NCT07504887

Brief Summary

This study aims to evaluate the effects of aerobic exercise therapy on quality of life, functional capacity, mood, and fatigue in patients with rheumatoid arthritis. Additionally, the study investigates the impact of aerobic exercise on inflammatory markers, pain, and disease activity.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

March 22, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 22, 2026

Last Update Submit

March 26, 2026

Conditions

Rheumatic DiseasesRheumatic Disorder

Keywords

RHEUMATIC DISEASERHEUMATIC ARTRITPAINPHYSICAL MEDICINE AND REHABILITATION

Outcome Measures

Primary Outcomes (4)

  • Rheumatoid Arthritis Quality of Life Questionnaire

    RAQoL is a disease-specific instrument consisting of 30 items scored as yes/no. Total scores range from 0 to 30, with higher scores indicating poorer quality of life. The Turkish version has established validity and reliability.

    Baseline and at the end of 6 weeks (42th day)

  • Health Assessment Questionnaire (HAQ)

    HAQ evaluates functional ability in daily living activities using 20 items. Each item is scored from 0 (no difficulty) to 3 (unable to perform). The final score is calculated as the average of item scores, ranging from 0 to 3, with higher scores indicating worse functional status.

    Baseline and at the end of 6 weeks (42th day)

  • Functional Capacity (Cardiopulmonary Fitness)

    VO₂ max (mL/kg/min) is measured using cardiopulmonary exercise testing (CPET) on a cycle ergometer. It is considered the gold standard for assessing aerobic capacity.

    Baseline and at the end of 6 weeks (42th day)

  • 6-Minute Walk Test (6MWT)

    The 6MWT evaluates submaximal exercise capacity. Participants are instructed to walk as far as possible within 6 minutes on a 30-meter corridor. Total walking distance (meters) is recorded. Higher distances indicate better functional capacity.

    Baseline and at the end of 6th week (42th day)

Secondary Outcomes (6)

  • Beck Depression Inventory (BDI)

    Baseline and at the end of 6 weeks (42th day)

  • Fatigue Severity Scale (FSS)

    Baseline and after 6 weeks

  • Visual analogue Scale for pain

    Baseline and at the end of 6th week (42th day)

  • Disease Activity Score-28 (DAS-28)

    Baseline and at the end of 6 weeks (42th day)

  • Inflammatory Markers

    Baseline and at the end of 6 weeks (42th day)

  • +1 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standard medical treatment Patient education

Other: Standard Medical Care (SMC)Other: Patient Education

Aerobic Exercise Group

EXPERIMENTAL

Standard medical treatment Patient education Aerobic exercise program

Other: Standard Medical Care (SMC)Other: Patient EducationOther: Aerobic Exercise Group

Interventions

Patient EducationOTHER

Patient education

Aerobic Exercise GroupControl Group
Aerobic Exercise GroupOTHER

Frequency: 5 days/week Duration: 6 weeks (30 sessions) Exercise intensity: 50-70% of Wmax Includes warm-up, aerobic phase, and cool-down

Aerobic Exercise Group
Standard Medical Care (SMC)OTHER

Standard medical treatment

Aerobic Exercise GroupControl Group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with RA according to ACR/EULAR 2010 criteria
  • Female patients aged 30-70 years
  • Low disease activity (DAS-28 \< 3.2)
  • Voluntary participation

You may not qualify if:

  • Cardiovascular diseases (CAD, heart failure, etc.)
  • Respiratory diseases
  • Neurological disorders
  • BMI \> 35
  • Malignancy
  • Pregnancy or breastfeeding
  • Recent medication change (last 3 months)
  • Musculoskeletal conditions preventing exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rheumatic DiseasesPain

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Vural KAVUNCU, Prof. Dr.

CONTACT

002742600043vural.kavuncu@ksbu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

March 22, 2026

First Posted

April 1, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)