Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000801213
Ethics application status
Approved
Date submitted
15/03/2018
Date registered
11/05/2018
Date last updated
31/05/2021
Date data sharing statement initially provided
10/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Muscle Energy Technique for Chronic Obstructive Pulmonary Disease
Scientific title
Muscle Energy Technique for Chronic Obstructive Pulmonary Disease: A feasibility trial
Secondary ID [1] 294229 0
None
Universal Trial Number (UTN)
U1111-1210-2654
Trial acronym
MET for COPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 306894 0
Condition category
Condition code
Respiratory 305991 305991 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 306832 306832 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Muscle Energy Technique

Muscle Energy Technique is a gentle manual therapy technique used by manual therapists (osteopaths, physiotherapists, chiropractors, myotherapists) around the world. The goal of the technique is to lengthen hypertonic muscles and improve range of motion of joints in the body.

Essential elements of the manual technique involve the following steps:
- Practitioner puts the muscle to be treated on stretch
- Patient is instructed to contract the specific muscle in a specific direction for 3-5 seconds
- Practitioner resists the movement in a controlled fashion for 3-5 seconds
- Patient is instructed to stop contracting the muscle. In this period the practitioner further stretches the muscle slowly to a new resting length
- Repeat this muscle contraction 3-5 times.

The positions that the participant may be positioned in- supine, prone, sidelying, seated. The regions that will be treated include: neck, back (upper and lower), rib cage and associated muscles.

Materials provided to patients: Participants may be shown an A4 page of images depicting the types of positions that the participant may be asked to be in and the type of application of technique. The materials can be accessed from the researcher and intervention provider.

The intervention provider is a registered Osteopath with Australian Healthcare Practitioner Regulation Agency (AHPRA).

Mode of delivery- 'hands on' from the intervention provider. The intervention is provided to the individual participant for up to 15 minutes prior to the Pulmonary Rehabilitation session.

The location of the intervention sessions will be at he Austin Hospital in the physiotherapy department. The intervention will be applied in a private room next to the exercise room. In the room is a hospital bed that can be moved electronically.

The intervention is applied concurrently with Pulmonary Rehabilitation, over 8 weeks. The intervention is applied prior to the exercise session for up to 15 minutes (maximum) in week 1,2,3,5,6 and 7 (total of 6 intervention sessions over the 8 week program). There is no intervention applied in week 4 and 8. The frequency of the application of the intervention is once per week for up to 15 minutes. This is one-on-one with the person administering the intervention. The person administering the intervention is an AHPRA registered osteopath.

The intervention is semi-standardised. This means that each individual participant is assessed in the same regions (i.e neck left/ right, upper and lower back left/ right) and then the intervention is applied tailored to the individual findings. Individual findings will not change the type of intervention applied. It will only change the regions treated. For example, if the findings require the positioning of the upper extremity in a certain position, but the individual is unable to lift their arm to the required position, the intervention is able to be modified in terms of treating another region, or in another position. Individual findings also means that treatment (intervention) is applied to a finding, and regions are not treated unnecessarily.

The intervention has not currently been modified during the study. No intervention adherence or fidelity was assessed as there have been no modifications.

Strategies used to monitor participant adherence include an individualised session attendance check list given to the participant at baseline; where the dates of intervention have been negotiated and discussed between the researcher and the individual, and written on the checklist for the individual to take home.
Intervention code [1] 300522 0
Treatment: Other
Comparator / control treatment
No control group- uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305028 0
The primary outcome of the trial is feasibility. This will be assessed via a phone call conversation at week 12 (four weeks after completion of the exercise program) by one of the research team who has had no contact with the individual. Feasibility will be assessed by asking participants questions relating to the acceptability of the intervention and implementation of a manual technique protocol within an established pulmonary rehabilitation program. This is a composite outcome, The addition of focus groups at the completion of the trial is the other way we will capture feasibility of the intervention in terms of acceptability of intervention (by participants) and implementation of the intervention (from a participant and staff viewpoint). Focus groups will be conducted with the participants and the staff members who have been involved in the trial. There will be three focus groups for participants, and one focus group for physiotherapy department staff who are involved in the trial. A written feedback schedule was also added to capture any staff members who were unable to attend the staff focus groups.
Timepoint [1] 305028 0
Participants will still receive a phone call at week 12 (12 weeks post commencement of the intervention).

