Physical Activity Levels During Recovery Following Knee Arthroplasty
Identifying the Trajectory of Normal Recovery Following Knee Arthroplasty Through Physical Activity Monitoring Via Wrist-Worn Accelerometry
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study is an observational study of the physical activity levels of adults who have been diagnosed with end-stage osteoarthritis of the knee and are undergoing knee replacement surgery at the Nuffield Orthopaedic Centre, Oxford. Data regarding patient activity and functional recovery will be collected using two methods. First, data will be collected through the extraction of three-axis accelerometer data, collected via a wrist-worn (and hip-worn for a subset of patients) physical activity monitor. This data will be collected in three intervals: pre-operatively, immediately postoperatively, and at 6 months postoperatively. Secondly, data will be collected by standard clinical assessment and patient reported outcome measures. These assessments will again take place pre-operatively, at 6 weeks postoperatively, and at 6 months postoperatively. Additional data will be collected through a simple activity diary, which asks the participants to log their monitor wear-time along with the times that they took bicycle rides or extended walks.
The expected duration of patient involvement is up to a total of 8 to 8.5 weeks over the course of up to 7 months. There are no clinical visits within this protocol beyond what is already within normal patient care. Patients will be asked to post their monitor back to the research centre for data collection and data processing twice during the study period.
The aim of this study is to assess the trajectory of recovery in terms of physical activity in the post-operative knee replacement population, and subsequently to define the expected path of early recovery.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
Oxfordshire
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Oxford, Oxfordshire, Storbritannia, OX3 7LD
- Rekruttering
- Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
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Ta kontakt med:
- Gail Lang
- E-post: gail.lang@ndorms.ox.ac.uk
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Hovedetterforsker:
- Andrew J Price, DPhil, FRCS
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Underetterforsker:
- Scott R Small, MS
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Underetterforsker:
- Karen L Barker, PhD, FCSP
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Underetterforsker:
- Sara Khalid, DPhil
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with required late stage osteoarthritis, undergoing knee arthroplasty in the next 3 months.
- In Investigator's opinion, is able and willing to comply with all trial requirements.
Exclusion Criteria:
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who are enrolled in another research study involving an investigational product or methodology that could alter physical activity.
- Participants are undergoing a revision arthroplasty surgery on the operative knee
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Knee Arthroplasty Patient
Patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
|
Reconstruction of part or all of the native articulation at the knee joint via implant.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in physical activity
Tidsramme: Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively.
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The primary outcome measure will physical activity, as extracted from analysis of raw accelerometer data from the activity monitor.
Several variables will be extracted from the raw data, including average acceleration vector (Euclidean norm minus one), bouts of physical activity and percentage of active and sedentary time.
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Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Oxford Knee Score
Tidsramme: Pre-operative (baseline), 6 weeks, 6 months
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A patient reported outcome measure to assess patient benefit [Range 0 to 48, higher scores corresponding to better outcomes].
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Pre-operative (baseline), 6 weeks, 6 months
|
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Change in EQ-5D-5L
Tidsramme: Pre-operative (baseline), 6 weeks, 6 months
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A patient reported outcome measure to assess patient benefit.
As summary index score from 0 to 1 is given, where 0 is the health state equivalent to dead, 1 is a full healthy outcome, and negative indicates a health state worse than dead.
The score is derived from five sections (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression) scored 1 to 5, with higher corresponding to better outcomes.
A second visual analogue score for perceived health is reported from 0 to 100 with higher scores indicating better perceived overall health.
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Pre-operative (baseline), 6 weeks, 6 months
|
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Change in University of California, Los Angeles (UCLA) Activity Score
Tidsramme: Pre-operative (baseline), 6 weeks, 6 months
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A self-reported score to assess patient benefit and physical activity.
The score ranges from 1 to 10 where higher scores indicate greater levels of physical activity
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Pre-operative (baseline), 6 weeks, 6 months
|
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Change in International Physical Activity Questionnaire Questionnaire - Short Form
Tidsramme: Pre-operative (baseline), 6 weeks, 6 months
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A self-reported score to assess patient benefit and physical activity.
The score can be reported in one of three categories: Low, Moderate, or High physical activity.
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Pre-operative (baseline), 6 weeks, 6 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Scott R Small, MS, University of Oxford
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRAS 260855
- 19/SW/0151 (Annen identifikator: NHS Health Research Authority)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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