Breaking up Sedentary Time in Rheumatoid Arthritis

NCT05284110 | Unknown

• 1 other identifier: BRAKETIME
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Sedentary Behavior; Endothelial Dysfunction

Keywords

physical activity; rheumatic diseases; vascular function

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Brachial artery endothelial function

  Change from baseline (hour 0) to hour 4 (post-intervention/control)

• Finger blood pressure

  Change from baseline (hour 0) to hour 4 (post-intervention/control)

• Superficial femoral artery endothelial function

  Change from baseline (hour 0) to hour 4 (post-intervention/control)

• Skin blood flow response to hyperemia

  Change from baseline (hour 0) to hour 4 (post-intervention/control)

• Stroop color-word test

  Change from baseline (hour 0) to hour 4 (post-intervention/control)

Study Arms (2)

Walking breaks (WALK)

EXPERIMENTAL

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

Prolonged sitting (SIT)

NO INTERVENTION

During this session, participants be requested to remain seated during 4 uninterrupted hours (excepted for visiting the toilet) in a comfortable chair

Interventions

Physical activity BEHAVIORAL

Multiple bouts of 3-min brisk walking, every 30 min, for 4 hours.

Also known as: Walking

Walking breaks (WALK)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Research Institute for Sport and Exercise Sciences (RISES)

Liverpool, Merseyside, L3 3AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sedentary Behavior; Motor Activity; Rheumatic Diseases

Interventions

Exercise; Walking

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Daniel Bannell, MPhil

CONTACT

07786008666; D.J.Bannell@2015.ljmu.ac.uk

David Low, PhD

CONTACT

01519046244; d.a.low@ljmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who will perform the vascular analysis will be blinded to the allocation order.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with rheumatoid arthritis will attend the laboratory at Liverpool John Moores University on 2 occasions. During these visits, they will be submitted to the intervention or the control and will also undertake a series vascular tests prior- and post-intervention/control.

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 17, 2022
• Study Start: December 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: December 1, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)