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Status unknownNCT05301621WIApUpdated Aug 16, 2022

Accelerometry in Follow up of Arthritis - a Pilot Study

An observational study in Arthritis, Rheumatoid, Spondyloarthritis and Psoriatic Arthritis, sponsored by Helse Forde. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.

Sponsored by Helse Forde · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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. 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:

  1. Patient with one of the following conditions: rheumatoid arthritis, psoriatic arthritis or spondyloarthritis. All subjects must satisfy inclusion/exclusion criteria.
  2. 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.

02

Conditions studied

  • Arthritis, Rheumatoid
  • Spondyloarthritis
  • Psoriatic Arthritis
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's planned enrollment of 100 is below the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Helse Forde is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients will be collected from Rheumatologic outpatients clinic Helse Forde. Only patients with the active disease will be included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients:

  1. Clinical diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondyloarthritis (SPA).
  2. Planned or newly started (within 4 weeks before baseline visit) disease-modifying treatment.

  3. Disis activity defined as:

    • RA - DAS28 (ESR or CRP) minimum 3.2,
    • PsA - DAPSA minimum 15,
    • SPA - BASDAI minimum 4.0.

  4. A minimum number of tender or swollen joints:

    • RA - 4/4,
    • PsA - 2/2,
    • SPA - not applicable.
  5. Subject without comorbidities defined in the exclusion criteria.
  6. Willing to participate and consent competent.
  7. Over 18 years old.

Controls:

  1. Without any inflammatory rheumatic disease
  2. Without any comorbidity as defined in the exclusion criteria.
  3. Willing to participate and consent competent.
  4. Over 18 years old.

Exclusion criteria

Exclusion Criteria:

Both patients and controls:

  1. Chronic neurologic disorders such as multiple sclerosis, parkinsonism, active epilepsy, symptomatic peripheral neuropathy, sequels after radiculopathy or other central nervous system deficit.
  2. Paresis after cerebral stroke (mild deficits or TIA can be allowed).
  3. Serious heart failure (NYHA 3 or above).
  4. Pregnancy.
  5. Active psychotic disorder.
  6. Activ alcohol or drug addiction.
  7. Fast use of medicine that can significantly influence CNS function (low dose sleeping medicine 12 hours before a visit can be allowed).
  8. Spinal compression fractures less than six months before baseline.
  9. Other limb fractures, within 4 months before baseline if it can influence patient's mobility
  10. Other medical conditions that can influence patient's mobility
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Arthritis patients

    It is not planned any intervention. The patients' group will be invited to 4 visits.

    Other: Akcelerometry follow up

  • Healthy controls

    No intervention planned. Only one visit will be conducted.

    Other: Akcelerometry follow up

Interventions

  • OtherAkcelerometry follow up

    The patients and control group will be followed up with single accelerometer.

06

What researchers measure

Primary outcomes

  1. Detection of arthritis activity status

    Analysis of raw akcelerometry will be used to detect disease activity status

    Time frame: 2023

07

Study locations

1 of 1 sites recruiting
  • Pawel Mielnik
    Førde, Vestlandet 6812, Norway
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Dec 2023, 19 months after the start.

Of 196 non-industry observational studies under Arthritis, Rheumatoid, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 96. This study's planned 19 months is below that.

Counting every sponsor, half of 317 studies reached it within 47 months; a quarter within 24 and three quarters within 93.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2022
First posted
Mar 31, 2022
StartActual
May 12, 2022
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2023
Last update
Aug 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05301621
Lead sponsor
Helse Forde
Responsible party
Pawel Mielnik (Consultant in Rheumatology, Helse Forde) — Principal investigator
First posted
Mar 31, 2022
Start date
May 12, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Aug 16, 2022

Study contacts

Pawel Mielnik, MD, PhD
Contact
post@helse-forde.no
+ 4757839000
Pawel Mielnik, MD, PhD
principal investigator · Helse Forde

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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