Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000167662
Ethics application status
Approved
Date submitted
8/02/2023
Date registered
17/02/2023
Date last updated
17/02/2023
Date data sharing statement initially provided
17/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of a telerehabilitation exercise program in people with chronic liver disease
Scientific title
A pilot study of telerehabilitation in people with chronic liver disease
Secondary ID [1] 308851 0
Nil known
Universal Trial Number (UTN)
U1111-1287-6196
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic Liver Disease 328855 0
Condition category
Condition code
Oral and Gastrointestinal 325852 325852 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Physical Medicine / Rehabilitation 325853 325853 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: A telerehabilitation exercise program for people with chronic liver disease.
Materials: Participants will be randomised to an intervention group (telerehabilitation group) or control group. The intervention participants will be provided with a hard and soft copy of a telerehabilitation exercise program. They will also receive a logbook to log compliance with the exercise program.
Procedures: All participants will undertake outcome measure testing before and after the intervention period. This will involve assessment of: strength (1 repetition maximum chest press, leg press and hand dynamometry), endurance (Vo2 peak graded treadmill test), anthropometry (ISAK restricted profile), health related quality of life (SF-12 questionnaire) and liver health (Liver function blood test and Fibroscan)
Who: The investigator will be an honours physiotherapy student. He will be supervised by a Curtin University Associate Professor (14 years) and Exercise Physiologist at Fiona Stanley Hospital/Royal Perth Hospital (25 years). Clinical Support will be provided by a practicing Gastroenterologist and Hepatologist at Fiona Stanley Hospital, Clinical Associate Professor and Research Fellow at The University of Western Australia, and Clinical Associate Professor at Curtin University.
Mode of delivery: Once prescribed the exercise program, participants will complete it independently, however, participants will be provided with 3 sessions of telerehabilitation. Telerehabilitation is where the investigator will engage with small groups (3 participants) of intervention participants using MS Teams. Participants and the investigator will engage using a video call on their own personal smart phone, laptop or tablet. Devices will not be provided by the study investigators.
Frequency of exercise: The exercise program will span 8 weeks. Participants will complete aerobic training 3x/week and strength training 2x/week. The telerehabilitation program will be supervised for 1 strength exercise session in week 3, 5 and 7. Aerobic training sessions will range from 15-30 minutes in length and the strength training sessions will be approximately 20 minutes long.
The aerobic exercise program will involve a moderate intensity walking program. Participants will begin with a moderate intensity 15-minute walk every aerobic training session for the first week of the intervention. For the first 4 weeks (week 1-4), walking duration will increase by 5 minutes every week until the participants are walking 30 minutes per session (i.e. week 1 walks will be 15 minutes in duration, week 2 walks 20 minutes in duration, week 3 walks 25 minutes in duration and week 4 walks 30 minutes in duration). For the last 4 weeks of the program (week 5-8), high intensity walking intervals will be progressively added each week, until the participant is walking 30 minutes at a high intensity. Walking intensity will be relative to participants’ baseline aerobic fitness and will be prescribed based on heart rate and rating of perceived exertion. Participants will be loaned polar monitors® to check their heart rate when completing aerobic training to ensure they are exercising at a moderate or high intensity. Furthermore, they will be instructed to use the Borg Rating of Perceived Exertion (Borg RPE) 6-20 scale for subjective moderate and high intensity of exercise. Moderate intensity walking will be at a Borg RPE of 11-13. High intensity walking will be at a Borg RPE of 14-16.
The strength training program will consist of a whole-body exercise program. Exercises will be completed using body weight and a resistance band/gymstick®. Participants will be loaned a gymstick® if they prefer or will be provided a resistance band for the exercises requiring a resistance band. For the first 4 weeks (week 1-4), moderate intensity exercises will be completed which include: standing up from a chair, resistance band rows in a long sitting position, mini squats, wall push ups, double leg calf raises, and leg raises with flexed knees in a supine position. The exercises will be completed in a circuit format with a 5-minute rest between sets. The participants should aim to exercise at a Borg RPE of 11-13. The 5-minute rest will be active recovery, where participants walk at low intensity (Borg RPE of 7-8). For the last 4 weeks (week 5-8), participants will partake in higher intensity exercises, which include standing up from a lower seat (or any other stable and lower surface), resistance band rows in a bent over standing position, lunges to ½ range, kneeling/ normal push-ups, single leg calf raises, and abdominal crunches. A circuit format and a 5-minute walking active recovery will be used again. Participant exercise intensity should be at a Borg RPE of 14-16. By increasing the intensity of the exercise program halfway through the intervention, it is anticipated that participants will have an improvement in strength due to progressive overload.
Location: Participants will complete the exercise program from home or a convenient location of their choice (eg a park or uncluttered gym). Initial prescription of the exercise program and outcome measure assessment will be completed at Fiona Stanley Hospital.
Personalisation: Participants will initially be prescribed an individualized exercise program at Fiona Stanley Hospital before undertaking the intervention. Intensity will be prescribed using the Borg RPE (6-20) scale and heart rate. During the 3 telerehabilitation sessions (in week 3,5 and 7) participants' exercise programs will be adapted to encourage training adaptations. Exercise intensity will be progressed or regressed by altering training volume, resistance, rest times and intensity of the exercise to maintain Borg RPE and heart rate in the target zones. If the participant's exercise program has been changed, they will be provided with a new soft copy of their exercise program.
Adherence: Participant adherence will be monitored using an exercise logbook, where participants log their compliance with the aerobic and strength training program. The investigator will count number of sessions attended to assess compliance with the exercise program. Adherence will be improved by providing 3 telerehabilitation sessions and a Facebook messenger group which will help foster team comradery and improved motivation.
Intervention code [1] 325387 0
Treatment: Other
Intervention code [2] 325388 0
Rehabilitation
Intervention code [3] 325389 0
Lifestyle
Comparator / control treatment
The control group will not receive the telerehabilitation exercise program but will be encouraged to maintain their usual activity level, They will receive usual care as prescribed by their physician with regard to their chronic liver disease.
Control group
Active

