Wearable Device Guided Exercise for Patients on Total Knee Arthroplasty Wait-list
The Application of Wearable Device Guided Pre-operative Exercise Programme for Patients Awaiting Total Knee Arthroplasty: A Randomized Controlled Trial
Total knee arthroplasty (TKA) is a cost effective solution for people with end-stage knee osteoarthritis. Given Hong Kong's large senior population and age as the primary risk factor for osteoarthritis, waiting times for total knee arthroplasty can reach 30 months. To manage this long wait list, patients would be enrolled to a structured exercise program with group and home based exercise. Currently limited options are available for home based exercise adherence monitoring for TKA patients on the wait-list. This study will assess the effect of wearable device with smartphone application to guide home based exercise among these wait-list patients. The main hypothesis is that the use of wearable device will decrease patient's pain level and improve their physical activity level.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
All participants will consent that their anonymized data will be collected and used for scientific publications in accordance to the declaration of Helsinki. Patients on the wait-list for primary TKA at Prince of Wales Hospital in Hong Kong would be recruited and randomized to either wearable device or control group with measurements done at baseline, six weeks and six months post intervention. Control group received standard training intervention and follow up schedules, while the wearable device group would receive the wearable device and associated smartphone application along with familiarization training over the first six weeks of training.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Michael TY Ong, Professor
- Telefonnummer: (852) 3505-2723
- E-mail: michael.ong@cuhk.edu.hk
Undersøgelse Kontakt Backup
- Navn: Tianzhi Jiang, M.Sc
- E-mail: TJjiang@cuhk.edu.hk
Studiesteder
-
-
New Territories
-
Shatin, New Territories, Hong Kong
- Prince of Wales Hospital
-
Kontakt:
- Tianzhi Jiang, M.Sc
- E-mail: TJjiang@cuhk.edu.hk
-
Kontakt:
- Dhananjaya Sutanto, Ph.D.
- E-mail: dhananjayasutanto@cuhk.edu.hk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- end-stage knee osteoarthritis according to European Alliance of Associations for Rheumatology
- Radiographic evidence of joint damage
- Significant functional limitations
- Severe knee pain
Exclusion Criteria:
- Had undergone bilateral TKA,
- exercise contraindication
- terminal illness
- chronic immobility
- acute myocardial infraction within previous six weeks
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control
Participants received standardized group and home based intervention with similar measurement time points and exercise prescription as the intervention |
Participants received home based exercise prescription only. |
|
Eksperimentel: Wearable
Participants received wearable device with complementary smartphone application for exercise monitoring |
Participants received the same group and home based exercise prescription, with the same measurement timeline as control group. Participants received wearable device with application for smartphone for home exercise monitoring and familiarization during group training sessions |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee Injury Osteoarthritis Outcome Score (KOOS)
Tidsramme: baseline, 6 weeks and 6 months
|
10 minute self completed questionnaire measuring five sub-scales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). Each sub-scale scored from 0 to 100, with 100 being no complaints. |
baseline, 6 weeks and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee Flexion during walking
Tidsramme: baseline, 6 weeks and 6 months
|
Patients walk and have their knee flexion measured using optical motion capture, outcome in degrees. |
baseline, 6 weeks and 6 months
|
|
Hip Flexion during walking
Tidsramme: baseline, 6 weeks and 6 months
|
Patients walk and have their hip flexion measured using optical motion capture, outcome in degrees. |
baseline, 6 weeks and 6 months
|
|
Knee Flexion during sit-to-stand
Tidsramme: baseline, 6 weeks and 6 months
|
Patients does sit-to-stand and have their knee flexion measured using optical motion capture, outcome in degrees. |
baseline, 6 weeks and 6 months
|
|
Hip Flexion during sit-to-stand
Tidsramme: baseline, 6 weeks and 6 months
|
Patients does sit-to-stand and have their hip flexion measured using optical motion capture, outcome in degrees. |
baseline, 6 weeks and 6 months
|
|
30 seconds chair to stand test
Tidsramme: baseline, 6 weeks and 6 months
|
Participant sat on on a chair then execute repetitive sit-to-stand movement as much as possible within 30 seconds, outcome in number of repetitions completed. |
baseline, 6 weeks and 6 months
|
|
Functional Reach Test
Tidsramme: baseline, 6 weeks and 6 months
|
Participant stand with their feet together and legs straight, then try to reach forward as far as possible, outcome in reach distance (centimeter). |
baseline, 6 weeks and 6 months
|
|
Timed Up and Go Test
Tidsramme: baseline, 6 weeks and 6 months
|
Participant started in seated position, on instruction would stand up, walk forward for three meters, return back to the chair and sit down. Outcome in time (seconds) needed to complete. |
baseline, 6 weeks and 6 months
|
|
Knee Society Score (KSS)
Tidsramme: baseline, 6 weeks and 6 months
|
Physician assessed questionnaire measuring patient pain, range of motion, stability, and joint alignment, scoring between 0 to 100, with 100 being perfect score. |
baseline, 6 weeks and 6 months
|
|
Knee Society Functional Score
Tidsramme: baseline, 6 weeks and 6 months
|
Patient self-assessment questionnaire measuring their ability to execute physical activities, scoring between 0 to 100, with 100 being perfect score. |
baseline, 6 weeks and 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026.428
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
only anonymized data can be shared with interested parties as this is clinically sensitive data
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .