Breaking up Sedentary Time in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis, Sedentary Behavior, Endothelial Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physical activity
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis focused on measuring physical activity, rheumatic diseases, vascular function
Eligibility Criteria
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
Sites / Locations
- Research Institute for Sport and Exercise Sciences (RISES)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Walking breaks (WALK)
Prolonged sitting (SIT)
Arm Description
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.
During this session, participants be requested to remain seated during 4 uninterrupted hours (excepted for visiting the toilet) in a comfortable chair
Outcomes
Primary Outcome Measures
Middle cerebral artery mean velocity (MCAV)
MCAV will be assessed using continuous bilateral transcranial Doppler ultrasound.
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.
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.
Secondary Outcome Measures
Brachial artery endothelial function
Brachial artery endothelial function will be assessed through flow-mediated dilation using vascular ultrasound.
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.
Superficial femoral artery endothelial function
Superficial femoral artery endothelial function will be assessed through flow-mediated dilation using vascular ultrasound.
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.
Stroop color-word test
The Stroop color-word test will be implemented to assess attention and inhibitory control.
California Verbal Learning Test-2
Immediate recall of the California Verbal Learning Test-2 will be used to assess verbal learning and memory.
Brachial artery blood flow
Vascular ultrasound will be used to assess brachial artery blood flow every hour during the intervention
Femoral artery blood flow
Vascular ultrasound will be used to assess femoral artery blood flow every hour during the intervention
Pain intensity
Pain intensity will be assessed using a 10cm visual analogue scale.
Full Information
NCT ID
NCT05284110
First Posted
February 24, 2022
Last Updated
October 3, 2023
Sponsor
Liverpool John Moores University
Collaborators
Liverpool University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05284110
Brief Title
Breaking up Sedentary Time in Rheumatoid Arthritis
Official Title
Breaking up Sedentary Time in Rheumatoid Arthritis: Effects on Vascular Function
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool John Moores University
Collaborators
Liverpool University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Sedentary Behavior, Endothelial Dysfunction
Keywords
physical activity, rheumatic diseases, vascular function
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The researcher who will perform the vascular analysis will be blinded to the allocation order.
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Walking breaks (WALK)
Arm Type
Experimental
Arm Description
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.
Arm Title
Prolonged sitting (SIT)
Arm Type
No Intervention
Arm Description
During this session, participants be requested to remain seated during 4 uninterrupted hours (excepted for visiting the toilet) in a comfortable chair
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Other Intervention Name(s)
Walking
Intervention Description
Multiple bouts of 3-min brisk walking, every 30 min, for 4 hours.
Primary Outcome Measure Information:
Title
Middle cerebral artery mean velocity (MCAV)
Description
MCAV will be assessed using continuous bilateral transcranial Doppler ultrasound.
Time Frame
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Title
Middle cerebral artery mean velocity reactivity to carbon dioxide
Description
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.
Time Frame
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Title
Cerebral autoregulation
Description
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.
Time Frame
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary Outcome Measure Information:
Title
Brachial artery endothelial function
Description
Brachial artery endothelial function will be assessed through flow-mediated dilation using vascular ultrasound.
Time Frame
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Title
Finger blood pressure
Description
During all procedures, beat by beat finger blood pressure will be measured on the middle finger of the right hand using photoplethysmography.
Time Frame
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Title
Superficial femoral artery endothelial function
Description
Superficial femoral artery endothelial function will be assessed through flow-mediated dilation using vascular ultrasound.
Time Frame
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Title
Skin blood flow response to hyperemia
Description
Skin blood flow response to hyperemia will be assessed using a laser doppler probe attached to the shin and forearm.
Time Frame
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Title
Stroop color-word test
Description
The Stroop color-word test will be implemented to assess attention and inhibitory control.
Time Frame
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Title
California Verbal Learning Test-2
Description
Immediate recall of the California Verbal Learning Test-2 will be used to assess verbal learning and memory.
Time Frame
Change from baseline (hour 0) to hour 4 (post-intervention/control)
Title
Brachial artery blood flow
Description
Vascular ultrasound will be used to assess brachial artery blood flow every hour during the intervention
Time Frame
Change from baseline to 1-hour/2-hour/3-hour/4-hour
Title
Femoral artery blood flow
Description
Vascular ultrasound will be used to assess femoral artery blood flow every hour during the intervention
Time Frame
Change from baseline to 1-hour/2-hour/3-hour/4-hour
Title
Pain intensity
Description
Pain intensity will be assessed using a 10cm visual analogue scale.
Time Frame
Change from baseline to 1-hour/2-hour/3-hour/4-hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Bannell, MPhil
Phone
07786008666
Ext
44
Email
D.J.Bannell@2015.ljmu.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
David Low, PhD
Phone
01519046244
Ext
44
Email
d.a.low@ljmu.ac.uk
Facility Information:
Facility Name
Research Institute for Sport and Exercise Sciences (RISES)
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L3 3AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Bannell, MPhil
Phone
07786008666
Ext
44
Email
D.J.Bannell@2015.ljmu.ac.uk
First Name & Middle Initial & Last Name & Degree
David Low, PhD
Phone
01519046244
Ext
44
Email
d.a.low@ljmu.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Breaking up Sedentary Time in Rheumatoid Arthritis
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