The Effects of Aquatic Prehabilitation in Knee OA Patients on Knee Arthroplasty Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in physical function using the eSPPB
研究概览
简要总结
With aging population, total knee arthroplasty is performed with increasing frequency. Although the surgery is successful in general, significant number of patients suffers persistent pain and disability. Traditional risk assessment tool have been focused on single organ systems. Our investigators have found that mobility, assessed by the Mobility Assessment Tool short form (MAT-sf), is a simple and accurate method to predict postoperative outcome, including length of stay, postoperative complications, and nursing home placement for older patients. Prehabilitation is the process of enhancing a person's functional capacity to withstand an incoming stressor. Although multiple studies have tested prehabilitation before joint replacement surgery, results have been mixed. The investigators hypothesize that patients with limited mobility are most likely to benefit from prehabilitation. The investigators plan to use individualized aquatic exercise as a prehabilitation tool to enhance compliance; the resistance of water strengthen muscle and increasing energy expenditure; the buoyancy of water provides environment where the joints are not weight bearing. The aims of the study are: 1) To evaluate the feasibility of prehabilitation using 6-8 weeks of aquatic exercise in 40 geriatric patients who are scheduled for total knee arthroplasty for osteoarthritis; 2) To examine the effects of 6-8 weeks of aquatic exercise on mobility, pain, stiffness, physical function, cognitive function and depression; inflammatory markers and 3) To estimate the effect of prehabilitation on postoperative outcomes. The investigators plan to enroll 40 patients age >50, who are scheduled for elective primary total knee replacement. Investigators will screen patients in the Preoperative Assessment Clinic and enroll patients who have decreased mobility, measured by MAT-sf. Patients will be randomized into either a prehabilitation group or a usual care group. All the participants will undergo extensive assessment on their pain, stiffness, and physical function, depression, balance and cognitive function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the expanded Short Physical Performance Battery (eSPPB), and Montreal Cognitive Assessment (MoCA). Serum inflammatory markers will be assessed at the baseline. The prehabilitation group will undergo 6-8 weeks of individualized aquatic exercise in a heated pool (60 min/session, 3 times per week). Aquatic equipment maybe used to challenge balance and trunk stabilization. All participants will be reassessed immediately before surgery and 4 weeks after the surgery using WOMAC, eSPPB, MoCA and MAT-sf. Serum inflammatory markers and body composition will be reassessed at the same time points. The primary outcome of interest is will be postoperative complications, length of stay, Intensive Care Unit length of stay, and institutionalization. If successful, investigators will have sound pilot data for several critical health outcomes with which to support an external proposal for a larger-scale study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Age > 50
- •Willingness to exercise in a pool 3 times a week
- •MAT-Sf score ≤ 58 for men and ≤ 50 for women
- •Participant is scheduled for primary total knee replacement surgery due to OA >4 weeks from expected BV visit
- •Not involved in any other behavioral, exercise or investigational drug intervention study
排除标准
- •Impaired cognitive function (MoCA <21)
- •Undergoing knee replacement surgery for indications other than OA
- •Undergoing bilateral knee replacements
- •Major deficits in hearing or vision
- •Currently exercising more than 3 times per week
- •Severe depression (GDS-sf ≥ 12)
- •Contraindications to the pool: open wounds/ incontinence/history of seizures in last year
研究组 & 干预措施
Standard of Care
Participant will receive standard of care and a brochure on healthy eating.
Aquatic Prehabilitation Group
The prehabilitation group will undergo 6-8 weeks of individualized aquatic exercise in a heated pool (60 min/session, 3 times per week). Aquatic equipment maybe used to challenge balance and trunk stabilization.
干预措施: Aquatic Prehab (Behavioral)
结局指标
主要结局
Change in physical function using the eSPPB
时间窗: 4-6 weeks after surgery
Change in eSPPB score from baseline (prior to surgery) to follow up (4-6 weeks after surgery)
Change in physical function using the Postural Sway Force Plate
时间窗: 4-6 weeks after surgery
Change in postural sway score from baseline (prior to surgery) to follow up (4-6 weeks after surgery)
Change in physical function using the MAT-sf
时间窗: 4-6 weeks after surgery
Change in MAT-sf score from baseline (prior to surgery) to follow up (4-6 weeks after surgery)
次要结局
未报告次要终点
