Uninterrupted and Interrupted Sitting in Long COVID-19

NCT05453175 | Completed

• 1 other identifier: UoW_Faulkner_LCOVID_22
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Central and peripheral pulse wave analysis

  Change from baseline to 120 minutes post baseline

• Cognitive function

  Change from baseline to 120 minutes post baseline

• Quality of Life - EuroQuol 5 Dimensions 5 levels (EQ-5D-5L)

  Baseline

Other Outcomes (1)

• DePaul Symptom Questionnaire: Post-Exertional Malaise (DSQ-PEM)

  Up to 72 hours, and weekly (up to 4 weeks) following each laboratory visit

Study Arms (2)

Interrupting sitting

EXPERIMENTAL

Participants will engage in low intensity physical activity every thirty minutes up to 120 minutes

Other: Interrupting sitting with Physical activity

Control

NO INTERVENTION

Participants will remain seated for the entire 120 minutes

Interventions

Interrupting sitting with Physical activity OTHER

Participants will engage in three minutes of walking, five sit to stands and five calf raises every thirty minutes

Interrupting sitting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Winchester: lead
• University of Gloucestershire: collaborator

Study Sites (1)

Park and St Francis

Winchester, Hampshire, SO53 2ZH, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James Faulkner, PhD

  University of Winchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 12, 2022
• Study Start: October 7, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Starting after 6 months of publication
• Access Criteria: Available to all researchers interested in long covid research

Locations

GB (1)