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Trial registered on ANZCTR


Registration number
ACTRN12618000514202
Ethics application status
Approved
Date submitted
13/03/2018
Date registered
9/04/2018
Date last updated
28/05/2019
Date data sharing statement initially provided
28/05/2019
Date results information initially provided
28/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Physical Activity in Venous Leg Ulcer Patients: an observational cohort study.
Scientific title
The effect of Physical Activity in Venous Leg Ulcer Patients: an observational cohort study.
Secondary ID [1] 294321 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12614000293662 - Main Study ASPiVLU RCT
ACTRN12618000236291 - Sub-study of ASPiVLU RCT

This record is a sub-study of ACTRN12618000236291.

Health condition
Health condition(s) or problem(s) studied:
Venous Leg Ulcer 307038 0
Condition category
Condition code
Cardiovascular 306138 306138 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 306139 306139 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This physical activity observational cohort study will examine association of physical activity (including sleep patterns) with time to healing and recurrence rates in people with VLUs using the accelerometer.

This proof of concept study will test the methodology of using the ActiSleep-BT accelerometer (ActiGraph, Pensacola, Florida) (accelerometer), recruitment feasibility and participant accelerometer acceptability in order to inform a large scale national clinical trial. It will also investigate the relationship between VLU healing and physical activity levels (including sleep patterns).

Participants will be recruited from the wound clinics in three Melbourne public hospitals currently recruiting for the ASPiVLU RCT (ACTRN12614000293662). Taking advantage of the screening process, patients ineligible for the ASPiVLU RCT are currently being recruited into the ASPIVLU Observational Cohort Study (ACTRN12618000236291). These patients will also be invited to participate in the ASPiVLU Physical Activity Observational Cohort Study.

Consenting patients will be followed for 24 weeks from the date of consent. The patient will be given questionnaires for completion at the baseline visit. Subsequent questionnaires will be mailed to the patient at 12 and 24 weeks from screen visit and followed up by phone if not returned within 2 weeks. Information will also be collected from the patient’s medical record. Between baseline and Week 12, participants will be asked to wear an accelerometer (for 7 days) and complete a physical activity questionnaire, keep a diary to record wake and sleep times and device removal greater than 15 minutes each day and evaluate the acceptability of wearing the accelerometer.
Intervention code [1] 300626 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305155 0
The primary outcome is time to healing of target ulcer at 12 weeks. Healing is defined as 100% epithelialisation with no exudate or scab. Time to healing will be measured in weeks from date of consent / enrolment.
Timepoint [1] 305155 0
12 weeks post-baseline
Secondary outcome [1] 344352 0
Time to healing of target ulcer: (24 week or until healed whichever comes first). Ulcer size and duration will be recorded from medical record wound assessment forms.
Timepoint [1] 344352 0
Until ulcer is healed, up to a maximum of 24 weeks post-baseline
Secondary outcome [2] 344353 0
Recurrence of target ulcer: (24 weeks) Absence of recurrence is defined as healed at 12 weeks and recurrence free at 24 weeks.
Timepoint [2] 344353 0
24 weeks post-baseline
Secondary outcome [3] 344354 0
Adherence to compression treatment: (12 and 24 weeks) Participants will be asked to report whether they adhere to wearing the compression on a categorical scale.
Timepoint [3] 344354 0
12 weeks and 24 weeks post-baseline
Secondary outcome [4] 344355 0
Health-related quality of life and wellbeing index: (Baseline, 12 and 24 weeks): The EQ-5D is a health related quality of life and wellbeing instrument.
Timepoint [4] 344355 0
12 weeks and 24 weeks post-baseline
Secondary outcome [5] 344356 0
Physical Activity: (Baseline, 12 and 24 weeks). Physical Activity will be assessed using the Rapid Assessment of Physical Activity (RAPA); a questionnaire which asks participants to select one of seven statements which describe light, moderate or vigorous activity levels.
Timepoint [5] 344356 0
12 weeks and 24 weeks post-baseline
Secondary outcome [6] 344357 0
Physical Activity: The International Physical Activity Questionnaires (IPAQ) will be used to assess kinds of physical activities that people do as part of their everyday lives which are considered to estimate total physical activity in MET-min/week and time spent sitting (REF below). Data will be collected at Baseline.
Timepoint [6] 344357 0
Baseline
Secondary outcome [7] 344358 0
Physical Activity: The ActiSleep-BT accelerometer (ActiGraph, Pensacola, Florida) will be used to collect physical activity and sleep data. Light-intensity physical activity, and moderate- to vigorous-intensity physical activity and sleep pattern characteristics will be assessed. Participants will be instructed to wear the ActiSleep-BT accelerometer (ActiGraph, Pensacola, Florida) for 7 days during the 12 weeks between Baseline and Week 12. Participants will be asked to complete a self-report daily log to record wake and sleep times and device removal for more than 15 minutes during the 7 days of accelerometer wear.
Timepoint [7] 344358 0
7 days during the 12 weeks between Baseline and Week 12
Secondary outcome [8] 344360 0
Feasibility and acceptability of using the accelerometer will be evaluated using a feed-back survey included in the self-reported daily log booklet. Items of interest include, ease of wear, placement, comfort during sleep, length of time worn and completion of daily log
Timepoint [8] 344360 0
At the end of the 7 days of accelerometer wear
Secondary outcome [9] 344361 0
Wound Pain Score: Participant’s self-reported assessment of pain associated with their VLU during the past week will be measured with an 11 point (0-10) numerical rating scale, where a score of ‘0’ represents no pain and a score of ‘10’ represents the maximum pain imaginable. Data will be collected at Baseline, 12 and 24 weeks.
Timepoint [9] 344361 0
12 weeks and 24 weeks post-baseline
Secondary outcome [10] 344362 0
Adherence to compression: Participants will be asked to report whether they adhere to wearing the compression on a categorical scale specific to this study of "wear every day", "wear most days (3 days per week or more)", "wear some days (less than 3 days per week)", "do not wear". Data will be collected at Baseline, 12 and 24 weeks. Information on compression use will also be collected from the patient’s medical history.
Timepoint [10] 344362 0
12 weeks and 24 weeks post-baseline

