Breaking up Sedentary Time in Rheumatoid Arthritis

Not Applicable

Recruiting

• Conditions: Endothelial Dysfunction; Rheumatoid Arthritis; Sedentary Behavior

• Registration Number: NCT05284110
• Lead Sponsor: Liverpool John Moores University

Brief Summary

This study will verify the effects of breaking up sitting time with short bouts of light intensity walking on vascular function in women with rheumatoid arthritis.

Detailed Description

Women diagnosed with rheumatoid arthritis will participate in this randomized crossover trial. In one of the experimental sessions, the participants will remain 4-h on uninterrupted sitting, and in another day they will perform 3-min light intensity walk every 30 min to break up the sitting position. Vascular function will be assessed before and after each intervention using the following devices/techniques: a) transcranial Doppler ultrasound to assess the middle cerebral artery blood flow velocity at baseline and in response to CO2 breathing (5% CO2 mixture for 3 min), and to repeated sit-to-stand transitions; b) a multi-frequency linear transducer (7-12 MHz) attached to a high-resolution ultrasound machine to assess femoral artery dilation after reactive hyperemia (i.e., flow-mediated dilation); c) a laser Doppler probe attached to the skin surface of the right shin in order to quantify the Laser Doppler flux at baseline and during reactive hyperemia. Additionally, healthy age- and body mass-matched women will be recruited and will only perform the pre-intervention tests.

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Study Start: 2022-12-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-04-30
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Adult women diagnosed with RA
• From the Rheumatology Clinic at the Liverpool University Hospitals NHS Foundation Trust
• Aged 18-60 yr
• Non-smoker for at least 6months
• Able to provide written informed consent.

Exclusion Criteria

• Cannot readily read and understand English.
• Currently smoking or within last 6 months.
• Alcohol consumption >14units per week.
• Symptoms of or established cardiovascular disease (except hypertension)
• Previous stroke or myocardial infarction.
• History of diabetes or respiratory disease or chronic kidney disease.
• Musculoskeletal impairment/disability precluding physical activity
• Unstable medication (change in medication within the 3 months)
• Aged <18 or > 60 yr
• Currently pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Middle cerebral artery mean velocity (MCAV)	Change from baseline (hour 0) to hour 4 (post-intervention/control)	MCAV will be assessed using continuous bilateral transcranial Doppler ultrasound.
Middle cerebral artery mean velocity reactivity to carbon dioxide	Change from baseline (hour 0) to hour 4 (post-intervention/control)	Participants will breathe a 5% carbon dioxide mixture for 3 min during which time MCAV reactivity to CO2 will be assessed using continuous bilateral transcranial Doppler ultrasound.
Cerebral autoregulation	Change from baseline (hour 0) to hour 4 (post-intervention/control)	Participants will be asked to complete a series of repeated sit to stand moves (coached by a member of the research team) for a 5-minute period, during which time MCAV will be assessed using continuous bilateral transcranial Doppler ultrasound. Beat by beat blood pressure will also be assessed using finger photoplethysmography.

Secondary Outcome Measures

Name	Time	Method
Brachial artery endothelial function	Change from baseline (hour 0) to hour 4 (post-intervention/control)	Brachial artery endothelial function will be assessed through flow-mediated dilation using vascular ultrasound.
Brachial artery blood flow	Change from baseline to 1-hour/2-hour/3-hour/4-hour	Vascular ultrasound will be used to assess brachial artery blood flow every hour during the intervention
Femoral artery blood flow	Change from baseline to 1-hour/2-hour/3-hour/4-hour	Vascular ultrasound will be used to assess femoral artery blood flow every hour during the intervention
Pain intensity	Change from baseline to 1-hour/2-hour/3-hour/4-hour	Pain intensity will be assessed using a 10cm visual analogue scale.
Skin blood flow response to hyperemia	Change from baseline (hour 0) to hour 4 (post-intervention/control)	Skin blood flow response to hyperemia will be assessed using a laser doppler probe attached to the shin and forearm.
Stroop color-word test	Change from baseline (hour 0) to hour 4 (post-intervention/control)	The Stroop color-word test will be implemented to assess attention and inhibitory control.
Superficial femoral artery endothelial function	Change from baseline (hour 0) to hour 4 (post-intervention/control)	Superficial femoral artery endothelial function will be assessed through flow-mediated dilation using vascular ultrasound.
California Verbal Learning Test-2	Change from baseline (hour 0) to hour 4 (post-intervention/control)	Immediate recall of the California Verbal Learning Test-2 will be used to assess verbal learning and memory.
Finger blood pressure	Change from baseline (hour 0) to hour 4 (post-intervention/control)	During all procedures, beat by beat finger blood pressure will be measured on the middle finger of the right hand using photoplethysmography.

Trial Locations

Locations (1)

Research Institute for Sport and Exercise Sciences (RISES); 🇬🇧 Liverpool, Merseyside, United Kingdom