Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000920392
Ethics application status
Approved
Date submitted
9/06/2017
Date registered
22/06/2017
Date last updated
13/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional assessment using the Glitttre Endurance Test in chronic obstructive pulmonary disease (COPD)
Scientific title
Evaluating functional capacity in people with chronic obstructive pulmonary disease (COPD) using the Glittre Endurance Test
Secondary ID [1] 292151 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 303592 0
Condition category
Condition code
Respiratory 303000 303000 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be an eight week pulmonary rehabilitation program in which participants will attend twice a week for exercise training in a gymnasium, The intervention will be delivered by physiotherapists with experience in pulmonary rehabilitation.

Pulmonary rehabilitation is part of usual care. Participants will attend two sessions per week for approximately 1 hour per session during which time they will perform 20 minutes of stationary cycling, 20 minutes of walking (over-ground or using a treadmill), 10 minutes of upper limb strength and endurance training (e.g. lat pull down and pect dec using a fixed weight machine for strength training and free weights for endurance training) and 10 minutes of lower limb strength training (e.g. quads and leg press using a fixed weight machine, sit to stand, steps, wall squats).

The intensity and duration of the exercises is based on the participant’s performance at their initial assessment. For walking training the initial intensity will be set at 80% of the six-minute walk test speed. For stationary cycling, the initial intensity will be set at 60 % of the peak work rate estimated using the distance walked in the best six-minute walk test based on the equation of Hill et al 2008.

Participants will exercise at their individually prescribed exercise intensity and duration but their exercise sessions will be in the gymnasium with other participants.

A number of tests of exercise capacity will be performed before and after the pulmonary rehabilitation program. These tests will be: the 6 minute walk test, the endurance shuttle walk test (ESWT) (Revill et al, 1999) and the Glittre Activities of Daily Living (Glittre ADL) test (Skumlien et al 2006) which are standard tests regularly used in pulmonary rehabilitation programs. Participants will perform one modified Glittre ADL test in which no weighted backpack will be worn. The study will also develop and evaluate a new test, the Glittre Endurance test, which will be a modification of the Glittre ADL test

The Glittre Endurance test will be performed on the same track as the Glittre ADL test. However, the Glittre Endurance test will be performed without a backpack. For this test participants will be asked to perform the test at a speed equivalent to 90% of the speed that achieved in the Glittre ADL test (without a backpack) and to keep going for as long as possible (to a maximum of 20 minutes) or until unable to keep up the pace. The pace will be set by an audio signal. No verbal encouragement will be given during the test. Participants will be asked to score their dyspnoea and rate of perceived exertion using the 0-10 category-ratio scale (Borg 1982) at the beginning and end of the test. Pulse rate and oxygen saturation (SpO2) will be measured during the test by a pulse oximeter. The test will be terminated at patients request or at the discretion of the clinician based on clinical signs and symptoms.

Energy expenditure will be measured during the Glittre Endurance test and the ESWT using an activity monitors, the Axivity AX3 (New Castle up on Tyne, UK) and the Actigraph GT1M (Pensacola, FL, USA).

Physical activity levels of participants before commencing the pulmonary rehabilitation program will be measured over seven days by wearing of the activity monitor.

Participants will be invited to participate and will be provided with the Participant Information Sheet and any questions arising will be answered by the physiotherapists involved in the study. After agreement, participants will be asked to sign the Participant Consent Form and to attend the pulmonary rehabilitation service for testing. The participation in the study is voluntary. Subjects can withdraw at any time without having to give a reason.

The intervention will be supervised so adherence will be monitored by attendance at exercise training sessions.
Intervention code [1] 298294 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302370 0
The responsiveness of the Glittre ADL and Glittre Endurance test as a functional outcome measure after pulmonary rehabilitation.
Timepoint [1] 302370 0
Baseline and after 8 weeks of pulmonary rehabilitation
Secondary outcome [1] 335747 0
The correlation of the Glittre Endurance test with daily physical activity.
Timepoint [1] 335747 0
At baseline the physical activity monitor will be worn for seven days and these data will be compared with the Glittre Endurance Test

Eligibility
Key inclusion criteria
Diagnosis of COPD (FEV1/FVC ratio < 0.7) with GOLD Stage I, II, III or IV disease severity.
Stable over the past month (i.e no admissions to hospital, change in medications or increase in respiratory symptoms).
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
. Concomitant cardiovascular, orthopaedic or neurological conditions that are likely to impair exercise performance
. Other significant pulmonary disease (e.g asthma)
. BMI > 35 kg/m2
. Major psychiatric illness
. In ability to understand English
. Inability to give informed consent
. Inability to perform or to understand the tests proposed for the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 50 participants will be sufficient to provide 80% power to detect as significant, at the 5% level, a minimum 150 seconds difference in the mean Glittre Endurance test after pulmonary rehabilitation, assuming a standard deviation (SD) of 250 seconds. These data are based on findings from the Endurance Shuttle Walk Test which is a test with similar constructs (Leung et al, 2010). This sample size will also be sufficient for the evaluation of the other aims of the project.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/07/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8314 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 8315 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 8316 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 8334 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 16378 0
2050 - Camperdown
Recruitment postcode(s) [2] 16379 0
2139 - Concord
Recruitment postcode(s) [3] 16380 0
2031 - Randwick
Recruitment postcode(s) [4] 16404 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 296686 0
Government body
Name [1] 296686 0
Scholarship from the Brazilian Government (CAPES)
Country [1] 296686 0
Brazil
Funding source category [2] 296687 0
Government body
Name [2] 296687 0
Department of Education and Training - Australian Endeavour Research Fellowship
Country [2] 296687 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 295643 0
University
Name [1] 295643 0
Federal University of Minas Gerais
Address [1] 295643 0
Av. Pres. Antônio Carlos, 6627 - Pampulha
Belo Horizonte - MG
31270-901
Brazil
Country [1] 295643 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297912 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 297912 0
Ethics committee country [1] 297912 0
Australia
Date submitted for ethics approval [1] 297912 0
26/04/2017
Approval date [1] 297912 0
17/05/2017
Ethics approval number [1] 297912 0
X14-0199 & HREC/14/RPAH/261

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1778 1778 0 0
/AnzctrAttachments/373096-Approval_letter_ethics.pdf (Ethics approval)
Attachments [2] 1779 1779 0 0
/AnzctrAttachments/373096-Information_for_Participants.doc (Participant information/consent)
Attachments [3] 1780 1780 0 0
/AnzctrAttachments/373096-Participant_Consent_Form.doc (Participant information/consent)

Contacts
Principal investigator
Name 75442 0
Prof Jennifer Alison
Address 75442 0
University of Sydney
Faculty of Health Sciences
PO Box 170, Lidcombe
Sydney
New South Wales
1825
Country 75442 0
Australia
Phone 75442 0
+612 9351 9371
Fax 75442 0
Email 75442 0
[email protected]
Contact person for public queries
Name 75443 0
Jennifer Alison
Address 75443 0
University of Sydney
Faculty of Health Sciences
PO Box 170, Lidcombe
Sydney
New South Wales
1825
Country 75443 0
Australia
Phone 75443 0
+61293519371
Fax 75443 0
Email 75443 0
[email protected]
Contact person for scientific queries
Name 75444 0
Jennifer Alison
Address 75444 0
University of Sydney
Faculty of Health Sciences
PO Box 170, Lidcombe
Sydney
New South Wales
1825
Country 75444 0
Australia
Phone 75444 0
+612 9351 9371
Fax 75444 0
Email 75444 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.