COVID-19 Clinical Trial
Official title:
The Effect of Uninterrupted and Interrupted Sitting on Vascular Health and Cognitive Function in People With Long COVID-19
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Park and St Francis | Winchester | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University of Winchester | University of Gloucestershire |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | DePaul Symptom Questionnaire: Post-Exertional Malaise (DSQ-PEM) | The DSQ-PEM is a 10 item questionnaire used to assess presence of post-exertional malaise based on the frequency and severity of symptoms. Items are scored from 0 to 4, with 0 relating to a low value and 4 relating to a high value. | Up to 72 hours, and weekly (up to 4 weeks) following each laboratory visit | |
Primary | Pulse Wave Velocity | Carotid femoral pulse wave velocity (PWV) using SphygmoCor XCEL. Lower numbers represent healthier PWV, and in turn better vascular health | Change from baseline to 120 minutes post baseline | |
Secondary | Central and peripheral pulse wave analysis | A non-invasive method of measuring blood pressure, arterial stiffness, how much time the heart spends pumping, and the ability of the arterial system to meet the heart's energy requirements | Change from baseline to 120 minutes post baseline | |
Secondary | Cognitive function | A two part cognitive assessment completed on an IPad using visual screening and working memory. Scores that are lower in time (seconds) and errors indicate better performance at the task | Change from baseline to 120 minutes post baseline | |
Secondary | Quality of Life - EuroQuol 5 Dimensions 5 levels (EQ-5D-5L) | 5-item questionnaire that assesses quality of life. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|