Impact of Motivational Feedback on Levels of Physical Activity and Quality of Life by Activity Monitoring Following Knee Arthroplasty Surgery - Randomized Controlled Trial Nested in a Prospective Cohort (KneeActivity)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 5
- 主要终点
- Between-group change score of total daily PA (accelerometer counts)
研究概览
简要总结
The goal of this randomized controlled trial (RCT) nested in a prospective cohort study is to investigate whether physical activity (PA) following total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA) can be optimized by the use of an activity tracking device including motivational feedback in comparison with activity tracking without feedback. Furthermore, the project will investigate the predictive value of PA level prior to TKA/UKA for the length of stay, return to work, and quality of life.
The main hypothese of the study are:
RCT study:
- Using an activity tracking device, including motivational feed-back on PA show a superior short-term effect on increased PA (Total counts; primary outcome measure), physical functioning, return to work, and quality of life in comparison with no motivational feed-back from the activity tracker, defined as 'care as usual', in TKA and UKA patients
- Using an activity tracking device, including motivational feedback, will have a superior effect on step counts, activity types and pain compared to the standard care, in TKA and UKA patients
Prospective cohort:
- PA prior to TKA or UKA can work as a predictive measure for function and quality of life following surgery
- PA prior to TKA or UKA can work as a predictive measure for the length of hospital stay and return to work
Patients will be randomized to activity tracking and motivational feed-back by gamification for patient self-mobilization (Intervention-group) or 'care-as-usual' including activity tracking without motivational feed-back (Control-group). Patients not eligible and/or willing to participate in the RCT study, will be offered to participate in a prospective non-interventional cohort study.
详细描述
Background:
Worldwide over a million patients receive a TKA or UKA each year and in Denmark more than 10,000 TKA and UKA's are performed annually, and the lifetime risk of symptomatic osteoarthritis (OA) of the knees are 45%. Despite being considered a successful intervention, 15-25% of patients following TKA are not satisfied with their output, which to some degree may be associated with reduced daily physical activity (PA). Few scientific studies have examined how daily PA is affected by TKA and how it might affect rehabilitation. It is unknown if a focus on increased PA in everyday life after return from hospital might improve rehabilitation and patient satisfaction. The current study addresses this 'gap' in science with high-level clinical evidence, to investigate if a novel technology on motivational feed-back regarding PA can be introduced to assist patients with a better rehabilitation following TKA or UKA.
Aim:
The aim of this randomized controlled trial (RCT) nested in a prospective cohort is to investigate whether PA following TKA or UKA can be optimized by the use of an activity tracking device including motivational feedback in comparison with activity tracking without feedback. Furthermore, a prospective cohort will investigate the predictive value of PA level prior to TKA/UKA for the post-surgical length of stay, return to work, and quality of life.
Trial design overview:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Data will be analyzed by the PhD student blinded towards group allocation.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 40-85 years
- •patients scheduled for primary TKA or UKA
- •understanding both verbal and written Danish language.
排除标准
- •Difficulty adhering to the study protocol
- •Refusal of standard care
- •Known- or newly diagnosed malignancy or palliative care
- •Participation in an interventional clinical trial during the last 3 months potentially interacting with the aims of the current study.
- •Do not own a smartphone
研究组 & 干预措施
Intervention
Activity tracking and motivational feed-back by gamification.
干预措施: SENS Motion + Motivational Feedback (Device)
Care as usual
Activity tracking without motivational feed-back
结局指标
主要结局
Between-group change score of total daily PA (accelerometer counts)
时间窗: Baseline and 12 weeks
PA will be evaluated by SENS Motion as described above. The primary outcome measure is the between-group change score of total daily PA (accelerometer counts) from baseline to 12 weeks following discharge. Accelerometer counts per day is a cumulative and validated variable based on raw accelerometer data in 3 planes and is a proxy for total daily PA
次要结局
- Physical active minuts (Between-group change)(Baseline and 12 weeks)
- Patient satisfaction and patient reported outcome measures (Between-group change)(Baseline, 12 weeks and 12 months)
- Quality of Life (Between-group change)(Baseline, 12 weeks and 12 months)
- Return to work in day-surgery (Between-group change)(12 weeks, 12 months)
- Global Perceived Effect (GPE) (Between-group change)(12 weeks, 12 months)
- Physical activity (Between-group change)(Baseline, 12 weeks and 12 months)
研究者
Anders Holsgaard Larsen
Professor, PhD
Odense University Hospital