezius, Scalene muscles and Latissimus Dorsi
Primary Outcome Measure Information:
Title
Change in Lung function test
Description
Spirometry
Time Frame
Week 0, Week 4 and Week 8
Title
Change in Chest expansion
Description
Chest expansion using a tape measure
Time Frame
Week 0, Week 4 and Week 8
Title
Change in 6 Minute Walk Test
Description
An endurance test over a 6 minute time frame using a 30m course
Time Frame
Week 0, Week 4 and Week 8
Title
Change in Manchester Related Activities of Daily Living Questionnaire
Description
MR-ADL is a reliable physical disability scale. It is a self-completed scale and usually takes around 10 minutes to complete. It assesses functional ability in 4 different domains, that is in the kitchen, mobility, domestic tasks and leisure activities
Time Frame
Week 0, Week 4 and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has to have been diagnosed as suffering from COPD by a medical consultant,
Be medically stable with no exacerbations within the past 2 months and,
Be between the age range of 40 to 79 years of age.
Exclusion Criteria:
Rheumatoid arthritis,
Musculoskeletal or neuromuscular pathology and,
Cognitive disability that could affect comprehension or execution of the intervention protocol or outcome measurements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberley Sevasta, BSc
Phone
79980164
Ext
356
Email
sevastakimberley@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anabel Sciriha, PhD
Phone
99423327
Ext
356
Email
anabel.sciriha@um.edu.mt
12. IPD Sharing Statement
Plan to Share IPD
No
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Muscle Energy Techniques in COPD Patients
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