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Trial registered on ANZCTR


Registration number
ACTRN12618000316202
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
2/03/2018
Date last updated
5/06/2019
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive impairment in people with COPD - effect of pulmonary rehabilitation
Scientific title
Cognitive impairment in people with COPD - effect of pulmonary rehabilitation
Secondary ID [1] 294085 0
nil known
Universal Trial Number (UTN)
U1111-1209-5477
Trial acronym
n0
Linked study record
no

Health condition
Health condition(s) or problem(s) studied:
COPD 306649 0
Cognitive impairment 306790 0
Condition category
Condition code
Neurological 305751 305751 0 0
Other neurological disorders
Respiratory 305892 305892 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with COPD who enrol in pulmonary rehabilitation at RPAH will be asked to complete the Montreal Cognitive Assessment (MoCa) as well as the usual initial assessment (six-minute walk test plus measures of spirometry, quality of life and anxiety and depression), (T1)

They will attend pulmonary rehabilitation twice a week for 8 weeks and perform exercise training (20 minutes cycling, walking and upper and lower limb strength training).
Strength training will involve weight machines and theraband exercises and be based on the maximal weight a participant can perform for three sets of ten lifts. This will be progressed weekly as tolerated by the patient.
Target intensity for cycling and walking training is determined from the initial six-minute walk test. Walking training is set at 80% of the 6MWD and cycle training is set at 60% Wmax as calculated by the equation for cycle intensity developed by Hill et al 2008

All interventions will be set and supervised by the experienced pulmonary rehabilitation physiotherapists. Participants are closely supervised and monitored for pain, oxygen saturation, heart rate and level of both dyspnoea and exertion. Weekly exercise diaries will be kept to encourage participants to progress the exercise both at rehabilitation and at home

On completion of the 8 week rehabilitation program they will perform all assessments again including the MoCa (T3). Participants will be followed up 6 months following the completion of the 8 week pulmonary rehabilitation program (T4).
Between T3 and T4 participants will be encouraged to follow a home exercise program and complete an exercise diary (given to them in a booklet at the completion of the program). They will be invited to call at any time if they have an questions about the exercise training.

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.

Intervention code [1] 300356 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304825 0
The MoCa is an assessment tool delivered by the physiotherapist in a one to one session. It has been developed to assess cognitive function and the version used for this study is version 7.1` (original version)
Timepoint [1] 304825 0
Pre rehabilitation (T1),
End of rehabilitation (T3) [primary time point],
Six-month follow-up (T4)
Secondary outcome [1] 343304 0
Six-minute walk test is a measure of functional exercise capacity. It is widely used in pulmonary rehabilitation programs - participants are asked to walk as far as possible along a 30 m track, monitored with saturation and heart rate by the physiotherapist. two 6MWts are performed at all time points.
Timepoint [1] 343304 0
T1, T3, T4
Secondary outcome [2] 343305 0
St George's Respiratory Questionnaire is a questionnaire that is completed by the participant and measures health related quality of life. it is marked by a computerised marking system.
Timepoint [2] 343305 0
T1, T3, T4
Secondary outcome [3] 343306 0
COPD Assessment Tool is a questionnaire that is completed by the participant and measures quality of life. It is similar to the St George's respiratory questionnaire but focuses on patient symptoms
Timepoint [3] 343306 0
T1, T3, T4
Secondary outcome [4] 343307 0
Hospital Anxiety and Depression Score is a questionnaire completed by the participant that measures anxiety and depression
Timepoint [4] 343307 0
T1, T3, T4

Eligibility
Key inclusion criteria
COPD
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 that make it impossible to perform exercise training
Difficulty in reading and understanding english

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
34 participants will be required to have an 80% chance of detecting (as significant at the 5% level), a mean increase of 2 points by the end of pulmonary rehabilitation (minimal important difference)(Wong et al, 2017) in the MoCa, assuming a standard deviation of 2.9 points. (Krishnan et al, 2017) To account for a drop out of 15%, 38 participants will be recruited.

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] 10052 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 21569 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 298714 0
Hospital
Name [1] 298714 0
Royal Prince Alfred Hospital
Address [1] 298714 0
Royal Prince Alfred Hospital
50 Missenden Rd
Camperdown 2050 NSW
Country [1] 298714 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital
50 Missenden Rd
Camperdown 2050 NSW
Country
Australia
Secondary sponsor category [1] 297887 0
University
Name [1] 297887 0
University Sydney
Address [1] 297887 0
University Sydney
East St
Lidcombe 2141 NSW
Country [1] 297887 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299660 0
SLHD Ethics and Governance Committee
Ethics committee address [1] 299660 0
SLHD Ethics and Governance Committee
c/- Royal Prince Alfred Hospital
Medical Centre
Carillon Ave Newtown 2042 NSW
Ethics committee country [1] 299660 0
Australia
Date submitted for ethics approval [1] 299660 0
19/12/2017
Approval date [1] 299660 0
02/02/2018
Ethics approval number [1] 299660 0
X17-0395

Summary
Brief summary
The aim of this study is to determine if pulmonary rehabilitation will effect cognitive function in people with COPD

Participants will be invited to participate in the study when they perform the initial assessment for rehabilitation. All outcomes described will be collected (T1)

They will then attend rehabilitation twice a week for 8 weeks and perform exercise training and self-management education. Exercise training involved 20 minutes of cycling and 20 minutes of walking plus upper and lower limb strength training.

At completion of the rehabilitation program all outcomes will be reassessed (T3) and at six-months following the completion of pulmonary rehabilitation (T4)
Trial website
no
Trial related presentations / publications
no
Public notes

Contacts
Principal investigator
Name 81210 0
A/Prof Lissa Spencer
Address 81210 0
Physiotherapy Dept
Royal Prince Alfred Hospital
59 Missenden Rd
Camperdown NSW 2050
Country 81210 0
Australia
Phone 81210 0
+61 2 9515 9857
Fax 81210 0
+61 2 9515 9751
Email 81210 0
lissa.spencer@health.nsw.gov.au
Contact person for public queries
Name 81211 0
A/Prof Lissa Spencer
Address 81211 0
Physiotherapy Dept
Royal Prince Alfred Hospital
59 Missenden Rd
Camperdown NSW 2050
Country 81211 0
Australia
Phone 81211 0
61 2 9515 9857
Fax 81211 0
+61 2 9515 9751
Email 81211 0
lissa.spencer@health.nsw.gov.au
Contact person for scientific queries
Name 81212 0
A/Prof Lissa Spencer
Address 81212 0
Physiotherapy Dept
Royal Prince Alfred Hospital
59 Missenden Rd
Camperdown NSW 2050
Country 81212 0
Australia
Phone 81212 0
+61 2 9515 9857
Fax 81212 0
+61 2 9515 9751
Email 81212 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
The data is from one site and will be used for publication of results
Happy to share data if the occasion arises
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
No Results