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- Kjellberg, A, et al.
(författare)
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Hyperbaric oxygen for treatment of long COVID-19 syndrome (HOT-LoCO): protocol for a randomised, placebo-controlled, double-blind, phase II clinical trial
- 2022
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Ingår i: BMJ open. - : BMJ. - 2044-6055. ; 12:11, s. e061870-
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Tidskriftsartikel (refereegranskat)abstract
- Long COVID-19, where symptoms persist 12 weeks after the initial SARS-CoV-2-infection, is a substantial problem for individuals and society in the surge of the pandemic. Common symptoms are fatigue, postexertional malaise and cognitive dysfunction. There is currently no effective treatment and the underlying mechanisms are unknown, although several hypotheses exist, with chronic inflammation as a common denominator. In prospective studies, hyperbaric oxygen therapy (HBOT) has been suggested to be effective for the treatment of similar syndromes such as chronic fatigue syndrome and fibromyalgia. A case series has suggested positive effects of HBOT in long COVID-19. This randomised, placebo-controlled clinical trial will explore HBOT as a potential treatment for long COVID-19. The primary objective is to evaluate if HBOT improves health-related quality of life (HRQoL) for patients with long COVID-19 compared with placebo/sham. The main secondary objective is to evaluate whether HBOT improves endothelial function, objective physical performance and short-term HRQoL.Methods and analysisA randomised, placebo-controlled, double-blind, phase II clinical trial in 80 previously healthy subjects debilitated due to long COVID-19, with low HRQoL. Clinical data, HRQoL questionnaires, blood samples, objective tests and activity metre data will be collected at baseline. Subjects will be randomised to a maximum of 10 treatments with hyperbaric oxygen or sham treatment over 6 weeks. Assessments for safety and efficacy will be performed at 6, 13, 26 and 52 weeks, with the primary endpoint (physical domains in RAND 36-Item Health Survey) and main secondary endpoints defined at 13 weeks after baseline. Data will be reviewed by an independent data safety monitoring board.Ethics and disseminationThe trial is approved by the Swedish National Institutional Review Board (2021–02634) and the Swedish Medical Products Agency (5.1-2020-36673). Positive, negative and inconclusive results will be published in peer-reviewed scientific journals with open access.Trial registration numberNCT04842448.
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- Rydwik, E., et al.
(författare)
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ReCOV : recovery and rehabilitation during and after COVID-19-a study protocol of a longitudinal observational study on patients, next of kin and health care staff
- 2021
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Ingår i: BMC Sports Science, Medicine and Rehabilitation. - : Springer Science and Business Media LLC. - 2052-1847. ; 13:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: The knowledge of the long-term consequences of covid-19 is limited. In patients, symptoms such as fatigue, decreased physical, psychological, and cognitive function, and nutritional problems have been reported. How the disease has affected next of kin, as well as staff involved in the care of patients with covid-19, is also largely unknown. The overall aim of this study is therefore three-fold: (1) to describe and evaluate predictors of patient recovery, the type of rehabilitation received and patients’ experiences of specialized rehabilitation following COVID-19 infection; (2) to study how next of kin experienced the hospital care of their relative and their experiences of the psychosocial support they received as well as their psychological wellbeing; (3) to describe experiences of caring for patients with COVID-19 and evaluate psychological wellbeing, coping mechanisms and predictors for development of psychological distress over time in health care staff.Methods: This observational longitudinal study consists of three cohorts; patients, next of kin, and health care staff. The assessments for the patients consist of physical tests (lung function, muscle strength, physical capacity) and questionnaires (communication and swallowing, nutritional status, hearing, activities of daily living, physical activity, fatigue, cognition) longitudinally at 3, 6 and 12 months. Patient records auditing (care, rehabilitation) will be done retrospectively at 12 months. Patients (3, 6 and 12 months), next of kin (6 months) and health care staff (baseline, 3, 6, 9 and 12 months) will receive questionnaires regarding, health-related quality of life, depression, anxiety, sleeping disorders, and post-traumatic stress. Staff will also answer questionnaires about burnout and coping strategies. Interviews will be conducted in all three cohorts.Discussion: This study will be able to answer different research questions from a quantitative and qualitative perspective, by describing and evaluating long-term consequences and their associations with recovery, as well as exploring patients’, next of kins’ and staffs’ views and experiences of the disease and its consequences. This will form a base for a deeper and better understanding of the consequences of the disease from different perspectives as well as helping the society to better prepare for a future pandemic.
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