Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes in heart rate variability during physical tests
研究概览
简要总结
Internet-based multidisciplinary interventions will be offered to participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.
详细描述
This randomised study aimed to understand if multidisciplinary internet-based interventions performed in group and individually are applicable for participants suffering from longterm COVID-19 syndrome. Data will be collected by internet platform at Karolinska Institutet (BASS) before, after rehabilitation and at follow-up after 6 months. Both self-scored questionnaires and physical tests performed at home will be collected to understand the symptomatology, functioning and activity level. Rehabilitation during 8 weeks period will be given in groups as face-to-group, pre-recorded film sessions and by individual approach, the participants will use ExorLive app for physical activity.
The participants will be randomised for treatment and waiting lists using a website random.org. Waiting list will be offered rehabilitation interventions after at least 8 weeks period of waiting to exclude a spontaneous improvement or worsening of symptoms. To understand the impact of rehabilitation on work capacity and employment/economic supply, the data from Social Insurance databas will be obtained 2021 year before and upp to 2 years after the intervention. To understand the impact of rehabilitation on sickness-leave, the data from National Insurance Agency will be obtained for 2021 and 2022.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed COVID-19 infection
- •post-infection symptoms lasting longer than 3-6 months
- •clinically stable persons regarding symtoms or other co-morbidities
- •ability to participate in internet-based rehabilitation in group in Swedish.
排除标准
- •uncertainty regarding covid-19 infection or co-morbidities started or exacerbated during the same time
- •alcohol and drug abuse
- •untreated psychiatric and somatic co-morbidities
- •undergoing medical or psychotherapeutic treatment or rehabilitation which can interact with rehabilitation outcomes.
结局指标
主要结局
Changes in heart rate variability during physical tests
时间窗: Investigators expect normalisation at 6 months follow-up
Heart rate variability measured by puls oximeter during 2 physical tests
Change in health-related quality of life measured by Short Form-36
时间窗: Investigators expect changes at 6 months follow-up after rehabilitation
Important sub scales: vitality, general health, physical functioning, pain. Scale varies between 0 and 100 (highest)
次要结局
- Overall changed scores in validated questionnaires for fatigue, breathing, pain and sleep disorders(Investigators expect changes already at 6 months follow-up)
- Changed functioning and activity(Investigators expect normalisation at 6 months follow-up)
研究者
Indre Ljungar
associated professor in rehabilitation medicine
Danderyd Hospital