Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000414516
Ethics application status
Approved
Date submitted
20/12/2023
Date registered
4/04/2024
Date last updated
23/06/2024
Date data sharing statement initially provided
4/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
PhysiotheRapy following OPen HEart SurgerY (PROPHESY)
Scientific title
PhysiotheRapy following OPen HEart SurgerY (PROPHESY): A feasibility study for measuring physical activity in patients undergoing cardiac surgery
Secondary ID [1] 310922 0
None
Universal Trial Number (UTN)
Trial acronym
PROPHESY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery via sternotomy 331983 0
Condition category
Condition code
Surgery 328725 328725 0 0
Other surgery
Cardiovascular 329275 329275 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will be recruited for this observational study pre-operatively (where able) or within 24 hours following open heart surgery. Physical activity levels of cardiac surgery patients will be measured via the use of a tri-axial acceleromter (ActiGraph) for 7 days post-operatively. Routine hospital level data (such as demographics, operative and post-operative data including physiotherapy interventions and discharge information) will be collected from electonric medical records. Aside from the fitting of the ActiGraph device to the patient's thigh, this study will not involve any deviation from usual care.
Intervention code [1] 327350 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336623 0
Recruitment
Timepoint [1] 336623 0
At completion of study
Primary outcome [2] 336624 0
Amount of activity data obtained
Timepoint [2] 336624 0
At completion of study
Primary outcome [3] 337094 0
Feasibility of data collection
Timepoint [3] 337094 0
At end of study
Secondary outcome [1] 429030 0
Length of Stay
Timepoint [1] 429030 0
ICU discharge
Secondary outcome [2] 429031 0
Cardiovascular endurance
Timepoint [2] 429031 0
On discharge from Physiotherapy and on day of hospital discharge
Secondary outcome [3] 430668 0
Physical function
Timepoint [3] 430668 0
On discharge from Physiotherapy and on day of hospital discharge
Secondary outcome [4] 430669 0
Physiotherapy service provision (number of physiotherapy interventions completed)
Timepoint [4] 430669 0
Hospital discharge
Secondary outcome [5] 430670 0
Patient activity levels
Timepoint [5] 430670 0
Day 7 or hospital discharge (which ever occurs first)
Secondary outcome [6] 433595 0
Length of stay
Timepoint [6] 433595 0
Hospital discharge

Eligibility
Key inclusion criteria
Adult patients undergoing open heart surgery via sternotomy where informed consent can be provided by the participant or an appropriate decision maker
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients mechanically ventilated for >20 hours post-operatively
- Patients with neurological impairments affecting the ability to mobilise (e.g. ABI, seizures)
- Patients with documented mobility restrictions
- Patients not able to ambulate independently (with or without a gait aid) prior to admission
- Patients who are unable to understand basic English

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In line with feasibility study guidelines outlined by Teresi et al. (2022), a 2-month recruitment timeframe was selected as a practical length of time with minimal interference with patient flow. We anticipate that in this timeframe there will be 70-100 eligible participants, which we deem to be sufficient to reasonably evaluate our feasibility outcomes.

Continuous variables will be summarised using mean ± standard deviation or median (interquartile range) according to data type and distribution. Categorical variables will be reported as counts and proportions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
1/06/2024
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
70
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25873 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 41706 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 315183 0
Hospital
Name [1] 315183 0
In-kind support from Victorian Heart Hospital Physiotherapy Department
Country [1] 315183 0
Australia
Primary sponsor type
Hospital
Name
Victorian Heart Hospital, Monash Health
Address
631 Blackburn Road, Clayton, Vic, 3168
Country
Australia
Secondary sponsor category [1] 317207 0
None
Name [1] 317207 0
Address [1] 317207 0
Country [1] 317207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314112 0
Monash Health HREC
Ethics committee address [1] 314112 0
Ethics committee country [1] 314112 0
Australia
Date submitted for ethics approval [1] 314112 0
12/12/2023
Approval date [1] 314112 0
30/05/2024
Ethics approval number [1] 314112 0
HREC/103925/MonH-2024-427490(v2)

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

Contacts
Principal investigator
Name 130454 0
Mr Jackson Wood
Address 130454 0
Victorian Heart Hospital, 631 Blackburn Road, Clayton, Vic, 3168
Country 130454 0
Australia
Phone 130454 0
+61 3 7511 1778
Fax 130454 0
Email 130454 0
Jackson.Wood@monashhealth.org
Contact person for public queries
Name 130455 0
Jackson Wood
Address 130455 0
Victorian Heart Hospital, 631 Blackburn Road, Clayton, Vic, 3168
Country 130455 0
Australia
Phone 130455 0
+61 3 7511 1778
Fax 130455 0
Email 130455 0
Jackson.Wood@monashhealth.org
Contact person for scientific queries
Name 130456 0
Michelle Paton
Address 130456 0
Victorian Heart Hospital, 631 Blackburn Road, Clayton, Vic, 3168
Country 130456 0
Australia
Phone 130456 0
+61 472 860 983
Fax 130456 0
Email 130456 0
Michelle.Paton@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified data regarding surgery type, in-patient and outcome information
When will data be available (start and end dates)?
data will not be made available until publication of results, data will be stored as per ethical requirements for 7 years from of end of study
Available to whom?
those undertaking research in related topics
Available for what types of analyses?
for IPDMA analysis
How or where can data be obtained?
available with appropriate data sharing agreement following direct contact with primary investigators (jackson.wood@monashhealth.org; michelle.Paton@monashhealth.org)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20984Study protocol  Jackson.Wood@monashhealth.org
20985Ethical approval  Jackson.Wood@monashhealth.org
20986Informed consent form  Jackson.Wood@monashhealth.org
21171Data dictionary  Michelle.Paton@monashhealth.org Data sharing agreement must be provided for consid... [More Details]



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.