The focus groups will be conducted after the trial is completed for the participants and after data collection is completed with staff.
Secondary outcome [1] 343909 0
Health status assessed by COPD Assessment Test (CAT) questionnaire
Timepoint [1] 343909 0
Week 0 (baseline), and 8 and 12 weeks post commencement of the intervention
Secondary outcome [2] 343910 0
COPD survival prediction using the BODE Index. The tests involved in calculating the BODE Index include:
- BMI (height and weight)
- Lung obstruction tested by spirometer
- Dyspnea rating evaluated by mMRC
- Exercise capacity evaluated by the six minute walk test
Timepoint [2] 343910 0
Week 0 (baseline) and 8 weeks post commencement of the intervention
Secondary outcome [3] 343911 0
Composite outcome: Lung function and capacity as measured by a spirometer (tests: forced expiratory volume after one second and forced vital capacity)
Timepoint [3] 343911 0
Week 0 (baseline) and 8 weeks post commencement of the intervention
Secondary outcome [4] 343912 0
Exercise capacity measured by a six minute walk test
Timepoint [4] 343912 0
Week 0 (baseline) and 8 weeks post commencement of the intervention
Secondary outcome [5] 343913 0
Adverse events. These are assessed by the researcher and are patient reported each week. Examples of adverse events that may be expected include a COPD exacerbation, or muscular discomfort.
Timepoint [5] 343913 0
Adverse events will be assessed on a weekly basis from week 0 (baseline), and for eight weeks post commencement of the intervention. They will also be assessed at 12 weeks post post commencement of the intervention via telephone call..
Secondary outcome [6] 346696 0
Lung capacity as measured by inspiratory capacity. This is evaluated via spirometry testing
Timepoint [6] 346696 0
Inspiratory capacity will be assessed on a weekly basis from week 0 (baseline), and for eight weeks post commencement of the intervention.
Secondary outcome [7] 346697 0
Health status measured by Chronic Respiratory Questionnaire Self-Administered Individualised (CRQ-SAI) Questionnaire.
Timepoint [7] 346697 0
Week 0 (baseline), and 8 and 12 weeks post commencement of the intervention

Eligibility
Key inclusion criteria
• Written informed consent to participate
• Adults aged 40 years old and over
• Smokers, ex-smokers and non-smokers
• Meet GOLD criteria for moderate (GOLD II) to severe (GOLD III) COPD:
o GOLD II: Moderate 50% =FEV1 <80% predicted, FEV1 /FVC < 0.70
o GOLD III: Severe 30% =FEV1 <50% predicted, FEV1 /FVC < 0.70
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to fully participate in pulmonary rehabilitation
• Current rib or vertebral fracture
• Participated in manual therapy for Chronic Obstructive Pulmonary Disease in the previous one month.
• Current participation in manual therapy for the treatment of Chronic Obstructive Pulmonary Disease.
• Participated in pulmonary rehabilitation in the previous 12 months
• Physician diagnosed or patient reported severe osteoporosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The number of participants required is based on convenience sampling at the site, after considering the number of potentially eligible participants. The local site PR program assesses approximately 200 new patients annually, 50 per cent of whom have a diagnosis of COPD. There is an expected attrition rate of 20 per cent based on experience from previous PR studies at the hospital.

We anticipated that approximately 20 per cent of people undertaking PR would be eligible and consent to participate in this feasibility study and expected an attrition rate of approximately 20 per cent. Based on the available data, a convenience sample size of 26 participants was calculated to be recruited in one year (full-time recruitment). Allowing for a 20 per cent attrition rate and no replacement of dropouts, a sample size of 33 participants was determined, all of whom were allocated to a single intervention group.

