The Effect of 12-Week-Virtual Reality Based Tele-Exercises on Exercise Capacity in Cystic Fibrosis Patients: A Randomized Controlled, Single (Assessor)-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- 6-minute walk distance
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of a-12-week virtual reality exercise program, applied as tele-exercise, on the exercise capacity of children with cystic fibrosis, whose physical activity level is further restricted during the pandemic. The main questions it aims to answer are:
Does aerobic tele-exercise increase functional capacity in cystic fibrosis patients? Will there be a difference in treatment outcomes between the virtual reality group and the online exercise group?
Participants will be randomized into two groups; virtual reality group and online group. Physical activity will be provided to the virtual reality group in the form of team activities in a virtual environment, and the other group will be provided online exercises at their home. For this purpose, virtual reality headsets will be provided to patients to give the impression of a natural, immersive environment and realistic experience.
Researchers will compare exercise compliance and functional capacity between the virtual reality group and the online group.
详细描述
This project aims to investigate the effects of a-12-week virtual reality exercise program, applied as tele-exercise, on the exercise capacity of children with cystic fibrosis, whose physical activity level is further restricted during the pandemic. The originality of this study is that it would be the first study in which immersive virtual reality exercises will be performed through tele-exercise in cystic fibrosis.
Prognosis in cystic fibrosis is related to respiratory capacity and physical activity level. Aerobic exercise positively affects lung functions; increases aerobic capacity, survival and quality of life in cystic fibrosis.
Face-to-face activities in children with cystic fibrosis increase the risk of cross-contamination and lung infection. Remote exercises will be more cost effective in terms of transportation/time loss as well as reduction of infection risk.
Virtual reality exercises based on video game activities provide a good alternative, especially for motivating and increasing the adaptation of young individuals to rehabilitation. This project plans to investigate the hypothesis that exercise capacities would increase with virtual reality exercises performed in groups that help socialization, without the risk of hospital infection.
Patients will be randomized into two groups. Physical activity will be provided to the virtual reality group in the form of team activities in a virtual environment. For this purpose, virtual reality headsets will be provided to patients to give the impression of a natural, immersive environment and realistic experience. The activities will be carried out in groups of 4-6 children with cystic fibrosis, accompanied by a physiotherapist, for 12 weeks, 3 days a week, between 30-45 minutes in both 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
- Single (Outcomes Assessor)
盲法说明
In the study, outcomes assessor will not know which group the children belong to.
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 and 16 years,
- •Clinical stability without disease exacerbations in the 4 weeks prior to their enrollment into the study
- •Having access to internet and parental or legal caregiver consent
排除标准
- •Children with a pulmonary exacerbation in the previous 4 weeks,
- •Active pulmonary infection,
- •Evidence of pulmonary hypertension
- •Any cardiological, musculoskeletal, neurological or cognitive comorbidities that prevent exercise participation,
- •Behavioral ot intellectual difficulties that prevent participation in assessments or exercises provided remotely
- •Children with oxygen supplementation (daily continuous use or > 2 L/min at night)
- •Lung transplant candidates
结局指标
主要结局
6-minute walk distance
时间窗: 12 weeks
6-minute walk distance is a valid and reproducible test in the assessment of functional capacity in children and adolescent with cystic fibrosis. The children were asked to walk in a 30-meter corridor as far as possible in 6 minutes. Distance covered in 6 minutes was recorded as the primary outcome measure.
次要结局
- Hand grip strength(12 weeks)
- Cystic Fibrosis Questionnaire-Revised(12 weeks)
- Body weight(12 weeks)
- Quadriceps strength(12 weeks)
- Deltoid strength(12 weeks)
- Forced expiratory volume(12 weeks)
- The Physical Activity Enjoyment Scale(up to 12 weeks)
- Body height(12 weeks)
- Forced vital capacity(12 weeks)
- Forced expiratory volume/Forced vital capacity(12 weeks)
- The Physical Activity Questionnaire(12 weeks)
- System Usability Scale(up to 12 weeks)
- Accelerometer(12 weeks)
- Body mass index(12 weeks)
研究者
Ozden Ozyemisci Taskiran
Clinical Professor
Koç University