The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients (CARDIRA)

March 27, 2024 updated by: Havva Talay Çalış, Kayseri City Hospital

The Effects of 6-week Cardiac Rehabilitation Programme on Cardiovascular Disease Risk, Systolic and Diastolic Blood Pressure and Disease Activity in Hypertensive Rheumatoid Arthritis Patients : A Randomised Controlled Trial

The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment.

Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rheumatoid arthritis (RA) is a chronic systemic auto-immune disease characterized by inflammation and structural damage in synovial joints, but also has extra-articular involvements such as the cardiovascular system. RA patients have higher mortality rates than the general population, and approximately half of premature deaths are due to cardiovascular comorbidities. Traditional risk factors, especially hypertension (HTN), play a key role in the development of cardiovascular diseases (CVD).

In chronic inflammatory diseases such as RA, autoimmunity is a cause of HTN as well as a result of physical damage to the vascular wall. Mild blood pressure elevation caused by specific HTN triggers such as salt retention, angiotensin-II or genetic susceptibility leads to neoantigen release through tissue damage. These neoantigens are recognized by antigen-presenting cells and lead to the differentiation of CD4+ naïve-T lymphocytes into Th1 and Th17 cells. IL-17 and IFN-γ expression causes local inflammation in the vascular wall, endothelial dysfunction, and arterial stiffness. Thus, HTN causes an increase in CVD risk through a common pathogenesis mechanism with RA.

European League Against Rheumatism (EULAR) recommendations emphasize that rheumatologists should be responsible for CVD risk management in RA. However, both RA and HTN treatment is generally administered pharmacologically without focusing on CVD risk. Patients may be recommended regular exercise and lifestyle changes according to EULAR recommendation guide for CVD risk management. One possible intervention that could be used to decrease CVD risk caused by both diseases is cardiac rehabilitation (CR) program in which regular exercise is one of the main components. But RA patients, especially those with cardiovascular comorbidities, are rarely referred to the CR program.

This study will help to clarify the effects of the CR program added to the pharmacological treatment of these patients on cardiovascular mortality risk (Framingham risk score and QRISK-3 score), blood pressure (24-Hour holter monitoring), disease activity (DAS28-CRP), aerobic capacity (VO2max), quality of life (36-Item Short Form Survey) and psychological state (Beck depression inventory).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Kocasinan
      • Kayseri, Kocasinan, Turkey, 38080
        • Recruiting
        • Health Sciences University, Kayseri Medicine Faculty
        • Contact:
          • Professor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients diagnosed with RA according to ACR/EULAR 2010 criteria
  2. Taking regular treatment for at least 1 month according to ACR/EULAR guidelines
  3. Patients diagnosed with HT according to the 2018 European Society of Hypertension and European Society of Cardiology (ESH/ESC) guideline

Exclusion Criteria:

