The Effects of Cardiac Rehabilitation on Cardiovascular Disease Risk in Rheumatoid Arthritis Patients

NCT01534871 | Completed

• 1 other identifier: CDHA_NB_SG-2012
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects approximately 1% of all Canadians. RA is associated with a higher rate of disease and death as well as a decreased life expectancy. Changes in death rates and life expectancy are mainly the result of an increased frequency of cardiovascular disease (CVD). The increase in CVD frequency is primarily attributable to accelerated atherosclerosis. It is believed that elevated levels of inflammation, which are characteristic of RA, play a key role in accelerated rate of CVD in RA patients. Thus, inflammation is considered a primary risk factor for CVD in RA patients. Interestingly, despite a better understanding of the relationship between RA and CVD and improved treatment for RA patients the death rate in RA population continues to increase. Thus, there is an immediate need to develop treatment strategies to reduce the risk of CVD associated with inflammation in the RA population. Exercise is commonly used to reduce the risk of CVD. Preventative exercise programs are often offered as part of cardiac rehabilitation (CR) programs. These programs help patients modify CVD risk factors, improve physical capacity and decrease CVD risk. Studies also suggest that CR programs decrease levels of inflammation. Since RA patients have an elevated risk for CVD, which is primarily attributed to increased levels of inflammation, they are prime candidates for CR programs. However, RA patients are very rarely referred to CR programs. Thus, there is a lack of information regarding the effects of CR on RA patients. Thus studies are needed to determine whether CR modifies levels of inflammation and decreases CVD risk in RA patients. Therefore, the purpose of this study is to determine the effects of a 12-week standardized cardiac rehabilitation exercise program on systemic inflammation and CVD risk in individuals with RA. Specifically, this study will characterize the effects of a community based CR exercise program on systemic markers of inflammation (proinflammatory cytokines) and global CVD risk (Framingham risk profile) as well as the therapeutic effects of CR exercise on the severity of RA. This study will help to clarify the mechanism(s) by which exercise impacts CVD risk in patients with inflammatory disease. In addition, the study will show how CR may benefit patients with inflammatory disease with respect to their ability to exercise, global risk for cardiovascular disease and quality of life.

Conditions

Rheumatoid Arthritis

Keywords

Cardiac rehabilitation; Exercise; Systemic inflammation; Cardiovascular disease risk

Outcome Measures

Primary Outcomes (3)

• Framingham risk score

  Equation used to predict global coronary heart disease risk. Factors used in the equation to predict risk include age, total cholesterol or LDL cholesterol, HDL cholesterol, blood pressure, history of diabetes and smoking history.

  Final measure week-13

• Levels of systemic inflammation

  Blood samples will be collected from the subjects and used to to quantify serum levels of proinflammatory cytokines (IL-1 alpha and beta, IL-6, IL-17 and TNF alpha) and anti-inflammatory cytokines (IL-4, IL-10).

  Final measure week-13

• Severity of rheumatoid arthritis

  Rheumatoid arthritis severity will be determined using the American College of Rheumatology (ACR) response score. The ACR is a composite score based on 7 measures: 3 by an assessor (swollen joint, tender joint count and physician global status), 3 by the patient (function, pain and global status) and blood work to measure rheumatoid factor (RF), anti-citrullinated protein antibodies (ACAP), c-reactive protein (CRP), and erythrocyte sedimentation rate (ESR)).

  Final measure week-13

Secondary Outcomes (10)

• Weight

  Final measure week-13

• Waist girth

  Final measure week-13

• Resting heart rate

  Final measure week-13

• Resting blood pressure

  Final measure week-13

• Lipid profile

  Final measure week-13

Study Arms (2)

Exercise

EXPERIMENTAL

Subjects enrolled in the exercise arm will receive the study intervention.

Behavioral: Exercise

Control

NO INTERVENTION

Subjects in the control arm will receive standard of care (e.g. medication and medical supervision) for rheumatoid arthritis. These subjects will not participate in the exercise intervention.

Interventions

Exercise BEHAVIORAL

Subjects will be enrolled in a 12-week community cardiac rehabilitation program. The program consists of two one hour exercise sessions per week and one one hour education session per week. For the exercise sessions the subjects will perform aerobic exercise at 60-80% of heart rate reserve. Education sessions will cover heart healthy eating, setting health-related goals, exercise, nutrition, healthy weight, medication, smoking cessation and stress/coping.

Exercise

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only those patients that 1) have RA fulfilling the American College of Rheumatology criteria, 2) have two or more swollen joints, 3) are receiving stable pharmacotherapy (defined as greater than 3 months of unchanged antirheumatic drugs and greater than 1 month of unchanged nonsteroidal anti-inflammatory drugs), 4) have moderate risk of CVD as identified by the Framingham risk score, 5) are able to walk on treadmill or cycle on a stationary bike for 15 minutes and 6) are able to attend the Community Cardiovascular Hearts in Motion program (held in the Halifax Regional Municipality).

You may not qualify if:

• Patients that are 1) diabetic, 2) have known coronary, cerebral or peripheral artery disease, 3) taking statins, or 4) have one or more arthroplasties of weight bearing joints will not be eligible to participate in the study.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Rehabilitation Centre

Halifax, Nova Scotia, Canada

Location

Related Publications (1)

• Heinze-Milne S, Bakowsky V, Giacomantonio N, Grandy SA. Effects of a 12-week cardiovascular rehabilitation programme on systemic inflammation and traditional coronary artery disease risk factors in patients with rheumatoid arthritis (CARDIA trial): a randomised controlled trial. BMJ Open. 2017 Dec 22;7(12):e018540. doi: 10.1136/bmjopen-2017-018540.

  PMID: 29275344 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Motor Activity

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; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Nicholas Giacomantonio, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

• Scott A Grandy, PhD

  Dalhousie University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 17, 2012
• Study Start: October 2, 2013
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)