The Effect of Total Knee Arthroplasty on Habitual Physical Activity, Sedentary Behaviour and Health Outcomes in Patients With Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Habitual physical activity level
研究概览
简要总结
The purpose of this study is to determine whether habitual physical activity and sedentary behaviour improve six weeks and between three to six months after total knee replacement surgery in people with osteoarthritis.
详细描述
The aims of this study are to
- describe habitual physical activity and sedentary behaviour patterns in knee osteoarthritis patients who are scheduled for total knee arthroplasty,
- investigate the effects of unilateral primary total knee arthroplasty on objectively and subjectively measured physical activity, sedentary behaviour and health outcomes of knee OA patients and
- compare subjective measures of functional ability and sedentary behaviour (questionnaires) with objective measures of habitual physical activity and sedentary behaviour (accelerometry) both before and after total knee arthroplasty.
Study design:
This a longitudinal follow-up study of a cohort of participants who have been diagnosed with knee osteoarthritis and who will all be undergoing total knee arthroplasty. After enrolment into the study, baseline assessments will be done prior to total knee arthroplasty. After total knee arthroplasty, participants will be followed-up and the same assessments done at baseline will also be done at 6 weeks, and 3 to 6 months post-operatively. Habitual physical activity and sedentary behaviour will be measured using accelerometry (Actigraph GTX3+ and ActivPal monitors) at the specific time points.The ActiGraph will be worn by participants for 24 hours/day for seven days at each of the assessment time points. It will be attached to an elastic nylon strap which the participants can wear as a belt around the waist on the side of right/left hip (depending on which knee is being operated on). Thus, the ActiGraph will be worn on the side of left hip if the total knee arthroplasty is on the left knee and vice versa. Participants will be asked to remove the ActiGraph when showering, bathing or swimming. After seven days of accelerometer wear, the accelerometers will be collected at the next possible visit to the hospital or arrangement will be made for collection from participants at a location most convenient to them. An ActivPAL will be taped to the thigh of the patient with waterproof taping and the patient will be asked to keep the ActivPAL on for the same amount of time as the ActiGraph. The ActivPAL can be covered with waterproof taping therefore, there will be no need to remove the ActivPAL when showering, bathing or swimming. The ActivPAL will be collected at the same time as the ActiGraph. In addition, general health, functional ability, generic quality of life and sleep and pain questionnaires will be conducted at each time point on each participant.
Study Site:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of knee osteoarthritis
- •Kellgren and Lawrence grade 4 severity of knee osteoarthritis
- •refractory to analgesics for at least six months
- •undergoing primary or first-time single total knee arthroplasty
- •are ambulant with or without assistive devices
排除标准
- •use assistive ambulatory devices for mobility problems other than knee osteoarthritis
- •scheduled for bilateral knee arthroplasty, a second knee arthroplasty or revision
- •scheduled for total hip replacement
- •co-morbidities or medical conditions that affect physical activity such as congestive heart failure, stroke and other neurological problems, chronic obstructive pulmonary disease, gout and/or sepsis
- •rheumatoid arthritis
- •undergoing another surgery following the knee arthroplasty
- •non-ambulant or wheel chair-bound
结局指标
主要结局
Habitual physical activity level
时间窗: Between three and six months post-op
Measured using the ActiGraph accelerometer
Time spent in sedentary behaviour
时间窗: Between three and six months post-op
Measured using the activPAL accelerometer
次要结局
- Pain(Baseline, 6 weeks post-op, between 3 and 6 months post-op)
- Knee osteoarthritis-specific quality of life(Baseline, 6 weeks post-op, between 3 and 6 months post-op)
- Activity(Baseline, 6 weeks post-op, between 3 and 6 months post-op)
- Total summed score of pain, activity, sport and recreation function and knee-related quality of life.(Baseline, 6 weeks post-op, between 3 and 6 months post-op)
- Score of pain and physical disability(Baseline, 6 weeks post-op, between 3 and 6 months post-op)
- Patient functional score(Baseline, 6 weeks post-op, between 3 and 6 months post-op)
- Knee functional score(Baseline, 6 weeks post-op, between 3 and 6 months post-op)
- Sleep quality(Baseline, 6 weeks post-op, between 3 and 6 months post-op)
研究者
Rebecca Meiring
Dr
University of Witwatersrand, South Africa