Preoperative Resistance Training in Patients Scheduled for Total Hip Arthroplasty - a Prospective Randomized Study in Patients With Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
研究概览
简要总结
Purpose:
The purpose of this study is to determine the effect of pre operative resistance training on subjects scheduled for total hip arthroplasty due to primary osteoarthritis.
Background:
Decreasing performance with age due to age related muscle loss is well known. Resistance training in elderly has shown significant effect in regaining both muscle force and function.
It has been shown that a chronic condition with limitations in function as seen in osteoarthritis of the hip decreases both muscle performance and size.
Studies of resistance training of the hip related muscle groups in the early postoperative period after total hip arthroplasty have shown significant effect on muscle force and function.
Few studies have investigated preoperative intervention, all with lighter types of training such as water pool training.
The effect of preoperative resistance training on subjects with primal osteoarthritis of the hip is yet to be described.
Study hypothesis:
Preoperative resistance training will significant improve outcomes on both primal and secondary effect parameters pre surgery and at 1 year followup.
详细描述
BACKGROUND:
Osteoarthritis of the hip is a common condition among elderly. In Denmark 8000 people underwent operation with total hip arthroplasty in 2007, due to osteoarthritis (Danish Register of hip arthroplasty 2007)).
The number of hip arthroplasties has been doubled the last decade mostly due to an increase in the age group 70-79 years (Danish Register of Hip Arthroplasty 2007). The population of elderly has been increased by to the demographic changes (Danish Statistics). A larger need for treatment could be expected in the future due to this development.
The indications of surgery is pain, reduced function and impaired quality of life related to the hip.
Osteoarthritis is divided into two groups: Primary osteoarthritis and secondary osteoarthritis. The cause of primary osteoarthritis is largely unknown. There is a certain amount of genetic predisposition (Felson et al. 1998), the condition is more common among women and the risk of osteoarthritis is larger with higher body weight (Felson et al. 1988) (Anderson et al. 1988).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for total hip arthroplasty due to primary osteoarthritis with an age of 50 years or older.
- •Patients in the intervention group must participate in 80% of the training as a minimum and more than 2 skipped sessions in a row is not allowed.
排除标准
- •Rheumatoid arthritis (RA) or other types of arthritis other than primary osteoarthritis.
- •Systemic treatment with glucocorticoid more than 3 months the last 5 years with a daily dose > 5 mg.
- •Fracture of the hip (ipsi or contralateral)
- •Other fracture of the lower extremities the last year
- •Other condition with reduced function (ex polio seq.)
- •Weight above 135 kg
结局指标
主要结局
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function - daily living)
时间窗: 12 months (endpoint - post surgery)
Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function -daily)
时间窗: 8 weeks (T1 pre surgery)
Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
Hip dysfunction and Osteoarthritis Outcome Score (HOOS function -daily living)
时间窗: 0 weeks (entrypoint =T0)
Questionnaire on Hip Dysfunktion. Rated questions on: * symptoms * stiffness * pain * function - daily living * function - sports and recreational activities. The questionnaire is validated (compared to WOMAC) in patients with oateoarthritis in the hip - both pre- and postoperative.
次要结局
- Muscle strength(12 months (post surgery))
- Body composition: Dual Energy X-ray Absorptiometry scan(DEXA scan)(0 weeks (pre surgery)
- Body composition: Dual Energy X-ray Absorptiometry scan (DEXA scan)(12 months (post surgery))
- Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms, pain, sports &recreation, hip related quality of life)(12 monts post surgery)
- Muscle Power(12 months (post surgery))
- Hip dysfunction and Osteoarthritis Outcome Score (HOOS symptoms)(0 weeks presurgery)
- Functional scores(12 months (post surgery))
- Activity score: Metabolic equivalent score (MET- score)(0 weeks (pre surgery))
- Activity score: Metabolic equivalent score (MET score)(12 months (post surgery))
研究者
Andreas Ebbe Bording Hermann
MD
University of Southern Denmark