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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Lung function, quality of life and handgrip strength in adults with heart disease
Scientific title
Prediction of lung function and health-related quality of life using handgrip strength in cardiac patients
Secondary ID [1] 299509 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 314755 0
Condition category
Condition code
Cardiovascular 313084 313084 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 313085 313085 0 0
Physiotherapy
Respiratory 313344 313344 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 315788 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321656 0
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.
Timepoint [1] 321656 0
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).
Secondary outcome [1] 375790 0
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.
Timepoint [1] 375790 0
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).
Secondary outcome [2] 375792 0
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.
Timepoint [2] 375792 0
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).

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
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).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/11/2019
Actual
31/01/2020
Date of last participant enrolment
Anticipated
30/10/2020
Actual
31/03/2021
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
90
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14949 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 19258 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 28235 0
4814 - Douglas
Recruitment postcode(s) [2] 33838 0
4810 - Pimlico

Funding & Sponsors
Funding source category [1] 304003 0
University
Name [1] 304003 0
James Cook University
Country [1] 304003 0
Australia
Primary sponsor type
Individual
Name
Nnamdi Mgbemena
Address
Room 104, Building 41,
James Cook University,
1 James Cook Drive,
Douglas 4814,
Townsville, QLD.
Country
Australia
Secondary sponsor category [1] 304175 0
Individual
Name [1] 304175 0
Dr Anne Jones
Address [1] 304175 0
Building 43,
James Cook University,
1 James Cook Drive,
Douglas 4814, Townsville.
QLD.
Country [1] 304175 0
Australia
Secondary sponsor category [2] 304212 0
Individual
Name [2] 304212 0
A/Prof Anthony Leicht
Address [2] 304212 0
Building 43,
James Cook University,
1 James Cook Drive,
Douglas 4814, Townsville.
QLD.
Country [2] 304212 0
Australia
Secondary sponsor category [3] 304213 0
Individual
Name [3] 304213 0
Dr Siva Senthuran
Address [3] 304213 0
The intensive Care Unit,
The Townsville Hospital,
100 Angus Smith Drive,
Douglas 4814, Townsville,
QLD.
Country [3] 304213 0
Australia
Secondary sponsor category [4] 304214 0
Individual
Name [4] 304214 0
A/Prof Pankaj Saxena
Address [4] 304214 0
The Cardiothoracic Department,
The Townsville Hospital,
100 Angus Smith Drive,
Douglas 4814, Townsville,
QLD.
Country [4] 304214 0
Australia
Secondary sponsor category [5] 304215 0
Individual
Name [5] 304215 0
Jill Hergott
Address [5] 304215 0
The Cardiothoracic Department.
The Townsville Hospital,
100 Angus Smith Drive,
Douglas 4814, Townsville,
QLD.
Country [5] 304215 0
Australia
Secondary sponsor category [6] 304216 0
Individual
Name [6] 304216 0
Dr Nick Ang
Address [6] 304216 0
The Cardiothoracic Department,
The Townsville Hospital,
100 Angus Smith Drive,
Douglas 4814, Townsville,
QLD.
Country [6] 304216 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304495 0
Human Research Ethics Committee, Townsville Hospital and Health Service
Ethics committee address [1] 304495 0
Ethics committee country [1] 304495 0
Australia
Date submitted for ethics approval [1] 304495 0
24/05/2019
Approval date [1] 304495 0
25/07/2019
Ethics approval number [1] 304495 0
HREC/2019/QTHS/53274

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

Contacts
Principal investigator
Name 97150 0
Mr Nnamdi Mgbemena
Address 97150 0
Room 104, Building 41,
James Cook University,
1 James Cook Drive,
Douglas 4814,
Townsville, QLD.
Country 97150 0
Australia
Phone 97150 0
+61416044839
Fax 97150 0
Email 97150 0
nnamdi.mgbemena@my.jcu.edu.au
Contact person for public queries
Name 97151 0
Nnamdi Mgbemena
Address 97151 0
Room 104, Building 41,
James Cook University,
1 James Cook Drive,
Douglas 4814,
Townsville, QLD.
Country 97151 0
Australia
Phone 97151 0
+61416044839
Fax 97151 0
Email 97151 0
nnamdi.mgbemena@my.jcu.edu.au
Contact person for scientific queries
Name 97152 0
Nnamdi Mgbemena
Address 97152 0
Room 104, Building 41,
James Cook University,
1 James Cook Drive,
Douglas 4814,
Townsville, QLD.
Country 97152 0
Australia
Phone 97152 0
+61416044839
Fax 97152 0
Email 97152 0
nnamdi.mgbemena@my.jcu.edu.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 will not be shared in accordance with data privacy policies and to maintain confidentiality of participants.


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
EmbaseAcute changes in handgrip strength, lung function and health-related quality of life following cardiac surgery.2022https://dx.doi.org/10.1371/journal.pone.0263683
N.B. These documents automatically identified may not have been verified by the study sponsor.