Efficacy and Safety of PAIR Exercise Program After Total Hip and Knee Replacement: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Quality of life questionnaire
研究概览
简要总结
Randomized controlled trial. Patients will be enrolled at the moment of the pre-surgery assessment after verifying the inclusion/exclusion criteria and signing written informed consent. After surgical treatment (THR or TKR) and subsequent rehabilitation treatment (which usually lasts 3-4 months) patients will be contacted and the persistence of inclusion/exclusion criteria verified again. For each type of surgical procedure (i.e. THR or TKR) those, with confirmed inclusion criteria will be randomly assigned to the IG or the CG. The IG will participate in a 6-month exercise program based on the PAIR exercise protocol and will receive educational sessions and material on the importance of maintaining an active life style after THR or TKR. The CG will receive only educational sessions and material on the importance of maintaining an active life style after THR or TKR. Participants of both IG and CG will be assessed at the moment of randomization (post-surgery baseline) and, subsequently, after 3 and 6 months.
详细描述
The present study is carried out within the project "Physical ActIvity after hip and knee Replacement" (PAIR) and funded within the Erasmus Plus Sport program (Grant Agreement 613008-EPP-1-2019-1-IT-SPO-SCP). It is aimed at evaluating the efficacy and safety of an exercise program specifically designed for improving physical function and QoL in people who had undergone THR or TKR for primary osteoarthritis after completing the surgical and rehabilitative treatment.
The primary objective of the study is to compare modifications of QoL measured with the Short-Form Health Survey (SF-36) induced in the intervention groups (IG) by the PAIR exercise program versus a control groups (CG) who will undergo usual care. SF-36 is one of the most widely used questionnaire to measure the health related QoL (HRQoL) in total hip and total knee arthroplasty patients.
The secondary objectives of the study are to investigate differences between IG and CG on domains which are considered to be determinants of QoL:
Hip- and knee-related impairments and functional limitations
- Harris Hip Score (HHS), American Knee Society scoring (KSS),
- Visual analog scale (VAS) to evaluate pain, High-Activity Arthroplasty Score (HAAS), ---Western Ontario and McMasters Universities Osteoarthritis
- Index (WOMAC),
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Hip Disability and Osteoarthritis Score (HOOS).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-surgery criteria
- •Signed informed consent
- •Age: 50-80 years
- •Indications: Patient with unilateral advanced Osteo-Arthrosis (OA) requiring primary THR or TKR;
- •General: American Society of Anesthesiologists (ASA) class 1 or 2
- •Resident in Bologna metropolitan area
- •Post-surgery criteria
- •Functional performance: Able to stand and walk >500 meters independently;
- •Pain: score ≤ 4 in VAS
排除标准
- •Unable/unwilling to sign the informed consent form of the study and/or willing to comply with the study requests
- •Poor knowledge of Italian language which prevents understanding of the content of the consent form and/or of instructions for assessment and/or training;
- •Severe functional limitations of other lower extremity joints besides that for which surgery is planned;
- •Impairment of communicative and/or sensory functions so severe to make impossible understanding or executing trainer's instructions (dementia, aphasia, blindness, deafness);
- •Heart failure (NYHA class >2);
- •Unstable angina;
- •Pulmonary disease requiring oxygen therapy;
- •Symptomatic peripheral arteriopathy;
- •Recent myocardial infarction or hospital admission for any other reason in the previous 6 months;
- •Symptomatic orthostatic hypotension;
- •Hypertension in poor pharmacologic control (diastolic >95 mmHg, systolic >160 mmHg);
- •Relevant neurological condition impairing motor or cognitive function;
- •Any other condition that the medical doctor (MD) considers to contraindicate the participation in an exercise program of moderate intensity;
- •Severe depression.
结局指标
主要结局
Quality of life questionnaire
时间窗: 6 months
Short-Form Health Survey (SF-36). SF-36 is one of the most widely used questionnaire to measure the health related quality of life (QoL) items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100
次要结局
- Clinical outcome(6 months)
- Clinical score(6 months)
- Lower body strength(6 months)
- Clinical Score about Hip(6 months)
- Pain score(6 months)
- Physical performance(6 months)
- Upper limb strength(6 months)
- Lower limb function(6 months)
- Range of Motion (ROM)(6 months)
- Clinical score about Hip(6 months)
- Disability(6 months)
- Balance(6 months)