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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Michael TY Ong, Professor
- 전화번호: (852) 3505-2723
- 이메일: michael.ong@cuhk.edu.hk
연구 연락처 백업
- 이름: Tianzhi Jiang, M.Sc
- 이메일: TJjiang@cuhk.edu.hk
연구 장소
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New Territories
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Shatin, New Territories, 홍콩
- Prince of Wales Hospital
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연락하다:
- Tianzhi Jiang, M.Sc
- 이메일: TJjiang@cuhk.edu.hk
-
연락하다:
- Dhananjaya Sutanto, Ph.D.
- 이메일: dhananjayasutanto@cuhk.edu.hk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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. |
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실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knee Injury Osteoarthritis Outcome Score (KOOS)
기간: baseline, 6 weeks and 6 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knee Flexion during walking
기간: baseline, 6 weeks and 6 months
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Patients walk and have their knee flexion measured using optical motion capture, outcome in degrees. |
baseline, 6 weeks and 6 months
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Hip Flexion during walking
기간: baseline, 6 weeks and 6 months
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Patients walk and have their hip flexion measured using optical motion capture, outcome in degrees. |
baseline, 6 weeks and 6 months
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Knee Flexion during sit-to-stand
기간: baseline, 6 weeks and 6 months
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Patients does sit-to-stand and have their knee flexion measured using optical motion capture, outcome in degrees. |
baseline, 6 weeks and 6 months
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Hip Flexion during sit-to-stand
기간: 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
기간: baseline, 6 weeks and 6 months
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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
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Functional Reach Test
기간: 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
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Timed Up and Go Test
기간: 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
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Knee Society Score (KSS)
기간: baseline, 6 weeks and 6 months
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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
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Knee Society Functional Score
기간: baseline, 6 weeks and 6 months
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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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026.428
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
only anonymized data can be shared with interested parties as this is clinically sensitive data
약물 및 장치 정보, 연구 문서
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