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Trial registered on ANZCTR


Registration number
ACTRN12618000327280
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
6/03/2018
Date last updated
5/03/2019
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive impairment in people with COPD or heart failure - effect of one session of exercise training
Scientific title
Cognitive impairment in people with COPD or heart failure - effect of one session of exercise training
Secondary ID [1] 294083 0
Nil known
Universal Trial Number (UTN)
U1111-1209-5387
Trial acronym
no
Linked study record
no

Health condition
Health condition(s) or problem(s) studied:
COPD 306647 0
Cognitive impairment 306810 0
Heart Failure 311879 0
Condition category
Condition code
Neurological 305749 305749 0 0
Other neurological disorders
Respiratory 305918 305918 0 0
Chronic obstructive pulmonary disease
Cardiovascular 310470 310470 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with COPD will be invited to participate in this study
If they agree they will be consented and randomised into either the intervention group (IG) or the control group (CG)
The IG will complete the Montreal Cognitive Assessment (MoCa) (measure of cognitive impairment), then perform 20 minutes walking on a treadmill (walk speed determined from 80% of the six-minute walk test). They will then complete the MoCa again. The MocCa is administered by the physiotherapist in a quiet room in the outpatients department and takes about 30 minutes maximum to deliver. The delivery is face to face and one on one.
The 6MWT is performed as part of initial assessment for pulmonary rehabilitation before recruitment occurs.

The MoCA has been used as a screening instrument for moderate cognitive impairment by assessing memory, language, executive functions, visuospatial skills, calculation, abstraction, attention, concentration and orientation. There are alternate forms of the MoCA and version 2 will be used at T2

Intervention code [1] 300355 0
Early detection / Screening
Intervention code [2] 313849 0
Rehabilitation
Comparator / control treatment
The Control group (CG) will perform the MoCa, then sit in a quiet room for 20 minutes and then perform the MoCa again. One observation will be made during quiet sitting and participants will be encouraged not to read or interact with their mobile phone during this time.
Control group
Active

Outcomes
Primary outcome [1] 304824 0
The Montreal Cognitive Assessment Tool (MoCa) is a questionnaire used to assess cognitive function (thinking and memory). MoCa Version 7.1 will be used at baseline (T1) before 20 minutes of treadmill walking or cycling and MoCa Version 7.2 will be used after the treadmill walking or cycling (T2).
Timepoint [1] 304824 0
T1 = baseline
T2 = end of 20 minutes of exercise
Secondary outcome [1] 343303 0
Heart rate will be measured using a finger probe connected to a portable oximeter
Timepoint [1] 343303 0
Every 5 minutes during treadmill walking
Secondary outcome [2] 343703 0
Oxygen saturation will be measured using a finger probe connected to a portable oximeter
Timepoint [2] 343703 0
Every 5 minutes during treadmill walking or cycling

Eligibility
Key inclusion criteria
Diagnosis of COPD or heart failure
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological or musculo skeletal problems - so unable to perform treadmill walking or stationary cycling.
Diagnosis of dementia
Inability to read and/or understand the MoCa questionnaire

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For the COPD group, 68 participants will be required to have an 80% chance of detecting (as significant at the 5% level), a mean increase of 2 points (minimum important difference) (Wong et al, 2017) in the MoCa, assuming a standard deviation of 2.9 points. (Krishnan et al, 2017). and allowing for a 15% dropout.
For the heart failure group, 62 participants will be required to have an 80% chance of detecting (as significant at the 5% level). A mean increase of 2 points (minimum important difference) (Wong et al., 2017) in the MoCa assuming a standard deviation of 2.6 points in heart failure patients (Gelow, Mudd, Chien & Lee, 2015) and allowing for a 15% drop out.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10051 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 21568 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 298713 0
Hospital
Name [1] 298713 0
Royal Prince Alfred Hospital
Address [1] 298713 0
Royal Prince Alfred Hospital
50 Missenden Rd
Camperdown NSW 2050
Country [1] 298713 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital
50 Missenden rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 297886 0
University
Name [1] 297886 0
University of Sydney
Address [1] 297886 0
University of Sydney
East St
Lidcombe NSW 2141
Country [1] 297886 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299659 0
Sydney Local Health District Ethics and Governance Committee
Ethics committee address [1] 299659 0
Sydney Local Health District Ethics and Governance Committee
c/- Royal Prince Alfred Hospital
Medical Centre
Carillon Ave Newtown 2042 NSW
Ethics committee country [1] 299659 0
Australia
Date submitted for ethics approval [1] 299659 0
28/11/2017
Approval date [1] 299659 0
05/12/2017
Ethics approval number [1] 299659 0
X17-0395

Summary
Brief summary
An amendment to the ethics committee to include people with heart failure was submitted on 28/11/2018 and approved on 17/12/2018.

The aim of the study is to determine if one session of exercise on a treadmill or cycle ergometer will alter the cognitive function in people with COPD or heart failure

Patients wit COPD or heart failure will be recruited from pulmonary rehabilitation and randomised via computerised randomisation generation to either the treadmill/cycle group or the quiet sitting group.

Participants complete the MoCa Version 7.1 and COPD participants will be asked to walk on the treadmill for 20 minutes at 80% of the average six-minute walk test speed calculated from the better of two six-minute walk tests. Participants with heart failure will be asked to cycle on a stationary cycle ergometer for 20 minutes at 60% of their peak exercise capacity calculated from the better of two six-minute walk tests. At completion of the exercise, participants will rest until oxygen saturation, heart rate and breathlessness returns to pre exercise levels. At this point participants will be asked to complete the MoCa Version 7.2, For the quiet sitting, participants will complete the MoCa version 7.1 and then be asked to sit in a quiet room and listen to music of their choice for 20 minutes, following which they will complete MoCa version 7.2. Two version of the MoCa will be used to control for test familiarity of repeated testing.
Trial website
no
Trial related presentations / publications
no
Public notes
no

Contacts
Principal investigator
Name 81206 0
A/Prof Lissa Spencer
Address 81206 0
Physiotherapy department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown 2050 NSW
Country 81206 0
Australia
Phone 81206 0
+61 2 9515 9857
Fax 81206 0
+61 2 9515 9751
Email 81206 0
lissa.spencer@health.nsw.gov.au
Contact person for public queries
Name 81207 0
A/Prof Lissa Spencer
Address 81207 0
Physiotherapy department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown 2050 NSW
Country 81207 0
Australia
Phone 81207 0
+61 2 9515 9857
Fax 81207 0
+61 2 9515 9751
Email 81207 0
lissa.spencer@health.nsw.gov.au
Contact person for scientific queries
Name 81208 0
A/Prof Lissa Spencer
Address 81208 0
Physiotherapy department
Royal Prince Alfred Hospital
Missenden Rd
Camperdown 2050 NSW
Country 81208 0
Australia
Phone 81208 0
+61 2 9515 9857
Fax 81208 0
+61 2 9515 9751
Email 81208 0
lissa.spencer@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data can not be shared unless further ethics approvals are provided
What supporting documents are/will be available?
No other documents available
Summary results
No Results