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Trial registered on ANZCTR
Registration number
ACTRN12619001515189
Ethics application status
Approved
Date submitted
15/10/2019
Date registered
1/11/2019
Date last updated
3/05/2021
Date data sharing statement initially provided
1/11/2019
Date results information initially provided
3/05/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Lung function, quality of life and handgrip strength in adults with heart disease
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Scientific title
Prediction of lung function and health-related quality of life using handgrip strength in cardiac patients
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Secondary ID [1]
299509
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease
314755
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Condition category
Condition code
Cardiovascular
313084
313084
0
0
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Coronary heart disease
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Physical Medicine / Rehabilitation
313085
313085
0
0
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Physiotherapy
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Respiratory
313344
313344
0
0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Cardiovascular or cardiac diseases are range of conditions that affect the heart and blood vessels and are the leading cause of death worldwide. Cardiac diseases are regarded as “an inflammatory state”; previous studies have shown a significant relationship between high pre-operative inflammatory blood markers and increased mortality in these patients. This inflammatory reaction usually lasts up to six weeks in patients after discharge following both coronary artery by-pass graft (CABG) and valvular replacement surgeries, which are the most common cardiac surgical procedures. This study will observe consenting adults who have cardiac disease and will undergo cardiac surgery. These four time-points are before the surgery, at the time of discharge from the hospital, at six weeks and at six months after surgery.
Participants will be given informed consent form to read and give their consent if they are happy to participate in the study. Consenting participants' handgrip strength, lung function and health-related quality of life will be assessed at these four time points. These assessments will take approximately 30 minutes per session.
Handgrip strength assessment involves the isometric contraction of the muscles of the forearm and hand using a hand dynamometer which reads off the grip strength after gripping. This test takes approximately 10 minutes per session to complete. Lung function assessment involves forced expiratory manoeuvre into a spirometer in order to measure the forced vital capacity, forced expiratory volume in one second and peak expiratory flow rate. Lung function assessment takes 10-15 mins per session to complete. Health-related quality of life will be assessed using the Short Form 36 medical outcome questionnaire. Filling out this questionnaire takes approximately 15 minutes per session to complete. Some of the demographic and clinical parameters (e.g height, weight, age, type of surgery e.t.c) will also be obtained from the participant's medical record.
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Intervention code [1]
315788
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
321656
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Handgrip strength (HGS) - measure of the global muscle strength and obtained by contracting the muscles of the forearm and the hand.
HGS will be measured in kilograms using a hand dynamometer.
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Assessment method [1]
321656
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Timepoint [1]
321656
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HGS as the primary outcome will be assessed in participants at four time-points. These time-points are 2-3 days before cardiac surgery (primary start-point), at the point of discharge from the hospital, at six weeks and at six months after cardiac surgery (primary endpoint).
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Secondary outcome [1]
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A secondary composite outcome, lung function, specifically forced vital capacity (FVC), forced expiratory flow rate in one second (FEV1) and peak expiratory flow rate (PEFR) will be assessed..
These parameters will be assessed using a spirometer (Vitalograph Alpha) as the participant performs a forced expiratory manouevre.
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Assessment method [1]
375790
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Timepoint [1]
375790
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Likewise, lung function will be assessed in the participants at the aforementioned four time-points (i.e. 2-3 days before cardiac surgery, at the point of discharge from the hospital, at six weeks and at six months after cardiac surgery).
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Secondary outcome [2]
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Another secondary outcome, health-related quality of life (HRQoL) will be assessed and this will be based on patients' personal expectations as they carry out their activities of daily living.
This outcome will be assessed using a questionnaire, the short form-36 health survey.
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Assessment method [2]
375792
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Timepoint [2]
375792
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This outcome will also be assessed at the aforementioned four time-points (i.e. 2-3 days before cardiac surgery, at the point of discharge from the hospital, at six weeks and at six months after cardiac surgery).
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Eligibility
Key inclusion criteria
a) patients who have been diagnosed with cardiac disease (e.g. coronary artery disease, valvular heart disease, combined heart diseases) and will undergo surgery at the Townsville Hospital;
b) patients who comprehend, read and speak English
c) patients who are consenting adults (=>18 years).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
a) patients undergoing emergency cardiac surgery.
b) patients who are pregnant.
c) patients who have neuromuscular weakness as a result of a pre-existing diagnosis.
d) patients who are involved in clinical trials where they currently take medications/interventions known to impact on the variables of interest in the current study (e.g. trials in muscular dystrophy).
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Based on the equation by Walter, Eliasziw & Donner (1998) for determining sample sizes in observational studies, a minimum of 66 patients will be involved in this study (power of 90%, p<0.05). Subsequently, 90 patients will be recruited for this study to account for up to 35% drop-outs.
The demographic details of patients will be summarised as mean (standard deviation) for normally distributed data and median (inter quartile range [IQR]) for non-normally distributed data. Comparison of variables at four different time points will be conducted via repeated- measures analysis of variance (ANOVA). Pearson product moment correlation analysis will be conducted to determine the relationship between HGS (as an independent variable), lung function and HRQoL (as dependent variables). Multiple regression will be employed to model HGS and other significant predictors of lung function and HRQoL at pre-operation, PT discharge, at six weeks and six months after PT discharge. The level of significance will be set at <0.05 for all analyses. All data will be analysed using SPSS version 25.0 (IBM Inc, Chicago IL).
