None listed
Conditions
Brief summary
Aim/s, hypothesis and /or research question This is primarily a feasibility study to ascertain the achievability of larger scale studies involving the use of activity trackers in joint replacement (and potentially other operations) patients. Primary aim: 1. To investigate the association between PA and SB and postoperative outcomes (pain, function, quality of life, complications) and determine the composition of PA and SB (including the intensity of PA and time spent sitting, standing and sleeping) associated with better postoperative outcomes. Secondary aim: 1. Investigate the association between preoperative PA and SB and preoperative health status (pain, function, quality of life) 2. Characterise and compare PA and SB (including the intensity of PA and time spent sitting, standing, stepping, sleeping, number of sit-to-stand transitions per day, number of bouts of prolonged sitting >30 min) in patients undergoing hip or knee replacement in the preoperative, immediate-postoperative and 3-month postoperative stages Evidence gathered from the proposed study will be used to initiate a program of research to inform the design and implementation of larger multicentre observational and interventional studies with larger numbers of the participants and extended follow up periods. Primary hypothesis: Post-operative outcomes will be associated with PA and SB and will be influenced by the intensity of PA performed and the amount of sedentary time. Those with higher levels of pre-operative activity will be less likely to have post-operative complications, and the inverse relating to sedentary time.
Interventions
Physical activity and sedentary behaviour will be measured using two wearable devices that capture a diverse range of activities including sleep and activity intensity.
The thigh-mounted activPAL micro inclinometer (PAL Technologies Ltd, Glasgow, UK) will measure time spent lying, sitting, standing and stepping and will be worn for eight consecutive days at each assessment time point. The activPAL is a small, lightweight monitor worn on thigh that detects limb position using an inclinometer. The
Physical activity and sedentary behaviour will be measured using two wearable devices that capture a diverse range of activities including sleep and activity intensity. The thigh-mounted activPAL micro inclinometer (PAL Technologies Ltd, Glasgow, UK) will measure time spent lying, sitting, standing and stepping and will be worn for eight consecutive days at each assessment time point. The activPAL is a small, lightweight monitor worn on thigh that detects limb position using an inclinometer. The activPAL is attached using waterproof Tegaderm dressing. Raw data will be downloaded using activPAL proprietary software into event files and then processed using the ProcessingPAL software (University of Leicester, Leicester, UK) using algorithms developed for adults to determine daily sitting, standing, stepping and sleep The wrist-mounted tri-axial GT9X ActiGraph accelerometer (Pensacola FL, USA) will also measure body position and movement, and will capture physical activity intensity and time spent sleeping. Participants will wear both monitors for eight consecutive days at each assessment time point. The timepoints that the trackers will be worn are prior to the operation (within 4 weeks), during the inpatient hospital stay following the operation, and 3 months after. Participants will then be asked to wear the trackers at 12mths and 24mths from operation. The device is removed for water-based activities (e.g. bathing) as it is not waterproof. Participants will have an initial appointment booked in person prior to their operation where the trackers will be explained and appropriately fitted, including how to troubleshoot and who to contact. This will be the only appointment face to face, otherwise trackers will be posted out. A return post envelope will be provided to return the trackers back once 8 days is complete. Accelerometer data will be analysed in RStudio. Published prediction equations will be used to determine time spent in sedentary, light, moderate and vigorous physical activity at each assessment time point. Sleep parameters will also be obtained. Patients do not get notified of activity level through these devices. A log book will be provided for participants to record any ActiGraph and/or activPAL removal times, as well as to document time of going to bed and time of waking. Trackers will be returned via mail. Clinical outcomes will be assessed according to the assessment schedule and includes: 1. Joint pain a. Numerical rating scale (0-100) b. Oxford Score (hip, knee or shoulder) 2. Self-reported physical function a. Oxford Score (hip, knee or shoulder) 3. Performance based measures a. Timed 10m walk test, 30 second chair stand test, Timed up and Go Test (TUG) 4. Quality of life a. EQ-5D-5L 5. Mental Health a. Hospital Anxiety and Depression Scale (HADS) 6. Fear of Movement a. Brief Fear of Movement Scale 7. Sleep quality a. Tracker data b. Questionnaire 8. Complications a. Revision surgery, infection, falls, readmission to hospital 9. Global change a. 7 point Likert scale 10. Discharge destination a. Usual residence or inpatient rehabilitation 11. Hospital and inpatient rehabilitation length of stay 12. Analgesia requirements
Sponsors
Deakin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All adult patients undergoing primary hip, knee or shoulder replacement who voluntarily participate in the study.
Exclusion criteria
Any patient who is not undergoing primary total hip, knee, or shoulder replacement (includes unicompartmental knee replacements, hemiarthroplasty, and revision joint replacements). Individuals deemed cognitively incapable of providing consent to participating in this study, based on the ability to consent for the operation itself, will not be included in this study. Individuals not willing to participate will be excluded from the study.
Outcome results
None listed