NCT04773860

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

February 23, 2021

Last Update Submit

February 25, 2021

Conditions

Keywords

COPDMETsMuscle Energy TechniquesDyspnoeaActivities of daily living

Outcome Measures

Primary Outcomes (4)

  • Change in Lung function test

    Spirometry

    Week 0, Week 4 and Week 8

  • Change in Chest expansion

    Chest expansion using a tape measure

    Week 0, Week 4 and Week 8

  • 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

  • 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

Study Arms (2)

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

Control group

NO INTERVENTION

The control group will be taking their prescribed medication and continue with any conventional physiotherapy recommended for the individual.

Interventions

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

Experimental

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Rheumatoid arthritis,
  • Musculoskeletal or neuromuscular pathology and,
  • Cognitive disability that could affect comprehension or execution of the intervention protocol or outcome measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Central Study Contacts

Kimberley Sevasta, BSc

CONTACT

Anabel Sciriha, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients shall be randomly assigned to the intervention and control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients diagnosed with COPD
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 26, 2021

Study Start

February 23, 2021

Primary Completion

September 30, 2022

Study Completion

June 30, 2023

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share