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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04773860
Other study ID # 333797
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 23, 2021
Est. completion date June 30, 2023

Study information

Verified date February 2021
Source University of Malta
Contact Kimberley Sevasta, BSc
Phone 79980164
Email sevastakimberley@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date June 30, 2023
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: 1. The patient has to have been diagnosed as suffering from COPD by a medical consultant, 2. Be medically stable with no exacerbations within the past 2 months and, 3. Be between the age range of 40 to 79 years of age. Exclusion Criteria: 1. Rheumatoid arthritis, 2. Musculoskeletal or neuromuscular pathology and, 3. Cognitive disability that could affect comprehension or execution of the intervention protocol or outcome measurements

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Muscle Energy Techniques
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Malta

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Lung function test Spirometry Week 0, Week 4 and Week 8
Primary Change in Chest expansion Chest expansion using a tape measure Week 0, Week 4 and Week 8
Primary Change in 6 Minute Walk Test An endurance test over a 6 minute time frame using a 30m course Week 0, Week 4 and Week 8
Primary 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 Week 0, Week 4 and Week 8
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