Arthritis, RheumatoidWIApNCT05301621
Accelerometry in Follow up of Arthritis - a Pilot Study
An observational study of Arthritis, Rheumatoid and Spondyloarthritis, run by Helse Forde at 1 site in Norway.
Trial summary
This is a proof-of-concept study. The main goal is to evaluate if the accelerometry signal recorded from patients with arthritis in different disease activity stages, allows for assessment of the activity status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Spondyloarthritis, Psoriatic Arthritis
- What is being tested?
- Akcelerometry follow up
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 12 May 2022to 31 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients will be collected from Rheumatologic outpatients clinic Helse Forde. Only patients with the active disease will be included.
Who may be able to join
- Patients:
- Clinical diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondyloarthritis (SPA).
- Planned or newly started (within 4 weeks before baseline visit) disease-modifying treatment.
- Disis activity defined as:
- RA - DAS28 (ESR or CRP) minimum 3.2,
- PsA - DAPSA minimum 15,
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- SPA - BASDAI minimum 4.0.
- A minimum number of tender or swollen joints:
- RA - 4/4,
- PsA - 2/2,
- SPA - not applicable.
- Subject without comorbidities defined in the exclusion criteria.
- Willing to participate and consent competent.
- Over 18 years old.
- Controls:
- Without any inflammatory rheumatic disease
- Without any comorbidity as defined in the exclusion criteria.
- Willing to participate and consent competent.
- Over 18 years old.
Who cannot join
- Both patients and controls:
- Chronic neurologic disorders such as multiple sclerosis, parkinsonism, active epilepsy, symptomatic peripheral neuropathy, sequels after radiculopathy or other central nervous system deficit.
- Paresis after cerebral stroke (mild deficits or TIA can be allowed).
- Serious heart failure (NYHA 3 or above).
- Pregnancy.
- Active psychotic disorder.
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- Activ alcohol or drug addiction.
- Fast use of medicine that can significantly influence CNS function (low dose sleeping medicine 12 hours before a visit can be allowed).
- Spinal compression fractures less than six months before baseline.
- Other limb fractures, within 4 months before baseline if it can influence patient's mobility
- Other medical conditions that can influence patient's mobility
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Pawel Mielnik
Førde, Vestlandet, 6812
Pawel Mielnik, MD, PhD, +47 57839000, post@helse-forde.no
About this study
This is a proof-of-concept study. The main goal is to evaluate if the accelerometry signal recorded from patients with arthritis in different disease activity stages, allows for assessment of the activity status. It will also be analysed if the accelerometry signal can be classified as registered in arthritis patients vs. registered in healthy control. Arthritis subjects will be recruited from the outpatients' clinic of the Rheumatology Department Helse Førde, Førde, Norway. Healthy control subjects will be recruited from the same administrative area as the patients and will be invited to participate via announcement on the Helse Forde Medical Trust website. Four visits to the site are planned for the arthritis group and one for the control group. The patients will be recruited in the active phase of arthritis as defined in the inclusion criteria.
The study's secondary objective is to develop methods for analysing the accelerometry signal in arthritis patients.
Read the detailed description
Study type: Observational, proof-of-concept
Objectives:
Primary objective: To evaluate if an accelerometer signal in patients with active arthritis differs from the signal taken in inactive arthritis and healthy individuals.
Secondary goals:
- To evaluate how the accelerometer signal differs depending on the disease activity status
- To elaborate the methods for analysing accelerometry in the arthritis patients
- To build knowledge and data for future studies
- To evaluate software and hardware used
Subjects and methods:
Subjects will be recruited two groups:
- Patient with one of the following conditions: rheumatoid arthritis, psoriatic arthritis or spondyloarthritis. All subjects must satisfy inclusion/exclusion criteria.
- Healthy individuals as defined in inclusion/exclusion criteria
The arthritis patients with active disease will be included from the outpatients clinic of the Rheumatology Department Helse Førde Medical Trust. The healthy controls will be recruited via announcement on the Helse Førde website. The maximum number of participants is estimated for 50 subjects per group.
There will be four visits in the arthritis group and a single visit in the control group.
Following data will be collected:
For both groups: age, gender, anthropometric data (high, weight, limbs length), information about comorbidities and used drugs.
Additionally, from arthritis patients disease activity data will be collected: tender joint count, swollen joint count, overall patients/physician assessment, MHAQ, BASDAI, CRP and ESR.
At all visits, ball participants will perform a set of simple physical activities such as walking, clapping, arm swinging, and moving small subjects on the table. The accelerometry signal will be recorded during those exercises.
Study management:
An interim analysis is planned after data is collected from the first 5-10 participants. The steering committee will assess study progress at this stage and decide about further study conduct.
- Being tested
- Akcelerometry follow up
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akcelerometry follow upOther
The patients and control group will be followed up with single accelerometer.
| Study group | Role | What they receive |
|---|---|---|
| Arthritis patients | It is not planned any intervention. The patients' group will be invited to 4 visits. Receives: Other: Akcelerometry follow up | |
| Healthy controls | No intervention planned. Only one visit will be conducted. Receives: Other: Akcelerometry follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of arthritis activity status
Analysis of raw akcelerometry will be used to detect disease activity status
Measured: 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start12 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Forde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Mielnik, Helse Forde
- Investigators
- Pawel Mielnik, MD, PhD, Principal investigator, Helse Forde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301621
- Sponsor's protocol ID
- 249395
- Acronym
- WIAp
- Status last verified
- Aug 2022
- First submitted
- 19 Mar 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerometry in Follow up of Arthritis - a Pilot Study
- ClinicalTrials.gov ID
- NCT05301621
- Acronym / sponsor ID
- WIAp / 249395
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helse FordeUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 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 is a proof-of-concept study. The main goal is to evaluate if the accelerometry signal recorded from patients with arthritis in different disease activity stages, allows for assessment of the activity status. It will also be analysed if the accelerometry signal can be classified as registered in arthritis patients vs. registered in healthy control. Arthritis subjects will be recruited from the outpatients' clinic of the Rheumatology Department Helse Førde, Førde, Norway. Healthy control subjects will be recruited from the same administrative area as the patients and will be invited to participate via announcement on the Helse Forde Medical Trust website. Four visits to the site are planned for the arthritis group and one for the control group. The patients will be recruited in the active phase of arthritis as defined in the inclusion criteria.
The study's secondary objective is to develop methods for analysing the accelerometry signal in arthritis patients.
Detailed description
Study type: Observational, proof-of-concept
Objectives:
Primary objective: To evaluate if an accelerometer signal in patients with active arthritis differs from the signal taken in inactive arthritis and healthy individuals.
Secondary goals:
- To evaluate how the accelerometer signal differs depending on the disease activity status
- To elaborate the methods for analysing accelerometry in the arthritis patients
- To build knowledge and data for future studies
- To evaluate software and hardware used
Subjects and methods:
Subjects will be recruited two groups:
- Patient with one of the following conditions: rheumatoid arthritis, psoriatic arthritis or spondyloarthritis. All subjects must satisfy inclusion/exclusion criteria.
- Healthy individuals as defined in inclusion/exclusion criteria
The arthritis patients with active disease will be included from the outpatients clinic of the Rheumatology Department Helse Førde Medical Trust. The healthy controls will be recruited via announcement on the Helse Førde website. The maximum number of participants is estimated for 50 subjects per group.
There will be four visits in the arthritis group and a single visit in the control group.
Following data will be collected:
For both groups: age, gender, anthropometric data (high, weight, limbs length), information about comorbidities and used drugs.
Additionally, from arthritis patients disease activity data will be collected: tender joint count, swollen joint count, overall patients/physician assessment, MHAQ, BASDAI, CRP and ESR.
At all visits, ball participants will perform a set of simple physical activities such as walking, clapping, arm swinging, and moving small subjects on the table. The accelerometry signal will be recorded during those exercises.
Study management:
An interim analysis is planned after data is collected from the first 5-10 participants. The steering committee will assess study progress at this stage and decide about further study conduct.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthritis patients | – | Other: Akcelerometry follow upIt is not planned any intervention. The patients' group will be invited to 4 visits. |
| Healthy controls | – | Other: Akcelerometry follow upNo intervention planned. Only one visit will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be collected from Rheumatologic outpatients clinic Helse Forde. Only patients with the active disease will be included.
Key inclusion criteria (19 listed)
- Clinical diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondyloarthritis (SPA).
- Planned or newly started (within 4 weeks before baseline visit) disease-modifying treatment.
- Disis activity defined as:
- A minimum number of tender or swollen joints:
- Subject without comorbidities defined in the exclusion criteria.
Key exclusion criteria (11 listed)
- Chronic neurologic disorders such as multiple sclerosis, parkinsonism, active epilepsy, symptomatic peripheral neuropathy, sequels after radiculopathy or other central nervous system deficit.
- Paresis after cerebral stroke (mild deficits or TIA can be allowed).
- Serious heart failure (NYHA 3 or above).
- Pregnancy.
- Active psychotic disorder.
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 |
|---|---|---|
| Akcelerometry follow upThe patients and control group will be followed up with single accelerometer. | Other | Arthritis patients, Healthy controls |
Primary outcome
Detection of arthritis activity status
Time frame: 2023
Analysis of raw akcelerometry will be used to detect disease activity status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- 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.
Pawel Mielnik, MD, PhD principal investigator
Helse Forde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Spondyloarthritis, run by Helse Forde at 1 site in Norway.
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 19 inclusion and 11 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 16 Aug 2022. 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 Norway. 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 Pawel Mielnik, MD, PhD (+ 4757839000, post@helse-forde.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of arthritis activity status (time frame: 2023). 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 16 Aug 2022.