Effect of Nordic Walking and Inspiratory Muscle Training to Promote Cardiopulmonary Function in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quadriceps strength
研究概览
简要总结
The aim of this randomized controlled trial is to evaluate the effect of Nordic walking and inspiratory muscle training (IMT) on cardiopulmonary function in patients with knee osteoarthritis (OA). Mild-to-moderate knee OA patients are randomly allocated into Experimental group (Nordic walking plus routine management) or Control group (Routine management). While End-stage knee OA patients are randomly allocated into Experimental group (IMT plus pre-operative rehabilitation exercise) or Control group (Pre-operative rehabilitation exercise). Participants are invited to undergo two assessments, including baseline assessment, post-intervention assessment. Researchers will compare two groups to see if the cardiopulmonary function can be improved after intervention.
详细描述
This study recruits patients with different stages and assigns them into different interventions and comparing the effect with those not receiving intervention. It will provide the evidence in terms of the exercise that can promote cardiopulmonary function and at the same time reduce pain and disability for patients with different stages of knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator and outcomes assessor won't know the allocation of participants.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pain on the most days in one or both knees in the past month;
- •difficulty with at least one of daily living activities measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale;
- •radiographic evidence of knee OA in the tibial-femoral compartment (Kellgren and Lawrence grade, K/L ≥1, K/L 1-3 regarded as mild-to-moderate knee OA, others waiting for knee arthroplasty regarded as end-stage knee OA);
- •with normal or corrected visual and auditory function and walking unaided;
- •primary knee OA for more than 6 months, be stable on medication for at least 3 weeks.
排除标准
- •knee surgery priorly;
- •have steroid injection in previous three weeks;
- •have inflammatory arthritis (e.g., rheumatoid); or unstable angina, or myocardial infarction, or cardiac surgery; or stroke; or treatment with steroids, hormones, or cancer chemotherapy; or pulmonary diseases (force vital capacity<80% of predicted and/or forced expiratory volume at first second<70% of predicted); or a history of exercise-induced asthma;
- •unable to understand the procedure and potential risks of the study;
- •medically unstable that indicate unsafe to participate in exercise test
结局指标
主要结局
Quadriceps strength
时间窗: Baseline, up to 8 weeks
Cardiopulmonary function
Grip strength
时间窗: Baseline, up to 8 weeks
Cardiopulmonary function
30-sec chair stand test
时间窗: Baseline, up to 8 weeks
Cardiopulmonary function
The six-minute walk test
时间窗: Baseline, up to 8 weeks
Cardiopulmonary function
Timed up-and-go test
时间窗: Baseline, up to 8 weeks
Cardiopulmonary function
次要结局
- Forced expiratory volume at first second(Baseline, up to 8 weeks)
- Inspiratory muscle strength(Baseline, up to 8 weeks)
- Medical Research Council scale(Baseline, up to 8 weeks)
- Pittsburgh Sleep Quality Index(Baseline, up to 8 weeks)
- Western Ontario and McMaster Universities Osteoarthritis Index(Baseline, up to 8 weeks)
- Forced vital capacity(Baseline, up to 8 weeks)
- Quadriceps muscle oxygenation(Baseline, up to 8 weeks)
- Multidimensional Fatigue Inventory(Baseline, up to 8 weeks)
- Actigraph(Baseline, up to 8 weeks)
- Maximum voluntary ventilation(Baseline, up to 8 weeks)
- Inspiratory muscle endurance(Baseline, up to 8 weeks)
- Physical Activity Scales for the Elderly(Baseline, up to 8 weeks)
- 12-Item Short Form Health Survey(Baseline, up to 8 weeks)