Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Analyze the improvement of the forced vital capacity (FVC).
研究概览
简要总结
The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy.
详细描述
It will be done 4 times a week for a period of 5 weeks, for a duration of 55-60 minutes (20 sessions), with an intensity adapted to the characteristics of each participant. An intervention program will be used based on respiratory muscle training exercises, upper limb strength work, yoga, diaphragmatic awareness exercises, always trying to do them through the use of games, and even try to include exercises that use motor imagery.
It is advisable during intervention program to have a playful environment stimulated for the children, and that the intervention program is carried out and stimulated through videos and therapeutic teaching to the caregivers in the first evaluation session, as well as with a weekly follow-up using WhatsApp as forms of communication, or a telephone call to ensure correct follow-up of the intervention program.
It is essential that to carry out the intervention, videos obtained from YouTube, own videos prepared to explain the exercises in a playful way applied to children, and even other applications such as Spotify to work with music, will be used, being offered in case of Zoom calls may be necessary to help optimally resolve doubts that arise when carrying out the program by video call.
At the end of the respiratory digital physiotherapy program, variables will be evaluated by the principal examiner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Duchenne muscular dystrophy and patients with Becker muscular dystrophy will be chosen.
- •Aged between 5 and 20 years.
- •Child who could walk and follow the intervention program, and were diagnosed according to the International Classification of Diseases, 10 Revision. code (G71-01); and who had an NSSA score greater than 20.
排除标准
- •Patients who present associated heart disease.
- •Patients who presentor fractures, a heart rate greater than 120 beats per minute, or an oxygen saturation less than 89% will be excluded.
- •Participants who do not have the capacity to have internet at home to perform the intervention, as well as all patients whose caregivers did not agree to sign the informed consent.
结局指标
主要结局
Analyze the improvement of the forced vital capacity (FVC).
时间窗: Baseline, up to 5 weeks.
Forced vital capacity is a respiratory parameter which is obtained from spirometry and which provides objective, valid information. It will be performed using spirometry before and after the digital respiratory intervention program. The spirometer that will be used is the "EasyOne Air Spirometer that complies with ISO 26782 standards, following the national spirometric recommendations of the ATS/ERS 2019.
次要结局
- Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination.(Baseline, up to 5 weeks.)
- Examine changes in forced expiratory pressure(Baseline, up to 5 weeks.)
- Perform an anthropometric study of the patient's characteristics, taking into account age.(Baseline, up to 5 weeks.)
- Check if there are changes in the sniff nasal inspiratory pressure (SNIP)(Baseline, up to 5 weeks.)
- Perform an anthropometric study of the patient's characteristics, taking into account height.(Baseline, up to 5 weeks.)
- Perform an anthropometric study of the patient's characteristics, taking into account sex.(Baseline, up to 5 weeks.)
- Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP).(Baseline, up to 5 weeks.)
- Evaluate the fatigue in patients using an EPInfant test.(Baseline, up to 5 weeks.)
- Evaluate the quality of life of patients using a scale called "Kindscreen-52".(Baseline, up to 5 weeks.)
- North Star Ambulatory Assessment o NSAA(Baseline, up to 5 weeks.)
研究者
Rocío Martín Valero
Principal Investigator
University of Malaga