Effect of Physical Surroundings on Effects From Exercise as Treatment for Hip or Knee Pain: A Double-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Patients' Global Perceived Effect
研究概览
简要总结
The study is designed to investigate the effect of physical surroundings on the effect of exercise therapy for knee and hip pain.
详细描述
Context effect have been shown to be influential in health-care settings, such as hospitals. This study investigates if context effects can be caused by the physical surroundings of exercise.
The study is designed as a double-blind randomized controlled clinical trial. Patients with knee and/or hip pain with a duration of a least 3 months are included in the trial and randomly assigned to 3 groups.
- Exercise in pre-existing, standard room
- Exercise in contextually enhanced room.
- Waiting list.
The intervention consists markedly different between the two exercise rooms. The physical surroundings are described by factors such as acoustics, light source and intensity, decorations and air quality.
The exercise program applied is based on a previously investigated neuromuscular exercise program, NEMEX. The same program is performed in both exercise rooms. Consequently, only the physical surroundings differ between intervention groups.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 35 years or older
- •Self-report of knee and/or hip pain within the last 3 months.
- •Willing and able to attend exercise therapy at the University of Southern Denmark, Odense M twice weekly.
排除标准
- •Co-morbidities or contraindication prohibiting to participation in exercise therapy.
- •Unable to fill-out questionnaires, or to speak, read or understand Danish.
- •Already participating in exercise therapy*, having had surgery to the hip/knee within the last 3 months or on waiting list for joint surgery within the coming 6 months. (*defined as supervised exercise program by physiotherapist, systematic strength training etc. with duration of 6 weeks or more)
结局指标
主要结局
Patients' Global Perceived Effect
时间窗: 8 weeks
Patients indicate their perception of the global effect of the intervention on a 7 point likert scale ranging from "substantially worse" to "no change" to "substantially improved". The scale is balanced around the 'no change' response with 3 steps in each direction, respectively deterioration or improvement.
次要结局
- Change from baseline in Arthritis Self-Efficacy Scale(baseline, 4 weeks, 8 weeks.)
- Patient satisfaction with physical surroundings(8 weeks)
- Change from baseline in KOOS (The Knee injury and Osteoarthritis Outcome Score) or HOOS (The Hip Dysfunction and Osteoarthritis Score), respectively(Baseline, 4 weeks, 8 weeks)
- Change from baseline in The 36-item Short-Form Health Survey (SF-36)(Baseline, 4 weeks, 8 weeks)
研究者
Louise Fleng Sandal
MSc, Ph.d student
University of Southern Denmark