The Effect of Uninterrupted and Interrupted Sitting on Vascular Health and Cognitive Function in People with Long COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Pulse Wave Velocity
研究概览
简要总结
People who sit uninterrupted for prolonged periods time have been shown to have poorer cardiovascular health compared to those that regularly interrupt it (e.g. standing up and moving). Cognition and brain function has also been shown to be impaired following uninterrupted sitting. Research has shown that interrupting sitting with exercise improves cardiovascular health in healthy men and women cognition, feeling of fatigue and cerebral oxygenation. Low intensity physical activity can help people with Long coronavirus disease (COVID) by reducing feelings of fatigue.
Individuals with long COVID have symptoms such as fatigue and brain fog. As such, people with long COVID may spend more time sitting during the day and demonstrate worsened cardiovascular and cognitive health. As such, there may be greater levels of cognitive decline and worsened cardiovascular health outcomes. In this study the investigators are interested in assessing the cardiovascular health and brain function of people with (and without) long COVID before and after uninterrupted and interrupted sitting.
Interruptions will be every 30 minutes during a 120 minute sitting period. Interruptions are self-paced and include up to three minutes of walking, five heel raises and five sit-to-stands at each interruption. To ensure external validity of the project, all interruptions are functional activities which can be reproducible in a home environment. Vascular health and cognitive function will be assessed before and after the interrupted and uninterrupted trials. Eligible participants will be aged over 18 years, have displayed symptoms of long COVID for more than 4 weeks, and have been diagnosed with long COVID via their GP or through a long COVID clinic. Involvement in the study will include three visits to a physiology laboratory at the University of Winchester or University of Gloucestershire. Involvement can be expected to last up to 40 days to account for the necessary time required between laboratory visits.
详细描述
Design:
The present study will be a laboratory study. The intervention group being persons suffering from Long COVID, and the control group being a healthy aged match group. Both the experimental and control groups will be randomised into either performing uninterrupted or interrupted sitting first to reduce the risk of order and learning effects associated with the trials. All individuals who are identified from general practitioner (GP) practices (e.g. Park and St Francis Surgery, Chandlers Ford near Winchester or associated surgeries and clinics) or long COVID clinics (e.g. Gloucestershire Health and Care NHS (National Health Service) Foundation Trust, Post Covid Syndrome Service and Southampton and Isle of Wight Long Covid Clinic, Solent NHS Trust, Southern Health NHS Trust and Isle of Wight NHS Trust), who meet the inclusion criteria will be provided with equal opportunity to engage with the study provided they are able to travel to either the University of Winchester or University of Gloucestershire for assessment. Healthy participants who will form the control group will also have equal opportunity to engage with the study providing they meet the inclusion criteria and are able to travel to either the University of Winchester or University of Gloucestershire for assessment.
The purpose and design of this study has been discussed with all members of the study team, and at a Patient and Public Involvement (PPI) meeting, with people currently suffering from Long COVID.
Recruitment:
Potential participants will initially be identified by the healthcare team at Park and St Francis Surgery, the Gloucestershire Health and Care NHS Foundation Trust, Post Covid Syndrome Service, Southampton and Isle of Wight Long Covid Clinic, Solent NHS Trust, Southern Health NHS Trust and Isle of Wight NHS Trust or associated surgeries and clinics according to study inclusion/exclusion criteria. The clinical team will gain documented verbal consent from potential participants for their contact details to be provided to the research team at the University of Winchester (Prof. James Faulkner, Dr Helen Ryan-Stewart and Mr Nick Hudson) and University of Gloucestershire (Dr Simon Fryer, Dr Keeron Stone and Mr Callum Thomas) who will then contact patients directly to discuss their potential participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Diagnosis of COVID-19 (via the NHS by polymerase chain reaction (PCR)/lateral flow positive results or by clinical diagnosis based on set criteria)
- •Clinical diagnosis of Long COVID, reported by a GP, defined as 'signs and symptoms that develop during or following an infection consistent with COVID-19 which continue for more than 4 weeks and are not explained by an alternative diagnosis' (NICE guidelines, October 2020).
- •Minimum age of 18 years
- •Cognitively aware of task demands
排除标准
- •Unable to undertake necessary physical activity for the study Unable to remain seated for 120 minutes at a time Unstable cardiovascular conditions
- •People with diabetes
- •People with dementia
- •Recent (previous 6 months) moderate to severe injury of the lower extremities
- •No positive COVID test or signs and symptoms within 6 weeks for healthy control
- •No positive COVID test within 4 weeks for Long COVID group
结局指标
主要结局
Pulse Wave Velocity
时间窗: Change from baseline to 120 minutes post baseline
Carotid femoral pulse wave velocity (PWV) using SphygmoCor XCEL. Lower numbers represent healthier PWV, and in turn better vascular health
次要结局
- Quality of Life - EuroQuol 5 Dimensions 5 levels (EQ-5D-5L)(Baseline)
- Central and peripheral pulse wave analysis(Change from baseline to 120 minutes post baseline)
- Cognitive function(Change from baseline to 120 minutes post baseline)