Breaking up Sedentary Time in Rheumatoid Arthritis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Endothelial Dysfunction; Sedentary Behavior
• Intervention / Treatment: Behavioral: Physical activity

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Bannell, MPhil; Phone Number: 44 07786008666; Email: D.J.Bannell@2015.ljmu.ac.uk
• Study Contact Backup: Name: David Low, PhD; Phone Number: 44 01519046244; Email: d.a.low@ljmu.ac.uk

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L3 3AF
      • Recruiting
      • Research Institute for Sport and Exercise Sciences (RISES)
      • Contact: Daniel Bannell, MPhil; Phone Number: 44 07786008666; Email: D.J.Bannell@2015.ljmu.ac.uk
      • Contact: David Low, PhD; Phone Number: 44 01519046244; Email: d.a.low@ljmu.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking breaks (WALK); During this session, participants will be requested to remain seated during 4 hours, but the sitting will be interrupted every 30 min with a 3-min light-intensity walking.	Behavioral: Physical activity; Multiple bouts of 3-min brisk walking, every 30 min, for 4 hours.; Other Names: Walking
No Intervention: Prolonged sitting (SIT); During this session, participants be requested to remain seated during 4 uninterrupted hours (excepted for visiting the toilet) in a comfortable chair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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
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
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

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Collaborators: Liverpool University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; vascular function; rheumatic diseases
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: BRAKETIME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No