Breaking up Sedentary Time in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Breaking up Sedentary Time in Rheumatoid Arthritis: Effects on Vascular Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05284110
• Other study ID #: BRAKETIME
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Liverpool John Moores University
• Contact: Daniel Bannell, MPhil
• Phone: 07786008666
• Email: D.J.Bannell[@]2015.ljmu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Endothelial Dysfunction
• Rheumatoid Arthritis
• Sedentary Behavior

Intervention

Behavioral:
• Physical activity
Multiple bouts of 3-min brisk walking, every 30 min, for 4 hours.

Locations

Country	Name	City	State
United Kingdom	Research Institute for Sport and Exercise Sciences (RISES)	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool John Moores University	Liverpool University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Middle cerebral artery mean velocity (MCAV)	MCAV will be assessed using continuous bilateral transcranial Doppler ultrasound.	Change from baseline (hour 0) to hour 4 (post-intervention/control)
Primary	Middle cerebral artery mean velocity reactivity to carbon dioxide	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.	Change from baseline (hour 0) to hour 4 (post-intervention/control)
Primary	Cerebral autoregulation	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.	Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary	Brachial artery endothelial function	Brachial artery endothelial function will be assessed through flow-mediated dilation using vascular ultrasound.	Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary	Finger blood pressure	During all procedures, beat by beat finger blood pressure will be measured on the middle finger of the right hand using photoplethysmography.	Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary	Superficial femoral artery endothelial function	Superficial femoral artery endothelial function will be assessed through flow-mediated dilation using vascular ultrasound.	Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary	Skin blood flow response to hyperemia	Skin blood flow response to hyperemia will be assessed using a laser doppler probe attached to the shin and forearm.	Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary	Stroop color-word test	The Stroop color-word test will be implemented to assess attention and inhibitory control.	Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary	California Verbal Learning Test-2	Immediate recall of the California Verbal Learning Test-2 will be used to assess verbal learning and memory.	Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary	Brachial artery blood flow	Vascular ultrasound will be used to assess brachial artery blood flow every hour during the intervention	Change from baseline to 1-hour/2-hour/3-hour/4-hour
Secondary	Femoral artery blood flow	Vascular ultrasound will be used to assess femoral artery blood flow every hour during the intervention	Change from baseline to 1-hour/2-hour/3-hour/4-hour
Secondary	Pain intensity	Pain intensity will be assessed using a 10cm visual analogue scale.	Change from baseline to 1-hour/2-hour/3-hour/4-hour