Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000237987
Ethics application status
Approved
Date submitted
14/02/2020
Date registered
25/02/2020
Date last updated
16/06/2022
Date data sharing statement initially provided
25/02/2020
Date results information initially provided
14/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does exercise influence inflammation after a burn injury?
Scientific title
Does exercise influence burn induced inflammation?
Secondary ID [1] 300520 0
None
Universal Trial Number (UTN)
U1111-1248-0980
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn induced inflammation 316214 0
Condition category
Condition code
Inflammatory and Immune System 314505 314505 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 314621 314621 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6 week pulse of exercise:
- The resistance training (RT) regime will consist of six exercises targeting upper and lower major muscle groups. The RT intensity will be set at 3 sets of 10 repetitions. The resistance exercises will be progressive in nature whereby if a participant can perform an additional 2 repetitions in the final set for 2 consecutive sessions, the resistance will be increased by 5%. This progressive overload approach is widely used in resistance training programming to maximize the level of adaptation.
- Participants will complete 20 minutes of aerobic exercise (AE) utilizing a variety of exercise modes and equipment. Intensity for the AE will be prescribed at 70-90% of age predicted HR max with the average HR recorded at the end of each aerobic session.
- Participants will complete 3, 60 minute gym sessions each week (consisting of the above), supervised by a senior physiotherapist in the Fiona Stanley Hospital burns gym. Participants have individualised programs. Participants may complete their programs in the gym at the same time, however there will not be formalised group training sessions.

Feasibility: Participants may choose to undertake exercises at their local gym. If they do so, they will be, required to attend FSH at least once per week to enable appropriate progression of their exercises. Where this is not possible they will need to make contact with the supervising physiotherapist via phone to support appropriate progression of their exercise program. At a minimum, participants will need to be able to attend FSH for baseline measures, at the mid-way point, three weeks, and at completion of program (6 weeks) for data collection. Exercise tracking software such as Microsoft Band will be utilised for both groups to quantify activity when not at FSH. Physitrack app will be utilised by participants to record the exercise sessions they complete, in order to monitor adherence to the exercise sessions.
- It is a cross over trial. Participants will be initially randomised into either the control or exercise group. There will be a 4 week 'wash out' period between the control and exercise condition. The control condition will be asked to continue on with their normal activity, which will be tracked with activity monitors.
Intervention code [1] 316826 0
Treatment: Other
Intervention code [2] 316917 0
Rehabilitation
Comparator / control treatment
The study is a cross over trial, so each participant will complete and be monitored through a 6 week pulse of exercise and 6 week 'control' period where they continue with their normal daily routine. There will also be a 4 week rest period between the 2 different conditions (exercise and control).
Control group
Active

Outcomes
Primary outcome [1] 322831 0
TNF alpha - TNF alpha assay
Timepoint [1] 322831 0
TNF alpha will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e. the exercise and control conditions).
Secondary outcome [1] 379954 0
Physiological: non-invasive muscle mass bioimpedance spectroscopy (BIS). An impedimed BIS instrument will measure participants body mass by placing electrodes on intact skin on the hands and feet.
Timepoint [1] 379954 0
Secondary outcomes will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e. the exercise and control conditions).
Secondary outcome [2] 379984 0
Physical:
Grip strength - assessed using a dynamometer
Timepoint [2] 379984 0
Secondary outcomes will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e.both the exercise and control conditions).
Secondary outcome [3] 379985 0
Fitness/activity:
Modified Chester step test - participants step up and down a step in time with a beep. When they can no longer keep in time with the beep, the test is aborted and the level reached recorded. Heart rate and RPE Borg scale is recorded every minute.
Timepoint [3] 379985 0
Secondary outcomes will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e.both the exercise and control conditions).
Secondary outcome [4] 379986 0
Functional (subjective) recovery:
Quick Dash - the questionnaire will be completed by the participant

Timepoint [4] 379986 0
Secondary outcomes will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e.both the exercise and control conditions).
Secondary outcome [5] 379990 0
Quality of Life:
SF36- the questionnaire will be completed by the participant
Timepoint [5] 379990 0
Secondary outcomes will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e.both the exercise and control conditions).
Secondary outcome [6] 380345 0
Muscle Strength: assessed using a dynamometer
Timepoint [6] 380345 0
will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e.both the exercise and control conditions).
Secondary outcome [7] 380346 0
Fitness/activity:
International Physical Activity Questionnaire - the questionnaire will be completed by the participant
Timepoint [7] 380346 0
will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e.both the exercise and control conditions).
Secondary outcome [8] 380347 0
Fitness/activity: Wearable fitness tracker data - participants will asked to wear the activity tracker when at a minimum from when they are awake to when they go to bed in order to collect their daily steps
Timepoint [8] 380347 0
will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e.both the exercise and control conditions).
Secondary outcome [9] 380348 0
Functional (subjective): Lower limb functional Index - the questionnaire will be completed by the participant
Timepoint [9] 380348 0
will be collected at baseline, mid-way (3 weeks) and post intervention (6 weeks) for study periods 1 and 2 (i.e.both the exercise and control conditions).