Statistical methods involve: Characteristics of participants, feasibility outcomes of acceptability and safety in terms of adverse events will be calculated using descriptive statistics. Analysis of outcome data from baseline, mid-treatment, end of treatment and follow up will be made using within-person analysis over the time points

Assumptions for normality will be checked prior to analysis. Both per-protocol (PP) and intention-to-treat (ITT) analyses will be performed. For ITT analysis, multiple imputation method is used for missing data. All variables from Week 0 and Week 12 were included in the imputation model. There will be 20 imputations performed. Multiple imputation pattern analysis will be conducted to evaluate for monotonicity and to identify any random pattern to the missing data.

Paired t-tests will be used to compare normally distributed data for outcomes measured at Weeks 0 and 8, Weeks 0 and 12, and Weeks 8 and 12. Non-normally distributed data will be evaluated at those same time points using a Wilcoxon signed-rank test.

A one-way repeated measure (ANOVA) will be used to assess any differences over the three time points of Weeks 0, 8 and 12 for inspiratory capacity (IC) and HRQoL questionnaires (CAT questionnaire and CRQ-SAI). A PP analysis was conducted for these measures. An additional ITT analysis will be conducted for IC because it was measured both pre- and post-MET sessions across the duration of PR, and it directly relates to one of the research questions regarding changes in IC.

Effect size for a future larger RCT will be calculated using Cohen’s d effect size utilising IC. Sample size will be estimated for a power set to 80%, and significance level of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/02/2018
Date of last participant enrolment
Anticipated
7/07/2019
Actual
15/10/2019
Date of last data collection
Anticipated
31/10/2019
Actual
24/12/2019
Sample size
Target
33
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10256 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 21922 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 298867 0
University
Name [1] 298867 0
RMIT University
Country [1] 298867 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Rd, Bundoora VIC 3083
Country
Australia
Secondary sponsor category [1] 298074 0
Individual
Name [1] 298074 0
Danielle Baxter
Address [1] 298074 0
RMIT University
Plenty Rd, Bundoora VIC 3083
Country [1] 298074 0
Australia
Secondary sponsor category [2] 298154 0
Individual
Name [2] 298154 0
Johannah Shergis
Address [2] 298154 0
RMIT University
Plenty Road, Bundoora VIC 3083
Country [2] 298154 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299809 0
Austin Health LNR ethics committee
Ethics committee address [1] 299809 0
Ethics committee country [1] 299809 0
Australia
Date submitted for ethics approval [1] 299809 0
28/02/2017
Approval date [1] 299809 0
09/10/2017
Ethics approval number [1] 299809 0
HREC/16/Austin/474 Austin Health SITE REFERENCE Number: LNR 16/474

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81630 0
Dr Christopher Worsnop
Address 81630 0
Department of Respiratory & Sleep Medicine
Austin Hospital
145 Studley Rd
Heidelberg
Victoria
Australia, 3084
Country 81630 0
Australia
Phone 81630 0
+61 3 9496 3688
Fax 81630 0
Email 81630 0
[email protected]
Contact person for public queries
Name 81631 0
Danielle Baxter
Address 81631 0
RMIT University
School of Health and Biomedical Sciences
Plenty Road,
Bundoora
VIC 3083
Country 81631 0
Australia
Phone 81631 0
+61 3 9925 7647
Fax 81631 0
Email 81631 0
[email protected]
Contact person for scientific queries
Name 81632 0
Danielle Baxter
Address 81632 0
RMIT University
School of Health and Biomedical Sciences
Plenty Road,
Bundoora
VIC 3083
Country 81632 0
Australia
Phone 81632 0
+61 3 9925 7647
Fax 81632 0
Email 81632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a feasibility study and not making specific assertions about the therapeutic intervention, thus IPD will not be specifically available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePerceptions and experiences of a manual therapy trial: a qualitative study of people with moderate to severe COPD.2021https://dx.doi.org/10.1186/s12998-021-00387-0
N.B. These documents automatically identified may not have been verified by the study sponsor.