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
4/11/2019
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Actual
31/01/2020
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Date of last participant enrolment
Anticipated
30/10/2020
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Actual
31/03/2021
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Date of last data collection
Anticipated
30/09/2021
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Actual
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Sample size
Target
90
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
14949
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The Townsville Hospital - Douglas
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Recruitment hospital [2]
19258
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Mater Hospital Pimlico - Pimlico
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Recruitment postcode(s) [1]
28235
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4814 - Douglas
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Recruitment postcode(s) [2]
33838
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4810 - Pimlico
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Funding & Sponsors
Funding source category [1]
304003
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University
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Name [1]
304003
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James Cook University
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Address [1]
304003
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1 James Cook Drive,
Douglas 4814, Townsville,
QLD
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Country [1]
304003
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Australia
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Primary sponsor type
Individual
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Name
Nnamdi Mgbemena
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Address
Room 104, Building 41,
James Cook University,
1 James Cook Drive,
Douglas 4814,
Townsville, QLD.
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Country
Australia
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Secondary sponsor category [1]
304175
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Individual
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Name [1]
304175
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Dr Anne Jones
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Address [1]
304175
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Building 43,
James Cook University,
1 James Cook Drive,
Douglas 4814, Townsville.
QLD.
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Country [1]
304175
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Australia
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Secondary sponsor category [2]
304212
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Individual
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Name [2]
304212
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A/Prof Anthony Leicht
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Address [2]
304212
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Building 43,
James Cook University,
1 James Cook Drive,
Douglas 4814, Townsville.
QLD.
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Country [2]
304212
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Australia
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Secondary sponsor category [3]
304213
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Individual
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Name [3]
304213
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Dr Siva Senthuran
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Address [3]
304213
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The intensive Care Unit,
The Townsville Hospital,
100 Angus Smith Drive,
Douglas 4814, Townsville,
QLD.
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Country [3]
304213
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Australia
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Secondary sponsor category [4]
304214
0
Individual
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Name [4]
304214
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A/Prof Pankaj Saxena
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Address [4]
304214
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The Cardiothoracic Department,
The Townsville Hospital,
100 Angus Smith Drive,
Douglas 4814, Townsville,
QLD.
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Country [4]
304214
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Australia
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Secondary sponsor category [5]
304215
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Individual
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Name [5]
304215
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Jill Hergott
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Address [5]
304215
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The Cardiothoracic Department.
The Townsville Hospital,
100 Angus Smith Drive,
Douglas 4814, Townsville,
QLD.
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Country [5]
304215
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Australia
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Secondary sponsor category [6]
304216
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Individual
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Name [6]
304216
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Dr Nick Ang
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Address [6]
304216
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The Cardiothoracic Department,
The Townsville Hospital,
100 Angus Smith Drive,
Douglas 4814, Townsville,
QLD.
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Country [6]
304216
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304495
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Human Research Ethics Committee, Townsville Hospital and Health Service
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Ethics committee address [1]
304495
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The Townsville Hospital,
100 Angus Smith Drive,
Douglas 4814, Townsville,
QLD.
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Ethics committee country [1]
304495
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Australia
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Date submitted for ethics approval [1]
304495
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24/05/2019
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Approval date [1]
304495
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25/07/2019
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Ethics approval number [1]
304495
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HREC/2019/QTHS/53274
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Summary
Brief summary
Previous research has showed a reduced lung function after cardiac surgery and this has been associated with increased mortality and morbidity. The aim of this prospective, observational study is to determine if a cheap and simple tool like HGS could be an indicator of lung function and health-related quality of life after cardiac surgery. It is hypothesized that HGS will be a simple and valid method to monitor lung function and health-related quality of life during post-hospital recovery in cardiac patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Nnamdi Mgbemena
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Address
97150
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Room 104, Building 41,
James Cook University,
1 James Cook Drive,
Douglas 4814,
Townsville, QLD.
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Country
97150
0
Australia
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Phone
97150
0
+61416044839
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Fax
97150
0
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Email
97150
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[email protected]
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Contact person for public queries
Name
97151
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Mr Nnamdi Mgbemena
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Address
97151
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Room 104, Building 41,
James Cook University,
1 James Cook Drive,
Douglas 4814,
Townsville, QLD.
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Country
97151
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Australia
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Phone
97151
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+61416044839
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Fax
97151
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Email
97151
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[email protected]
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Contact person for scientific queries
Name
97152
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Mr Nnamdi Mgbemena
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Address
97152
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Room 104, Building 41,
James Cook University,
1 James Cook Drive,
Douglas 4814,
Townsville, QLD.
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Country
97152
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Australia
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Phone
97152
0
+61416044839
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Fax
97152
0
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Email
97152
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data will not be shared in accordance with data privacy policies and to maintain confidentiality of participants.
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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
Source
Title
Year of Publication
DOI
Embase
Acute changes in handgrip strength, lung function and health-related quality of life following cardiac surgery.
2022
https://dx.doi.org/10.1371/journal.pone.0263683
N.B. These documents automatically identified may not have been verified by the study sponsor.
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