Eligibility
Key inclusion criteria
• greater than or equal to 5%TBSA burn injury
• Time post injury, greater than or equal to 1 year
• Male or female, greater than or equal to18 years old
• Satisfactory self-described health status (excluding burn injury)
• Subject understands the proposed project, is able to consent to participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Acquired or pre-existing neurological injury or disease conditions which influence the capacity to complete future exercise or walking program eg nerve injury or multi-trauma; spinal cord injury, CVA / central nervous system lesions; Patients with no fixed address.
• Intellectually challenged patients
• Non – English speaking
• Pregnant Women
• Cancer
• Unstable cardiac conditions

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be utilised to determine which arm of the cross over trial the participants complete first. I.e wither the control or the exercise condition
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot and feasibility study planned to be completed in the FWF fellowship period (1 year). Current assumptions to estimate the sample size for this study, relates to data available from burn patient chronic TNF alpha levels, which were used to inform the assumptions of the calculation. If we had enough funding a sample size of 85 patients (allowing for 15% loss to follow up) would be required to achieve 80% power to detect a change in TNF alpha, with alpha set at 5% and with an effect size of 0.3. However, this is a pilot study (aim to recruit 20 participants), where we will aim to hone the assumptions relating to the sample size to achieve definitive study outcomes and improve the strength of future grant applications to fund other components of this trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2020
Actual
24/08/2020
Date of last participant enrolment
Anticipated
1/10/2020
Actual
5/04/2021
Date of last data collection
Anticipated
30/07/2021
Actual
30/06/2021
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15868 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 29317 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 304932 0
Charities/Societies/Foundations
Name [1] 304932 0
Fiona Wood Foundation
Country [1] 304932 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Drive, Murdoch, WA 6150
Country
Australia
Secondary sponsor category [1] 305285 0
None
Name [1] 305285 0
Address [1] 305285 0
Country [1] 305285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305341 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 305341 0
South Metropolitan Health Service Executive
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150
Ethics committee country [1] 305341 0
Australia
Date submitted for ethics approval [1] 305341 0
06/12/2019
Approval date [1] 305341 0
13/05/2020
Ethics approval number [1] 305341 0
EC00265

Summary
Brief summary
The primary aim of the study will be to longitudinally analyse the effect a 6-week pulse of exercise has on the level of inflammatory biomarkers including TNF alpha and a multiplex of other cytokines at different times frames (>1year) after burn. A cross-over trial will be conducted with participants randomised to either an exercise or control condition in the first phase. In the second phase participants will cross over into the alternate condition e.g phase 1 exercise condition participants will change over to the control condition in phase 2. Outcome measurement and blood sampling time points will be pre-intervention, at 3 weeks after commencement of intervention/control and then at 6 weeks (completion of study period 1). These will then be repeated in study period 2 at the same time points. Evidence suggests that exercise directly influences inflammation and immune function therefore we hypothesize the chronic inflammatory load after burn injury will decrease after 6 weeks of exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100058 0
Dr Pippa Kenworthy
Address 100058 0
Fiona Stanley Hospital
11 Robin Warren Drive, Murdoch, WA 6150
Country 100058 0
Australia
Phone 100058 0
+61 0432795838
Fax 100058 0
Email 100058 0
[email protected]
Contact person for public queries
Name 100059 0
Dr Pippa Kenworthy
Address 100059 0
Fiona Stanley Hospital
11 Robin Warren Drive, Murdoch, WA 6150
Country 100059 0
Australia
Phone 100059 0
+61 0432795838
Fax 100059 0
Email 100059 0
[email protected]
Contact person for scientific queries
Name 100060 0
Dr Pippa Kenworthy
Address 100060 0
Fiona Stanley Hospital
11 Robin Warren Drive, Murdoch, WA 6150
Country 100060 0
Australia
Phone 100060 0
+61 0432795838
Fax 100060 0
Email 100060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Investigators outside of the Department of Health will have access to the final study dataset with identification only by unique study number i.e de-identified. Trial results will be made publicly available through a series of peer reviewed journal articles.
When will data be available (start and end dates)?
December 2020 for the de-identified data set and September 2022 for published manuscripts
All data will be available for 7 years after publication
Available to whom?
As above - Investigators outside of the Department of Health will have access to the final study data set with identification only by unique study number i.e de-identified. Trial results will be made publicly available through a series of peer reviewed journal articles.
Available for what types of analyses?
To achieve the aims in the approved proposal; for future studies requiring the data set
How or where can data be obtained?
Access subject to approvals by Principal Investigator
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6877Study protocol  [email protected] Access subject to approvals by Principal Investiga... [More Details]
6878Statistical analysis plan  [email protected] Access subject to approvals by Principal Investiga... [More Details]
6879Informed consent form  [email protected]
6880Clinical study report  [email protected]
6881Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes exercise influence burn-induced inflammation: A cross-over randomised controlled feasibility trial.2022https://dx.doi.org/10.1371/journal.pone.0266400
N.B. These documents automatically identified may not have been verified by the study sponsor.