Predictive Utility of a Short-term Improvement in Objectively Measured Physical Activity in Rheumatoid Arthritis (PUSIPA)

NCT06289114 | Recruiting

• 1 other identifier: S-20220005
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

SUMMARY Background: Several studies have shown physical activity (PA) to be inversely correlated to disease activity in rheumatoid arthritis (RA) patients. However, it is unclear whether improved PA leads to lower disease activity or if low disease activity predicts improved PA in rheumatoid arthritis patients. Furthermore, it is unknown how fibromyalgia (FM) affects this interaction. Objective(s): Our primary objective will be to compare the effect of an immediate improvement in physical activity after one week on the proportion of RA patients achieving low disease activity after 12 weeks of biological treatment. Furthermore, we will explore whether the presence of concomitant FM affects this clinical response (i.e., interaction between FM status and PA response). Design: A prospective cohort study in the form of a target-trial attempting to address a causal question comparing the outcome among the participants with an immediate improvement in physical activity, relative to individuals without. Setting and patients: Biologically naive RA patients initiating biological treatment are consecutively enrolled. PA is quantified by accelerometry one week prior to, one week after, and after 3 months of biological treatment. Sample size: 100 RA patients starting biological therapy is planned enrolled in the study. Measurements: RA patients will be divided into two groups depending on their improvement in physical activity after onset of biological treatment. The percentage of time spent in moderate-to-vigorously physical activity (MVPA) i.e., the percentage of time a patient is in motion \[walking, running, bicycling, or swimming\] is measured prior to, one week, and approximately 3 months after biological treatment onset, respectively. The MVPA ratio (MVPA After biological treatment/MVPA Before biological treatment) will divide patients enabling a contrast between two groups: Those with high improvement considering MVPA (after 1 week; the upper tertile of MVPA ratio of the sample) and those without. Treatment response (achieving a disease activity score \< 3.2) after approximately 3 months from baseline will be analyzed as the contrast between groups.

Conditions

Rheumatoid Arthritis; Fibromyalgia, Secondary; Fatigue; Physical Inactivity

Outcome Measures

Primary Outcomes (2)

• MVPA ratio before and after biological therapy

  Time spent in moderate-to-vigorously physical activity before and after biological therapy. Continous meassure will be performed during 1 week.

  at baseline, after 1 week and after 12 weeks from treatment initiation.

• Disease activity score (DAS)

  DAS score will be uptained at each visit (0-10, where 10 represent maximum disease activity)

  at baseline, after 1 week and after 12 weeks from treatment initiation.

Secondary Outcomes (2)

• Fibromyalgia

  at baseline, after 1 week and after 12 weeks from treatment initiation.

• Fatigue

  at baseline, after 1 week and after 12 weeks from treatment initiation.

Other Outcomes (1)

• Physical activity scores on questionnaire

  at baseline, after 1 week and after 12 weeks from treatment initiation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with RA (\> 18 years of age) who are to be treated with a biological agent.

You may qualify if:

• Patients with RA (\> 18 years of age)
• Patients who are to be treated with a biological agent
• Patients who can read and understand Danish

You may not qualify if:

• Patients who are physically impaired (patients depending on assistance devices for walking)
• Pregnancy
• Patients who have received corticosteroids two weeks prior to and during the period of the movement measurement
• Patients who by virtue of illiteracy or cognitive impairment, are unable to complete the questionnaire.

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

Esbjerg Hospital

Esbjerg, 6700, Denmark

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Fibromyalgia; Fatigue; Sedentary Behavior

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Philip R Lage-Hansen, MD

CONTACT

+4530114582; philip.rask.lage-hansen3@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)