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Muscle Energy Techniques in COPD Patients

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ClinicalTrials.gov Identifier: NCT04773860
Recruitment Status : Not yet recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Kimberley Sevasta, University of Malta

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Muscle Energy Techniques Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients diagnosed with COPD
Masking: Single (Participant)
Masking Description: Patients shall be randomly assigned to the intervention and control group.
Primary Purpose: Treatment
Official Title: Muscle Energy Techniques in Chronic Obstructive Disease Patients: Effects on Pulmonary Function and Activities of Daily Living
Estimated Study Start Date : February 23, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
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
 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
No Intervention: Control group
The control group will be taking their prescribed medication and continue with any conventional physiotherapy recommended for the individual.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Lung function test [ Time Frame: Week 0, Week 4 and Week 8 ]
    Spirometry

  2. Change in Chest expansion [ Time Frame: Week 0, Week 4 and Week 8 ]
    Chest expansion using a tape measure

  3. Change in 6 Minute Walk Test [ Time Frame: Week 0, Week 4 and Week 8 ]
    An endurance test over a 6 minute time frame using a 30m course

  4. Change in Manchester Related Activities of Daily Living Questionnaire [ Time Frame: Week 0, Week 4 and Week 8 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04773860


Contacts
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Contact: Kimberley Sevasta, BSc 79980164 ext 356 sevastakimberley@gmail.com
Contact: Anabel Sciriha, PhD 99423327 ext 356 anabel.sciriha@um.edu.mt

Sponsors and Collaborators
University of Malta
More Information
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Responsible Party: Kimberley Sevasta, Principal Investigator, University of Malta
ClinicalTrials.gov Identifier: NCT04773860    
Other Study ID Numbers: 333797
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kimberley Sevasta, University of Malta:
COPD
METs
Muscle Energy Techniques
Dyspnoea
Activities of daily living
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases