Clinical trial NCT05284110: Breaking up Sedentary Time in Rheumatoid Arthritis
Official title: Breaking up Sedentary Time in Rheumatoid Arthritis: Effects on Vascular Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Sedentary Behavior
Endothelial Dysfunction
Keywords: physical activity
rheumatic diseases
vascular function
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Liverpool University Hospitals NHS Foundation Trust
First posted: 2022-03-17
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Middle cerebral artery mean velocity (MCAV)
timeFrame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
measure: Middle cerebral artery mean velocity reactivity to carbon dioxide
timeFrame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
measure: Cerebral autoregulation
timeFrame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary outcomes:
measure: Brachial artery endothelial function
timeFrame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
measure: Finger blood pressure
timeFrame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
measure: Superficial femoral artery endothelial function
timeFrame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
measure: Skin blood flow response to hyperemia
timeFrame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
measure: Stroop color-word test
timeFrame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
measure: California Verbal Learning Test-2
timeFrame: Change from baseline (hour 0) to hour 4 (post-intervention/control)
measure: Brachial artery blood flow
timeFrame: Change from baseline to 1-hour/2-hour/3-hour/4-hour
measure: Femoral artery blood flow
timeFrame: Change from baseline to 1-hour/2-hour/3-hour/4-hour
measure: Pain intensity
timeFrame: Change from baseline to 1-hour/2-hour/3-hour/4-hour
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Research Institute for Sport and Exercise Sciences (RISES)
state: Merseyside
Study officials:
References: