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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
University of Malta
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    February 23, 2021
    Last Updated
    February 25, 2021
    Sponsor
    University of Malta
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    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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