The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients

NCT06295848 | Recruiting

• 1 other identifier: KayseriCH005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Rehabilitation; Rheumatoid Arthritis; Hypertension

Outcome Measures

Primary Outcomes (5)

• Framingham Risk Score(FRS)

  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

  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

  It is the gold standard for hypertension diagnosis and 24-hour blood pressure evaluation.

  0-week, 6-week,12-week,24-week

• DAS28

  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)

  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 Outcomes (4)

• The Six-Minute Walk Test (6MWT)

  0-week, 6-week,12-week,24-week

• The 36-Item Short Form Survey (SF-36)

  0-week, 6-week,12-week,24-week

• International Physical Activity Questionnaire (IPAQ) - Short Form

  0-week, 6-week,12-week,24-week

• Beck Depression Inventory (BDI)

  0-week, 6-week,12-week,24-week

Study Arms (2)

Cardiac Rehabilitation

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Exercise BEHAVIORAL

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.

Cardiac Rehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Health Sciences University, Kayseri Medicine Faculty

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

RECRUITING

Related Publications (16)

• Chauhan K, Jandu JS, Brent LH, Al-Dhahir MA. Rheumatoid Arthritis. 2023 May 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441999/

  PMID: 28723028 BACKGROUND

• Gibofsky A. Epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis: A Synopsis. Am J Manag Care. 2014 May;20(7 Suppl):S128-35.

  PMID: 25180621 BACKGROUND

• Almutairi K, Nossent J, Preen D, Keen H, Inderjeeth C. The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. Rheumatol Int. 2021 May;41(5):863-877. doi: 10.1007/s00296-020-04731-0. Epub 2020 Nov 11.

  PMID: 33175207 BACKGROUND

• Avina-Zubieta JA, Choi HK, Sadatsafavi M, Etminan M, Esdaile JM, Lacaille D. Risk of cardiovascular mortality in patients with rheumatoid arthritis: a meta-analysis of observational studies. Arthritis Rheum. 2008 Dec 15;59(12):1690-7. doi: 10.1002/art.24092.

  PMID: 19035419 BACKGROUND

• Sokka T, Abelson B, Pincus T. Mortality in rheumatoid arthritis: 2008 update. Clin Exp Rheumatol. 2008 Sep-Oct;26(5 Suppl 51):S35-61.

  PMID: 19026144 BACKGROUND

• Hadwen B, Stranges S, Barra L. Risk factors for hypertension in rheumatoid arthritis patients-A systematic review. Autoimmun Rev. 2021 Apr;20(4):102786. doi: 10.1016/j.autrev.2021.102786. Epub 2021 Feb 18.

  PMID: 33609791 BACKGROUND

• Anyfanti P, Gkaliagkousi E, Triantafyllou A, Koletsos N, Gavriilaki E, Galanopoulou V, Aslanidis S, Douma S. Hypertension in rheumatic diseases: prevalence, awareness, treatment, and control rates according to current hypertension guidelines. J Hum Hypertens. 2021 May;35(5):419-427. doi: 10.1038/s41371-020-0348-y. Epub 2020 May 7.

  PMID: 32382031 BACKGROUND

• Jagpal A, Navarro-Millan I. Cardiovascular co-morbidity in patients with rheumatoid arthritis: a narrative review of risk factors, cardiovascular risk assessment and treatment. BMC Rheumatol. 2018 Apr 11;2:10. doi: 10.1186/s41927-018-0014-y. eCollection 2018.

  PMID: 30886961 BACKGROUND

• Panoulas VF, Metsios GS, Pace AV, John H, Treharne GJ, Banks MJ, Kitas GD. Hypertension in rheumatoid arthritis. Rheumatology (Oxford). 2008 Sep;47(9):1286-98. doi: 10.1093/rheumatology/ken159. Epub 2008 May 8.

  PMID: 18467370 BACKGROUND

• Sahin AA, Ozben B, Sunbul M, Yagci I, Sayar N, Cincin A, Gurel E, Tigen K, Basaran Y. The effect of cardiac rehabilitation on blood pressure, and on left atrial and ventricular functions in hypertensive patients. J Clin Ultrasound. 2020 Dec 1:e22956. doi: 10.1002/jcu.22956. Online ahead of print.

  PMID: 33289108 BACKGROUND

• Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2002 Apr 2;136(7):493-503. doi: 10.7326/0003-4819-136-7-200204020-00006.

  PMID: 11926784 BACKGROUND

• Agca R, Heslinga SC, Rollefstad S, Heslinga M, McInnes IB, Peters MJ, Kvien TK, Dougados M, Radner H, Atzeni F, Primdahl J, Sodergren A, Wallberg Jonsson S, van Rompay J, Zabalan C, Pedersen TR, Jacobsson L, de Vlam K, Gonzalez-Gay MA, Semb AG, Kitas GD, Smulders YM, Szekanecz Z, Sattar N, Symmons DP, Nurmohamed MT. EULAR recommendations for cardiovascular disease risk management in patients with rheumatoid arthritis and other forms of inflammatory joint disorders: 2015/2016 update. Ann Rheum Dis. 2017 Jan;76(1):17-28. doi: 10.1136/annrheumdis-2016-209775. Epub 2016 Oct 3.

  PMID: 27697765 BACKGROUND

• Metsios GS, Stavropoulos-Kalinoglou A, Veldhuijzen van Zanten JJ, Treharne GJ, Panoulas VF, Douglas KM, Koutedakis Y, Kitas GD. Rheumatoid arthritis, cardiovascular disease and physical exercise: a systematic review. Rheumatology (Oxford). 2008 Mar;47(3):239-48. doi: 10.1093/rheumatology/kem260. Epub 2007 Nov 28.

  PMID: 18045810 BACKGROUND

• Peynirci Cersit H, Yagci I, Cersit S. The improvement in aerobic capacity, disease activity, and function in patients with rheumatoid arthritis following cardiac rehabilitation program: A single-center, controlled study. Turk J Phys Med Rehabil. 2019 Apr 26;66(2):121-133. doi: 10.5606/tftrd.2020.3250. eCollection 2020 Jun.

  PMID: 32760888 BACKGROUND

• Tessler J, Ahmed I, Bordoni B. Cardiac Rehabilitation. 2025 Mar 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537196/

  PMID: 30725881 BACKGROUND

• Balady GJ, Ades PA, Comoss P, Limacher M, Pina IL, Southard D, Williams MA, Bazzarre T. Core components of cardiac rehabilitation/secondary prevention programs: A statement for healthcare professionals from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation Writing Group. Circulation. 2000 Aug 29;102(9):1069-73. doi: 10.1161/01.cir.102.9.1069. No abstract available.

  PMID: 10961975 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Serap TOMRUK SÜTBEYAZ, PROFESSOR

  KAYSERİ CITY HOSPITAL

  STUDY DIRECTOR

• Abdurrahman KUTLUCA, MD

  Health Sciences University, Kayseri Medical Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HAVVA TALAY ÇALIŞ, PROFESSOR

CONTACT

+905326874541; htalaycalis@yahoo.com

Abdurrahman Kutluca, MD

CONTACT

00905416064166; abdurrahmankutluca@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: March 6, 2024
• Study Start: December 15, 2022
• Primary Completion: April 15, 2024
• Study Completion: June 15, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)