Effects of Aerobic Exercise in Rheumatoid Arthritis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorKutahya Health Sciences University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with RA according to ACR/EULAR 2010 criteria

Female patients aged 30-70 years

Low disease activity (DAS-28 < 3.2)

Voluntary participation

Disqualifiers

Cardiovascular diseases (CAD, heart failure, etc.)

Respiratory diseases

Neurological disorders

BMI > 35

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Medical Care (SMC)

    Other intervention

    Standard medical treatment

  • Patient Education

    Other intervention

    Patient education

  • Aerobic Exercise Group

    Other intervention

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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 2 interventions
Group B: Aerobic Exercise GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and at the end of 6 weeks (42th day)
2

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.

Time frame
Baseline and at the end of 6 weeks (42th day)
3

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.

Time frame
Baseline and at the end of 6 weeks (42th day)
4

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.

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

Secondary outcomes

1

Beck Depression Inventory (BDI)

BDI is a 21-item self-reported questionnaire assessing depressive symptoms. Scores range from 0 to 63, with higher scores indicating more severe depression.

Time frame
Baseline and at the end of 6 weeks (42th day)
2

Fatigue Severity Scale (FSS)

FSS is a 9-item scale assessing fatigue severity using Likert-type responses. Higher scores indicate greater fatigue severity.

Time frame
Baseline and after 6 weeks
3

Visual analogue Scale for pain

Pain intensity is measured on a 10 cm visual analog scale, where 0 indicates no pain and 10 indicates worst possible pain.

Time frame
Baseline and at the end of 6th week (42th day)
4

Disease Activity Score-28 (DAS-28)

DAS-28 is a composite index including tender/swollen joint count, ESR or CRP levels, and patient global assessment. Lower scores indicate lower disease activity.

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

Other outcomes

Sponsors and contacts

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