Chronic Obstructive Pulmonary DiseaseNCT04773860
Muscle Energy Techniques in COPD Patients
A study testing Muscle Energy Techniques in people with Chronic Obstructive Pulmonary Disease, run by University of Malta.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Muscle Energy Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Rheumatoid arthritis,
- Musculoskeletal or neuromuscular pathology and,
- Cognitive disability that could affect comprehension or execution of the intervention protocol or outcome measurements
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Muscle Energy Techniques in Chronic Obstructive Disease Patients: Effects on Pulmonary Function and Activities of Daily Living
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Muscle Energy Techniques
- Keywords
- COPD, METs, Muscle Energy Techniques, Dyspnoea, Activities of daily living
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy TechniquesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lung function test
Spirometry
Measured: Week 0, Week 4 and Week 8
Change in Chest expansion
Chest expansion using a tape measure
Measured: 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
Measured: 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
Measured: Week 0, Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start23 Feb 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients diagnosed with COPD
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberley Sevasta, University of Malta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773860
- Sponsor's protocol ID
- 333797
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Energy Techniques in Chronic Obstructive Disease Patients: Effects on Pulmonary Function and Activities of Daily Living
- ClinicalTrials.gov ID
- NCT04773860
- Acronym / sponsor ID
- 333797
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, METs, Muscle Energy Techniques, Dyspnoea, Activities of daily living
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Study start
- 23 Feb 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients diagnosed with COPD
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Muscle Energy TechniquesThe 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 |
| Control group | No intervention | –The control group will be taking their prescribed medication and continue with any conventional physiotherapy recommended for the individual. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Rheumatoid arthritis,
- Musculoskeletal or neuromuscular pathology and,
- Cognitive disability that could affect comprehension or execution of the intervention protocol or outcome measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Energy TechniquesA 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 | Other | Experimental |
Primary outcome
Change in Lung function test
Time frame: Week 0, Week 4 and Week 8
Spirometry
Change in Chest expansion
Time frame: Week 0, Week 4 and Week 8
Chest expansion using a tape measure
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Techniques in people with Chronic Obstructive Pulmonary Disease, run by University of Malta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberley Sevasta, BSc (79980164 ext. 356, sevastakimberley@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lung function test (time frame: Week 0, Week 4 and Week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021; AzTrials last refreshed its copy on 2 Nov 2026.