None listed
Conditions
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.
Interventions
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 invest
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.
Sponsors
Monash University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
None
Outcome results
None listed