Eligibility
Key inclusion criteria
1. Age 18 years and older
2. Venous leg ulcers* present for at least six weeks or prior history of venous ulceration
* If patient has more than one wound, the largest at entry to study will be selected for measurement follow up
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As this is a pilot study, sample size calculations are not required (Larkin 2017). We plan to recruit 20-40 participants to test the feasibility of recruitment and determine sample size for a future large scale randomised control trial. It will also assess the feasibility and participant acceptability of wearing an accelerometer and data output from the ActiSleep –BT Accelerometer (Actigraph, Pensacola, Florida) as a means of assessing physical activity and sleep in venous leg ulcer patients as well as exploring the relationship between physical activity (including sleep) and healing outcomes in VLU patients.

Correlations with physical activity (including sedentary time) and sleep time will be assessed for the following variables: wound size, duration, healing rate (change in area over time up to 12 weeks), time to healing and time to first recurrence.
Data will be controlled for gender, age, smoking status, diabetes history, and BMI. Parametric and non-parametric tests will be used accordingly and statistical significance will be set at p=0.05. Post-hoc correction will be used to control for multiple comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10376 0
Caulfield Hospital - Caulfield
Recruitment hospital [2] 10377 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [3] 10378 0
The Alfred - Prahran
Recruitment postcode(s) [1] 22054 0
3162 - Caulfield
Recruitment postcode(s) [2] 22055 0
3081 - Heidelberg West
Recruitment postcode(s) [3] 22056 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 298966 0
Government body
Name [1] 298966 0
National Health and Medical Research Council
Address [1] 298966 0
GPO Box 1421
Canberra ACT 2601
Country [1] 298966 0
Australia
Funding source category [2] 298970 0
University
Name [2] 298970 0
Monash Nursing and Midwifery Strategic Grant
Address [2] 298970 0
School of Nursing and Midwifery
Level 3, 35 Rainforest Walk
Monash University
Wellington Road
Clayton, VIC 3800
Country [2] 298970 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Nursing and Midwifery
Level 3, 35 Rainforest Walk
Monash University
Wellington Road
Clayton, VIC 3800
Country
Australia
Secondary sponsor category [1] 298190 0
None
Name [1] 298190 0
Address [1] 298190 0
Country [1] 298190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299899 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 299899 0
99 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 299899 0
Australia
Date submitted for ethics approval [1] 299899 0
11/04/2017
Approval date [1] 299899 0
16/05/2017
Ethics approval number [1] 299899 0
HREC/14/Alfred/2 (Local Reference: Project 146/14)

Summary
Brief summary
The Physical Activity in Venous Leg Ulcer Patients pilot observational cohort study is a prospective multicentre observational cohort study to examine the feasibility of recruitment, the feasibility and acceptability of wearing an accelerometer and data output from the accelerometer as a means of assessing physical activity and sleep in venous leg ulcer patients.

Between 20-40 participants will be asked to wear the ActiSleep-BT accelerometer (ActiGraph, Pensacola, Florida) over a 7 day period between Baseline and Week 12 and complete a daily log to record wake and sleep times and actigraph removal greater than 15 minutes. A physical activity questionnaire (IPAQ) will be completed at Baseline and an acceptability survey will be completed at the end of the wear period. Participants will also be asked to complete a questionnaire at three time points (Baseline, Week 12 and Week 24) and their medical records will be accessed twice (Baseline and Week 24).

The primary objective is to determine if wound healing within 12 weeks from the baseline is associated with physical activity (and sleep) and the secondary objectives are: to examine factors related to ulcer healing and recurrence within 24 weeks and to examine study feasibility and patient accelerometer wear acceptability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81918 0
Prof Carolina Weller
Address 81918 0
Monash University
School of Nursing and Midwifery
Level 3, 35 Rainforest Walk
Wellington Road
Clayton, VIC 3800
Country 81918 0
Australia
Phone 81918 0
+61 3 9903 0623
Fax 81918 0
Email 81918 0
carolina.weller@monash.edu
Contact person for public queries
Name 81919 0
Prof Carolina Weller
Address 81919 0
Monash University
School of Nursing and Midwifery
Level 3, 35 Rainforest Walk
Wellington Road
Clayton, VIC 3800
Country 81919 0
Australia
Phone 81919 0
+61 3 9903 0623
Fax 81919 0
Email 81919 0
carolina.weller@monash.edu
Contact person for scientific queries
Name 81920 0
Prof Carolina Weller
Address 81920 0
Monash University
School of Nursing and Midwifery
Level 3, 35 Rainforest Walk
Wellington Road
Clayton, VIC 3800
Country 81920 0
Australia
Phone 81920 0
+61 3 9903 0623
Fax 81920 0
Email 81920 0
carolina.weller@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No Plans to share individual participant data
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary