Getting Fit for Hip and Knee Replacement: The FitJoints Multisite Randomized Controlled Trial of a Multi-modal Intervention in Frail Patients With Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 4
- 主要终点
- Between-group Difference in Physical Performance
研究概览
简要总结
Total hip or knee replacement is an important and cost-effective surgical intervention to relieve pain and improve independence and function in patients with osteoarthritis. The number of people waiting for elective surgeries has spiked in the COVID-19 pandemic. Prior to COVID-19, up to 40% of patients receiving joint replacement were frail and this number is rapidly increasing with longer wait-times and deconditioning associated with COVID-19 physical distancing. There is an urgent need to be responsive to the evolving challenges of healthcare. The proposed study is the first multi-site randomized controlled trial (RCT) to examine whether a multimodal frailty reduction intervention before surgery will improve postsurgical outcomes for this population. The COVID-19 adapted hybrid model includes a multimodal frailty intervention that may be implemented either in person or virtually and is aligned with international consensus guidelines on frailty reduction.
To utilize the FitJoints multimodal frailty intervention to build resilience of patients undergoing joint replacement surgery to improve post-operative outcomes. The investigators hypothesize the FitJoints multimodal frailty intervention, with exercise, nutrition and medication optimization, will reduce frailty and pain while improving function and quality of life.
Building upon the success of the FitJoints feasibility study (n=69) in Hamilton, Ontario, in the proposed multi-site RCT (n=192), older adults (≥60 years) undergoing hip or knee joint replacement surgery who are frail will be randomized to either the 3 to 6-months of multimodal intervention or usual care until the date of their surgery at multiple sites (Hamilton Health Sciences & St Joseph's Healthcare Hamilton, ON; London Health Science Centre, London, ON; Foothills Hospital, Calgary, AB),The FitJoints evidence-based, multimodal intervention includes a hybrid model that can be implemented either in person or virtually:
- Physiotherapist supported multi-component exercise program
- Nutrition and protein optimization including dietary counseling
- Medication review with prescribing recommendations
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-frail (score of 1 or 2) or frail (score of 3-5)
- •≥ 60 years old
- •Receiving elective unilateral total hip or knee replacement
- •Waiting time for surgery is estimated to be between 4 to 15 months
排除标准
- •Renal disorder
- •A neuromuscular disorder
- •Active cancer
- •Inflammatory arthritis
- •Unable to speak or understand English and has no caregiver for translation
- •Participating in another trial that involves protein supplementation
- •Participating in an exercise program
研究组 & 干预措施
Usual Care
Participants in the control arm will receive usual care which involves patient education that all participants who are scheduled for hip/knee replacement receive at the arthroplasty centre. This may include recommendations to attend fitness classes or discuss nutrition tips and smoking cessation initiatives with their family doctor or other healthcare provider before surgery.
FitJoints Multi-modal Intervention
干预措施: FitJoints Multi-modal Intervention (Other)
结局指标
主要结局
Between-group Difference in Physical Performance
时间窗: 3-months post-operative
Assessed by the Short Physical Performance Battery (SPPB), which consists of the following sub-components: * 4-meter walk test (walking speed): measured in seconds, scored 0 to 4 * Chair rise: the ability to rise from a chair without arms: measured in seconds, scored 0 to 4 * Standing balance test: measured in seconds, scored 0 to 4 Sub-component scores will be aggregated to produce an overall SPPB score, with higher scores indicating lower level of frailty \[range 0-12\].
次要结局
- Between-group Difference in Number of Post-operative Complications(3-months post-operative)
- Between-group Difference in Hip Function/Pain(3-months post-operative)
- Between-group Difference in Cognition(3-months post-operative)
- Between-group Difference in Physical Activities of Daily Living(3-months post-operative)
- Between-group difference in Sarcopenia(3-months post-operative)
- Between-group Difference in Nutrition(3-months post-operative)
- Between-group Difference in Frailty(3-months post-operative)
- Between-group Difference in Knee Function/Pain(3-months post-operative)
- Between-Group Difference in Instrumental Activities of Daily Living(3-months post-operative)
- Between-group Difference in Health-Related Quality of Life(3-months post-operative)
- Between-group Difference in Number of Hospitalizations(3-months post-operative)
- Between-group Difference in Number of Visits to Physicians/Healthcare Professionals(3-months post-operative)
- Between-group Difference in Number of Emergency Department Visits(3-months post-operative)
研究者
Alexandra Papaioannou
Professor, Department of Medicine
McMaster University