- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05301621
Accelerometry in Follow up of Arthritis - a Pilot Study (WIAp)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pawel Mielnik, MD, PhD
- Phone Number: + 4757839000
- Email: post@helse-forde.no
Study Locations
-
-
Vestlandet
-
Forde, Vestlandet, Norway, 6812
- Recruiting
- Pawel Mielnik
-
Contact:
- Pawel Mielnik, MD, PhD
- Phone Number: +47 57839000
- Email: post@helse-forde.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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,
- 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.
Exclusion Criteria:
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.
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Arthritis patients
It is not planned any intervention.
The patients' group will be invited to 4 visits.
|
The patients and control group will be followed up with single accelerometer.
|
Healthy controls
No intervention planned.
Only one visit will be conducted.
|
The patients and control group will be followed up with single accelerometer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of arthritis activity status
Time Frame: 2023
|
Analysis of raw akcelerometry will be used to detect disease activity status
|
2023
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pawel Mielnik, MD, PhD, Helse Forde
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Psoriasis
- Bone Diseases, Infectious
- Arthritis
- Arthritis, Rheumatoid
- Arthritis, Psoriatic
- Spondylitis
- Spondylarthritis
Other Study ID Numbers
- 249395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthritis, Rheumatoid
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Universidad Autonoma de Nuevo LeonCompletedRheumatoId ArthritisMexico
-
Hamad Medical CorporationUnknownRHEUMATOID ARTHRITISQatar
Clinical Trials on Akcelerometry follow up
-
Istanbul University - Cerrahpasa (IUC)CompletedInfertility | Psychological Distress | Infertility, Female | Depression, Anxiety | Nurse's RoleTurkey
-
M.D. Anderson Cancer CenterRecruitingRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
Connolly Hospital BlanchardstownCompletedGeneral Surgery | Outpatients | Virtual Clinic | Text MessagingIreland
-
Sport Injury Prevention Research CentreGeneral Electric; National Basketball AssociationCompletedTendinopathy | Sports Injuries in Children | Injury, Knee | Injury, AnkleCanada
-
Centre Hospitalier Universitaire, AmiensRecruitingQuality of Life | Pain | Lumbar Spine SurgeryFrance
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Trialbureau... and other collaboratorsRecruitingAdolescent Idiopathic ScoliosisNetherlands
-
University of IcelandMemorial Sloan Kettering Cancer Center; Landspitali University Hospital; deCODE... and other collaboratorsActive, not recruitingMonoclonal Gammopathy of Undetermined SignificanceIceland
-
Rennes University HospitalUnknown
-
Centre Hospitalier Universitaire DijonRecruitingMyocardial Infarction | Cerebrovascular AccidentsFrance
-
Rennes University HospitalMinistry of Health, FranceCompletedTelemedicine | Defibrillators, ImplantableFrance