Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000437561
Ethics application status
Approved
Date submitted
8/03/2024
Date registered
10/04/2024
Date last updated
28/07/2024
Date data sharing statement initially provided
10/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Tele-Prehabilitation in improving outcomes for patients with major abdominal and thoracic surgery compared to face-to-face prerehabilitation
Scientific title
Effectiveness of Tele-Prehabilitation in reducing hospital length of stay and minimising postoperative complications in patients with major abdominal and thoracic surgery compared to face-to-face prerehabilitation: A randomised controlled trial
Secondary ID [1] 311700 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal surgery 333165 0
Thoracic surgery 333292 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329859 329859 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tele-prehabilitation: at an initial consultation, participants will receive a physical, nutritional, and psycho-social assessment via telehealth. The initial 60-minute face-to-face assessments will be carried out by the physiotherapist and the dietitian. The initial assessment will aim to obtain basic patient demographic data. Exercise tolerance, frailty, quality of life, and nutritional status (using a malnutrition screening tool) will be measured or recorded. Exercise prescription will be based on the 6-minute walk test (6MWT) and 1 repetition maximum (1RM) findings. A 60-minute exercise program will be offered in a group setting via Telehealth two days a week. The group class will have up to 5 patients at any time. If the class size gets bigger, then an additional class will be added to accommodate the remaining clients. It will consist of strength and endurance training, such as walking and upper and lower limb resistance training using resistance bands and the patient's own body weight. In addition, patients will also practice breathing exercises and forced expiratory techniques such as deep breathing exercises and coughing. Patients will exercise at moderate intensity guided by the Borg scale. Exercise attendance will be recorded on the patient's exercise sheet. Diet and nutritional advice will be provided by the dietitian based on individual nutritional screening results. A single 20-30 minutes consultation will be provided via Tele-health and dietary recommendations will be provided (via email or post). Provision for an individualised food diary will be outside the scope of this program. In addition to two days of supervised exercise, participants will be encouraged to complete a 30-45 minute home exercise program on any three days a week, which may include walking, upper limb and lower limb strengthening exercises and breathing exercises. The home exercise program will be recorded in the patient's home exercise diary (self-recorded). Education will be provided via pre-recorded education sessions by a dietitian, pain clinical nurse consultant (CNC), social worker, pharmacist, and physiotherapist where each education will be of 10-15 minute duration for patients to watch in their own time. patients will be encouraged to watch all the videos if possible and record in their home exercise program diary. The pre-recorded videos will be provided via a USB device or pre-loaded on a tablet device (to be provided to patients with no smart device). During telehealth consults, the physiotherapist will follow up with participants regarding questions arising from the education sessions and organise a telephone consult with the relevant professional if needed. Participants will also receive a comprehensive handbook covering all the information delivered in the education sessions, along with a home exercise program and exercise diary. This booklet is designed for this program by the health professionals who are involved in service delivery. The exercise program will be offered for 2-6 weeks (The duration will be based on the program start date till the date of surgery). The program duration will vary for each participant/client depending on the date of surgery.
Intervention code [1] 328163 0
Treatment: Other
Comparator / control treatment
Prehabilitation group (control): Participants will attend an initial face-to-face assessment, including physical, nutritional, and psycho-social assessments same as the telerehabilitation group. The initial 60-minute assessments will be carried out by the physiotherapist and the dietitian face-to-face. Exercise tolerance, frailty, quality of life, and nutritional status (using a malnutrition screening tool) will be measured or recorded. Exercise prescription will be based on the 6-minute walk test (6MWT) and 1 repetition maximum (1RM) findings. A single 20-30-minute consultation will be provided with dietary recommendations. Provision for an individualised food diary will be outside the scope of this program. A 60-minute exercise program will be offered in a group setting in a gymnasium two days a week. The group size will be kept to 5 participants to allow safe monitoring and supervision in the gymnasium. It will consist of strength and endurance training, such as walking on a treadmill or flat walk track, exercise bike and upper and lower limb resistance training using free weights and exercises using the patient's own body weight. Patients will exercise at moderate intensity guided by the Borg scale. In addition, patients will also practice breathing exercises and forced expiratory techniques such as deep breathing exercises and coughing. Exercise attendance will be recorded on the patient's exercise sheet. Diet and nutritional advice will be provided by the dietitian based on individual nutritional screening results. Participants will be encouraged to complete a 30-45 minute home exercise program on any three days a week, which includes walking, upper limb and lower limb strengthening exercises. The home exercise program will be recorded in the patient's home exercise diary (self-recorded). Education will be provided face to face by a dietitian, pain clinical nurse consultant (CNC), social worker, pharmacist, and physiotherapist where each education will be of 10-15 minute duration. The exercise program will be offered for a 2-6 week period. (The duration will be based on the program start date till the date of the surgery). The program duration will vary for each participant/client depending on the date of surgery.
Control group
Active

Outcomes
Primary outcome [1] 337637 0
Hospital length of stay
Timepoint [1] 337637 0
From the time of surgery to discharge from hospital
Secondary outcome [1] 432587 0
Postoperative complications: pneumonia, pulmonary atelectasis and pulmonary embolism
Timepoint [1] 432587 0
From the time of admission to up to 28 days post-hospital discharge
Secondary outcome [2] 433118 0
28-day hospital readmission
Timepoint [2] 433118 0
From hospital discharge to up to 28 days post-hospital discharge
Secondary outcome [3] 433119 0
Unplanned ICU admission
Timepoint [3] 433119 0
ICU admission during the hospital stay
Secondary outcome [4] 433120 0
Need for mechanical ventilation >48 hours
Timepoint [4] 433120 0
From the time of intubation and mechanical ventilation to the time of extubation
Secondary outcome [5] 433121 0
30-day mortality
Timepoint [5] 433121 0
At 30 days after hospital discharge from the first admission
Secondary outcome [6] 433122 0
Quality of life
Timepoint [6] 433122 0
2 weeks post hospital discharge
Secondary outcome [7] 433123 0
Comparative cost of intervention
Timepoint [7] 433123 0
On completion of study
Secondary outcome [8] 433541 0
ICU length of stay
Timepoint [8] 433541 0
From time of ICU admission to discharge to the wards or home
Secondary outcome [9] 433542 0
90-day mortality
Timepoint [9] 433542 0
90 days post-hospital discharge

Eligibility
Key inclusion criteria
• Age : 18 years and above
• Major abdominal surgery; upper GI, lower GI, colorectal surgery
• Open hernia repair, or laparoscopy for patients 60 yrs and above
• Cardiothoracic surgery; lobectomy, pulmonary wedge resection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who cannot attend face-to-face sessions or telehealth.
• Patients who cannot follow instructions due to impaired cognitive/intellectual capacity.
• Patients unable to exercise (e.g. impaired musculoskeletal function/injuries)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
computer generated central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random concealed using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
23/04/2024
Date of last participant enrolment
Anticipated
15/05/2025
Actual
Date of last data collection
Anticipated
18/08/2025
Actual
Sample size
Target
90
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316029 0
University
Name [1] 316029 0
The University of Sydney
Country [1] 316029 0
Australia
Primary sponsor type
Other
Name
Dr Sviatlana Kamarova
Address
Country
Australia
Secondary sponsor category [1] 318181 0
University
Name [1] 318181 0
The university of Sydney, Sydney Health partners (partial funding)
Address [1] 318181 0
Country [1] 318181 0
Australia
Secondary sponsor category [2] 318298 0
University
Name [2] 318298 0
Nepean Blue Mountains Local Health District
Address [2] 318298 0
Country [2] 318298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314852 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 314852 0
Ethics committee country [1] 314852 0
Australia
Date submitted for ethics approval [1] 314852 0
05/09/2023
Approval date [1] 314852 0
28/09/2023
Ethics approval number [1] 314852 0
2023/ETH01511

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

Contacts
Principal investigator
Name 132930 0
Dr Sviatlana Kamarova
Address 132930 0
Nepean school building, Derby Street, Penrith 2747, NSW
Country 132930 0
Australia
Phone 132930 0
+61 435796165
Fax 132930 0
Email 132930 0
[email protected]
Contact person for public queries
Name 132931 0
Anwar Hassan
Address 132931 0
Physiotherapy Department, Nepean Hospital, Derby Street, Penrith 2747, NSW
Country 132931 0
Australia
Phone 132931 0
+61 413813577
Fax 132931 0
Email 132931 0
[email protected]
Contact person for scientific queries
Name 132932 0
Anwar Hassan
Address 132932 0
Physiotherapy Department, Nepean Hospital, Derby Street, Penrith 2747, NSW
Country 132932 0
Australia
Phone 132932 0
+61413813577
Fax 132932 0
Email 132932 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• It will be assessed case by case

Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentified patient demographics and outcomes may be shared on request

What types of analyses could be done with individual participant data?
• For scientific studies

When can requests for individual participant data be made (start and end dates)?
From:
data will be available 6 months post-completion of the study and available for 5 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• From the study principal investigators
[email protected]
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21920Study protocol https://osf.io/uz7nv/files/osfstorage 



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.