Accelerometry in Follow up of Arthritis - a Pilot Study

Study Purpose

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.#46; 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05301621
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Helse Forde
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pawel Mielnik, MD, PhD
Principal Investigator Affiliation Helse Forde
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Rheumatoid, Spondyloarthritis, Psoriatic Arthritis
Additional Details

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.

Arms & Interventions

Arms

: Arthritis patients

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

: Healthy controls

No intervention planned. Only one visit will be conducted.

Interventions

Other: - Akcelerometry follow up

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

Contact a Trial Team

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International Sites

Pawel Mielnik, Forde, Vestlandet, Norway

Status

Recruiting

Address

Pawel Mielnik

Forde, Vestlandet, 6812

Site Contact

Pawel Mielnik, MD, PhD

[email protected]

+47 57839000

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