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

This study is currently recruiting participants.
Verified October 2013 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Scott Grandy, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01534871
First received: February 10, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of a 12-week Cardiovascular Rehabilitation Exercise Program on Inflammatory Markers and Traditional Coronary Artery Disease Risk Factors in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Framingham risk score [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
    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.

  • Levels of systemic inflammation [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
    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).

  • Severity of rheumatoid arthritis [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
    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 one acute phase measure (blood test for c-reactive protein).


Secondary Outcome Measures:
  • Weight [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
  • Waist girth [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
    Waist girth will be measured at the level of the superior border of the iliac crest.

  • Resting heart rate [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
  • Resting blood pressure [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
  • Aerobic fitness [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
    Aerobic fitness will be determined based a graded exercise test (Bruce treadmill protocol) where speed and inclination of the treadmill increase every 3 minutes. The subject will be asked to exercise to volitional fatigue. Cardiac function will be monitored with a 12 lead ECG to determine if there is any evidence of cardiac disease (e.g. arrhythmia). Predictive equations developed for men and women will be used to calculate the subject's peak oxygen uptake.

  • Physical activity level [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
    Physical activity will be measured using the long form of the International Physical Activity Questionnaire. This questionnaire is suitable for use with clinical populations and has been used previously to quantify physical activity levels in rheumatoid arthritis patients.

  • Functional ability [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
    Functional status will be assessed using the short form of the Health Assessment Questionnaire (HAQ). This is a self report questionnaire that is comprised of the HAQ disability index, HAQ patient global health status and the pain visual analog scale.

  • Smoking history [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
    Subjects will be asked whether they are currently a smoker or if they have smoked in the past 5 years.

  • Alcohol consumption [ Time Frame: Final measure week-13 ] [ Designated as safety issue: No ]
    Subjects will be asked to quantify there average weekly alcohol intake.


Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
Subjects enrolled in the exercise arm will receive the study intervention.
Behavioral: Exercise
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.
No Intervention: Control
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534871

Contacts
Contact: Volodko Bakowsky, MD 902-473-3818 volodko.bakowsky@cdha.nshealth.ca
Contact: Scott A Grandy, PhD 902-494-1145 grandy@dal.ca

Locations
Canada, Nova Scotia
Nova Scotia Rehabilitation Centre Recruiting
Halifax, Nova Scotia, Canada
Contact: Volodko Bakowsky, MD    902-473-3818    volodko.bakowsky@cdha.nshealth.ca   
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Nicholas Giacomantonio, MD Capital District Health Authority, Canada
Study Director: Scott A Grandy, PhD Dalhousie University
  More Information

No publications provided

Responsible Party: Scott Grandy, School of Health & Human Performance, Dalhousie University, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01534871     History of Changes
Other Study ID Numbers: CDHA_NB_SG-2012
Study First Received: February 10, 2012
Last Updated: October 9, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
Cardiac rehabilitation
Exercise
Systemic inflammation
Cardiovascular disease risk

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Cardiovascular Diseases
Coronary Artery Disease
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014