Feasibility and Potential Impact of an Individualized Exercise Program Via a Telerehabilitation Device in Chronic Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- To assess functional improvement, measured by the 6-minute walk test (6MWT) after the 12 weeks ER program in people with chronic disease.
研究概览
简要总结
Exercise Rehabilitation (ER) is widely used and effective in the treatment of chronic diseases; however, patients do not adhere to ER programs. Tele-rehabilitation is effective and often used to support and improve patient adherence. Thus, the ADEPINA device could be a promising solution for the individualized management of patients by their therapists. The aim of the study will be: a) To assess functional improvement, measured by the 6-minute walk test (6MWT) after the 12 weeks ER program in people with chronic disease. Additionally, the study will assess the individualized program' adherence and his effect on patients' physical fitness and quality of life. Methods: Fifty patients will follow individualized ER sessions to their patients (with chronic diseases) using the ADEPINA device, 2 to 3 times per week for 12 weeks. At the end of the intervention, the investigator will assess patients' lower limb strength (with sit to stand test), dynamic balance (Timed up and go test), patients' adherence to the ER program by evaluating the usage time of the system by participants, the treatment credibility and participant expectations for improvement will be assessed with the French version of the Credibility and Expectancy Questionnaire. The investigator will also evaluate the patients' quality of life (using the "World Health Organization Quality of Life" (WHOQOL) scale) at the beginning and end of the intervention. Discussion: This interventional pilot study could have positive impacts for participants and explore gaps in the current literature regarding the individualized telerehabilitation program' feasibility.
详细描述
The ADEPINA project is a 12- week prospective multicentric pilot study. The project will be conducted by the HAVAE laboratory and the Limoges university will be the promoter. The study protocol is in accordance with the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) guidelines. Patients will perform ER program proposed by their professionals (as part of their routine care) through ADEPINA web platform for 12 weeks with evaluations before and after the intervention.
Participants recruitment:
The principal investigator will recruit ER therapists working in the private sector, public sector, or both. The investigator will present the study to potential participants. This study will be conducted with ER professionals (physiotherapists, kinesiologists) and their patients with chronic conditions. Volunteers who meet the inclusion criteria below and provide written consent will be included and will then receive an information notice.
Inclusion will take place within the framework of routine care for individuals with chronic diseases in rehabilitation services, hospitals, institutions, etc. The study will be offered to patients with chronic conditions who are being cared for by their therapists. Data collection will be conducted in two sessions. The period between the two sessions will be determined based on the patient's availability, not exceeding a period of 12 weeks:
- 1st session at Day 0: Conducting activities and initial evaluation at their usual care center. Therapists will perform the various planned tests and evaluations.
- 2nd session at 12 weks: This session will take place under the same conditions as the first one and without any potential health risks to the participants.
- A final follow up session will be carried out at 18 weeks. A telephone call will be made between the two sessions to check in and assist participants (both therapists and patients with chronic illnesses) in case of any issues during the study. Recruitment will be coordinated by the clinical investigation center of the University Hospital of Limoges.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for professionals of exercise rehabilitation (ER):
- •Be a physiotherapist or kinesiologist working in the public sector, private sector, or in a mixed capacity,
- •Have been graduated for at least one year,
- •Conduct ER program with chronic patients and provide written consent.
- •Inclusion Criteria for chronic patients :
- •Be 18 years of age or older,
- •Be able to walk with or without assistives devices
- •Be capable of giving informed consent,
- •Be registered with the French health social security system,
- •Be under the care of a rehabilitation exercise professional.
- •Non-inclusion criteria for patients :
- •Have an intolerance or inability to use digital tools,
- •Have a cognitive impairment,
- •Have contraindications to physical activity (unstable diabetes, unstable hypertension, unstable angina, intracardiac thrombus).
排除标准
- 未提供
结局指标
主要结局
To assess functional improvement, measured by the 6-minute walk test (6MWT) after the 12 weeks ER program in people with chronic disease.
时间窗: Day 0, Week 12, Week 18
The investigator will assess the 6-minutes walk distance change after the intervention
次要结局
- To assess the impact of the intervention onpatient's quality of life(Day 0, Week 12, Week 18)
- To evaluate the impact of the intervention on patient's lower limb strengh(Day 0, Week 12, Week 18)
- To evaluate the impact of the intervention on patient's dynamic balance(Day 0, Week 12, Week 18)
- The treatment credibility and participant expectations for improvement were assessed with the French version of the Credibility and Expectancy Questionnaire (CEQ).(Week 12, Week 18.)
- The adherence to the rehabilitation exercise program will be assessed by evaluating the system usage time by participants(Week 12, Week 18.)
研究者
Stephane Mandigout
Professor
Limoges University