Outcomes
Primary outcome [1] 333785 0
Aerobic capacity as assessed by VO2 peak graded treadmill test (Modified Chronotropic Protocol).
Timepoint [1] 333785 0
Within 1 week before and after the intervention period
Primary outcome [2] 333786 0
Strength as assessed by One repetition maximum chest press, leg press and hand dynamometry.
Timepoint [2] 333786 0
Within 1 week before and after the intervention period
Primary outcome [3] 333787 0
Health-related quality of life as measured by the SF-12 Questionnaire
Timepoint [3] 333787 0
Within 1 week before and after the intervention period
Secondary outcome [1] 418297 0
Anthropometry as assessed by the International Society for the Advancement of Kinanthropometry (ISAK) restricted profile. Skinfold testing will be completed using calipers and girth measurements using an anthropometric measuring tape.
Timepoint [1] 418297 0
Within 1 week before and after the intervention period.
Secondary outcome [2] 418298 0
Compliance as assessed by an exercise logbook.
Timepoint [2] 418298 0
Within 1 week after the intervention period
Secondary outcome [3] 418299 0
Liver Health as assessed by a Liver function blood test
Timepoint [3] 418299 0
Within 1 week before and after the intervention period
Secondary outcome [4] 418300 0
Liver stiffness/structure as assessed by Transient elastography (Fibroscan)
Timepoint [4] 418300 0
Within 1 week before and after the intervention period.
Secondary outcome [5] 418581 0
Exercise program acceptability as assessed by Barriers and Facilitators Questionnaire
Timepoint [5] 418581 0
Within 1 week after intervention period

Eligibility
Key inclusion criteria
Diagnosis of compensated chronic liver disease, Outpatient from Fiona Stanley Hospital, Access to appropriate technology for telehealth appointments which may include a computer/smart phone/tablet that can download the MS Teams app®
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
De-compensation of chronic liver disease, The American College of Sports Medicine’s contraindications to completing an exercise program, Musculoskeletal conditions that will make the exercise program painful (including severe rheumatoid arthritis, severe low back pain and acute injuries such as ligament sprains)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using sealed opaque envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a feasibility study, no power calculations will be completed to calculate sample size.
A Shapiro-wilk test will be used to determine the normality of the scores. A paired samples t-test will be used to compare changes in outcomes over time if normally distributed. A Wilcoxson signed rank test will be used to compare changes in outcomes over time if not normally distributed. The statistical significance will be set at P<0.05

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/03/2023
Actual
Date of last participant enrolment
Anticipated
14/04/2023
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23956 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 39445 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 313074 0
University
Name [1] 313074 0
Curtin University
Country [1] 313074 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Dr, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 314764 0
None
Name [1] 314764 0
Address [1] 314764 0
Country [1] 314764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312322 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 312322 0
Ethics committee country [1] 312322 0
Australia
Date submitted for ethics approval [1] 312322 0
27/10/2022
Approval date [1] 312322 0
06/12/2022
Ethics approval number [1] 312322 0
RGS0000005780
Ethics committee name [2] 312400 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 312400 0
Ethics committee country [2] 312400 0
Australia
Date submitted for ethics approval [2] 312400 0
30/01/2023
Approval date [2] 312400 0
03/02/2023
Ethics approval number [2] 312400 0
HRE2023-0045

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

Contacts
Principal investigator
Name 124246 0
Prof Andrew Maiorana
Address 124246 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia 6150
Country 124246 0
Australia
Phone 124246 0
+61 433567369
Fax 124246 0
Email 124246 0
[email protected]
Contact person for public queries
Name 124247 0
Nikil Redipali
Address 124247 0
Curtin University
Kent St, Bentley WA 6102
Country 124247 0
Australia
Phone 124247 0
+61 401625121
Fax 124247 0
Email 124247 0
[email protected]
Contact person for scientific queries
Name 124248 0
Andrew Maiorana
Address 124248 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia 6150
Country 124248 0
Australia
Phone 124248 0
+61 433567369
Fax 124248 0
Email 124248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18292Study protocol    385297-(Uploaded-14-02-2023-17-48-29)-Study-related document.docx
18293Informed consent form    385297-(Uploaded-14-02-2023-17-46-02)-Study-related document.docx
18294Ethical approval    385297-(Uploaded-14-02-2023-17-39-37)-Study-related document.pdf



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.