Rheumatoid ArthritisNCT05284110
Breaking up Sedentary Time in Rheumatoid Arthritis
A study testing Physical activity in people with Rheumatoid Arthritis and Sedentary Behavior, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Rheumatoid Arthritis, Sedentary Behavior, Endothelial Dysfunction
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Musculoskeletal impairment/disability precluding physical activity
- Unstable medication (change in medication within the 3 months)
- Aged <18 or > 60 yr
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Research Institute for Sport and Exercise Sciences (RISES)
Liverpool, Merseyside, L3 3AF
Daniel Bannell, MPhil, 07786008666 ext. 44, D.J.Bannell@2015.ljmu.ac.uk
David Low, PhD, 01519046244 ext. 44, d.a.low@ljmu.ac.uk
About this study
Official title: 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.
Read the 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.
- Being tested
- Physical activity
- Keywords
- physical activity, rheumatic diseases, vascular function
- Medical subject headings
- Arthritis, Rheumatoid, Sedentary Behavior, Motor Activity, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Also called Walking
Multiple bouts of 3-min brisk walking, every 30 min, for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Middle cerebral artery mean velocity (MCAV)
MCAV will be assessed using continuous bilateral transcranial Doppler ultrasound.
Measured: 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.
Measured: 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.
Measured: Change from baseline (hour 0) to hour 4 (post-intervention/control)
Secondary outcomes (9)
Brachial artery endothelial function
Brachial artery endothelial function will be assessed through flow-mediated dilation using vascular ultrasound.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Change from baseline to 1-hour/2-hour/3-hour/4-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Dec 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284110
- Sponsor's protocol ID
- BRAKETIME
- Status last verified
- Oct 2023
- First submitted
- 24 Feb 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking up Sedentary Time in Rheumatoid Arthritis: Effects on Vascular Function
- ClinicalTrials.gov ID
- NCT05284110
- Acronym / sponsor ID
- BRAKETIME
- Keywords
- physical activity, rheumatic diseases, vascular function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Walking breaks (WALK) | Experimental | Behavioral: Physical activityDuring 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. |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: WalkingMultiple bouts of 3-min brisk walking, every 30 min, for 4 hours. | Behavioural | Walking breaks (WALK) |
Primary outcome
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.
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.
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.
9 secondary outcomes
Brachial artery endothelial function
Time frame: 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)
Superficial femoral artery endothelial function
Time frame: 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)
Stroop color-word test
Time frame: 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)
Brachial artery blood flow
Time frame: 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
Pain intensity
Time frame: Change from baseline to 1-hour/2-hour/3-hour/4-hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Rheumatoid Arthritis and Sedentary Behavior, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Bannell, MPhil (07786008666 ext. 44, D.J.Bannell@2015.ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Middle cerebral artery mean velocity (MCAV) (time frame: Change from baseline (hour 0) to hour 4 (post-intervention/control)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023; AzTrials last refreshed its copy on 2 Nov 2026.