The Added Value of Multimodal Biopsychosocial Teleprehabilitation in People Undergoing Total Knee Arthroplasty: a Pilot/Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Participation rate
研究概览
简要总结
Knee replacement surgeries are one of the most frequently performed elective surgeries, with approximately 29,000 such procedures carried out annually in Belgium. Although these surgeries have been increasingly refined over the years, leading to better surgical outcomes, there is still room for improvement in terms of pre-surgical biopsychosocial patient preparation. Such preparation aims to optimally inform patients before their surgery and to start preparing them for rehabilitation and resumption of activities after surgery. Therefore, we aim to assess the added value and feasibility of prehabilitation within the knee replacement care pathway.
The primary objective is to investigate the feasibility, acceptability and safety of multimodal biopsychosocial teleprehabilitation (BPS-teleprehab) for people undergoing total knee arthroplasty (TKA).
The secondary objective is to explore the effect of BPS-teleprehab versus best-evidence preoperative advice for people undergoing TKA on activity outcomes, functioning, pain, symptoms of central sensitization, quality of life, cognitive-emotional factors, joint awareness, satisfaction with the surgery, healthcare and medication use and productivity loss.
The tertiary objective is to explore baseline associations between the collected outcome measures, demographics and medical data in people scheduled for TKA.
Furthermore, this pilot trial will inform potential protocol modifications in prepara- tion of an eventual fully powered randomized controlled trial to investigate the ef- fectiveness of BPS-teleprehab in people undergoing TKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People scheduled for elective primary TKA at one of the participating hospitals;
- •Being over 18 years old;
- •Dutch speaking/reading
排除标准
- •Doing activities that make them feel out of breath for 300 minutes or more per week on average;
- •Orthopedic, neurological, cardiovascular or any other condition/comorbidity that leads to an overall contraindication for moderate physical activity;
- •Cognitive impairment (≥11 on 6-item Cognitive Impairment Test and/or unable to understand the study instructions);
- •Presence of uncontrolled inflammatory arthritides (e.g., rheumatoid arthritis, gout);
- •Uncontrolled psychiatric disorders;
- •Active cancer and/or active cancer treatment ((hormonal) maintenance therapy is allowed);
- •People undergoing emergency (non-elective) TKA.
结局指标
主要结局
Participation rate
时间窗: assessed throughout the duration of the participant recruitment for the trial
This will be calculated as the ratio of the number of patients participating in the study to the number of patients eligible for study participation.
Patient satisfaction with the intervention (feeling of contentment with the intervention)
时间窗: at 6 weeks post-surgery
This will be assessed by qualitative in-depth interviews with the study participants.
Compliance with the one-on-one BPS-teleprehab sessions
时间窗: Within one week after intervention completion
The compliance rate for the teleprehabilitation sessions will be calculated as the ratio of the number of followed treatment sessions versus the number of planned treatment sessions.
Feasibility of BPS-teleprehab in the clinical setting
时间窗: through study completion
The feasibility of BPS-teleprehab in the clinical setting will be investigated by qualitative focus group discussions with healthcare providers involved in the care trajectory of people undergoing total knee arthroplasty.
Incidence of treatment-emergent adverse events (safety and tolerability)
时间窗: At the end of each intervention session + throughout the duration of the study
After each intervention session, patients of the experimental group will be asked whether they experienced any side effects or unexpected events associated with the intervention. Furthermore, participants are encouraged to report any side effects/unexpected events to the study team at any time throughout the study.
Compliance with home exercises
时间窗: Within one week after intervention completion
Patients will be asked to log their home exercise sessions in an intervention log book. The compliance with these home exercise sessions is calculated as the ratio between the number of sessions performed and the number of sessions prescribed.
次要结局
- Knee-specific pain and functioning(Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.)
- Symptoms of central sensitization(Baseline, 6 months, 12 months post-surgery.)
- Pain catastrophizing(Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.)
- Fear of movement and/or (re)injury(Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.)
- Perceived Self-efficacy to exercise(Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.)
- Total knee arthroplasty expectations(Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery.)
- Physical activity (patient-reported outcome)(Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Actigraphy data will be registered for 1 week prior to the assessment moment for the remaining outcomes.)
- Health-related quality of life(Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.)
- Physical activity (objective measure)(Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Actigraphy data will be registered for 1 week prior to the assessment moment for the remaining outcomes.)
- Joint awareness of the replaced joint(Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.)
- Satisfaction with surgery(Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.)
- Overall change following knee replacement surgery(Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.)
- Healthcare and medication use(Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.)
- Productivity loss/return to work(6 months and 12 months post-surgery.)