Breaking up Sedentary Time in Rheumatoid Arthritis

October 3, 2023 updated by: Liverpool John Moores University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L3 3AF
        • Recruiting
        • Research Institute for Sport and Exercise Sciences (RISES)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Middle cerebral artery mean velocity (MCAV)
Time Frame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
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
Time Frame: 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.
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Cerebral autoregulation
Time Frame: 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.
Change from baseline (hour 0) to hour 4 (post-intervention/control)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brachial artery endothelial function
Time Frame: 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.
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Finger blood pressure
Time Frame: 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.
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Superficial femoral artery endothelial function
Time Frame: 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.
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Skin blood flow response to hyperemia
Time Frame: 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.
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Stroop color-word test
Time Frame: 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.
Change from baseline (hour 0) to hour 4 (post-intervention/control)
California Verbal Learning Test-2
Time Frame: 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.
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Brachial artery blood flow
Time Frame: 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
Change from baseline to 1-hour/2-hour/3-hour/4-hour
Femoral artery blood flow
Time Frame: 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
Change from baseline to 1-hour/2-hour/3-hour/4-hour
Pain intensity
Time Frame: Change from baseline to 1-hour/2-hour/3-hour/4-hour
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liverpool John Moores University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Liverpool University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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