  1. Refusing to participate in the program
  2. Severe mental disorder
  3. Neurological disease or deformity in the lower extremity that would prevent the patient from using the treadmill.
  4. High-risk unstable angina and all acute cardiac diseases (acute myocardial infarction, acute endocarditis, myocarditis or pericarditis)
  5. Uncontrolled HT, Diabetes, cardiac arrhythmia and heart failure
  6. Symptomatic severe aortic stenosis
  7. Acute pulmonary embolism or pulmonary infarction and severe pulmonary hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac Rehabilitation
The CR group will receive training for CVD and HT once a week, along with a rehabilitation program consisting of aerobic, resistance, flexibility and stretching exercises 3 days a week for 6 weeks.
Behavioral: Exercise
An individual program will be organized for each patient according to the exercise test result. Since the patients have both arthritis and HTN, aerobic exercises will be given at moderate intensity (40-60% VO2 reserve) according to ACMS recommendations. Xrcise Runner Med treadmill and Xrcise Care 2.5.8.3 software will be used for aerobic exercises. Resistant exercises will be given under the supervision of a physiotherapist, calculating 1 repetitation maximum (1-RM) in the main muscle groups.Patients will perform isotonic exercises with 3 sets of 15 repetitions with a resistance of 60% of 1-RM. The education sessions will be conducted by a multidisciplinary team of health professionals (nurse, physiotherapist and dietician) under the leadership of a clinician experienced in CR. Education topics will consist of 60-minute sessions covering heart-healthy eating, setting health-related goal, exercise, diet, healthy weight loss, smoking cessation, and stress/coping.
No Intervention: Control
Control group will receive treatment for their RA that is considered standard of care treatment (e.g. pharmacotherapy), but will not be participated in the CR program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Framingham Risk Score(FRS)
Time Frame: 0-week, 6-week,12-week,24-week
It is a common tool used to assess a patient's risk level of cardiovascular disease over the next 10 years. There are six coronary risk factors in the FRS calculation, including age, gender, total cholesterol, HDL cholesterol, smoking and systolic blood pressure. 10-year cardiovascular risk score can be derived as a percentage. Higher values indicate a worse, lower values indicate a better outcome.
0-week, 6-week,12-week,24-week
QRISK-3 Risk Score
Time Frame: 0-week, 6-week,12-week,24-week
It predicts a patient's risk of developing cardiovascular disease in the next 10 years. It includes many of the traditional risk factors featured in Framingham (such as age, gender, cholesterol/HDL ratio, blood pressure, diabetes and smoking status), but also includes important additional risk factors. 10-year cardiovascular risk score can be derived as a percentage. Higher values indicate a worse, lower values indicate a better outcome.
0-week, 6-week,12-week,24-week
24-Hour Ambulatory Blood Pressure
Time Frame: 0-week, 6-week,12-week,24-week
It is the gold standard for hypertension diagnosis and 24-hour blood pressure evaluation.
0-week, 6-week,12-week,24-week
DAS28
Time Frame: 0-week, 6-week,12-week,24-week
Rheumatoid arthritis severity will be determined using DAS28 score. The DAS28 score ranges score between 0 and 10, a larger number indicating more active disease. When using the score to assess response to treatment, a DAS-28 score reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement. The score <2.6 suggests disease remission.
0-week, 6-week,12-week,24-week
Maximal oxygen consumption (VO2max)
Time Frame: 0-week, 6-week,12-week,24-week
VO2 max is the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min). VO2 max is an objective measurement of cardiorespiratory capacity. Higher values indicate a worse, lower values indicate a better outcome.
0-week, 6-week,12-week,24-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Six-Minute Walk Test (6MWT)
Time Frame: 0-week, 6-week,12-week,24-week
The Six-Minute Walk Test is a submaximal field test used to monitor exercise capacity and treatment effectiveness in cardiac rehabilitation.
0-week, 6-week,12-week,24-week
The 36-Item Short Form Survey (SF-36)
Time Frame: 0-week, 6-week,12-week,24-week
Quality of life will be assessed using the short form of the 36-Item short form survey (SF-36). The SF-36 covers eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
0-week, 6-week,12-week,24-week
Beck Depression Inventory (BDI)
Time Frame: 0-week, 6-week,12-week,24-week
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.
0-week, 6-week,12-week,24-week
International Physical Activity Questionnaire (IPAQ) - Short Form
Time Frame: 0-week, 6-week,12-week,24-week
The IPAQ short form encompasses questions regarding time spent on walking, moderate-intensity, and high-intensity physical activities besides sitting. The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. Total physical activity can be computed as the sum of walking + moderate intensity + high intensity MET-min/week scores. Higher values indicate a worse, lower values indicate a better outcome. There are three levels of physical activity suggested for classifying patients based on total weekly MET score: low, moderate and high. The "minutes" of sitting reported by the IPAQ are asessed independtly and reflect sedentary behaviour measurements.
0-week, 6-week,12-week,24-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri City Hospital

Investigators

  • Study Director: Serap TOMRUK SÜTBEYAZ, PROFESSOR, Kayseri City Hospital
  • Principal Investigator: Abdurrahman KUTLUCA, MD, Health Sciences University, Kayseri Medical Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KayseriCH005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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