A Randomised Controlled Trial Assessing the Effects of a Six-week Exercise Programme on Fitness, Inflammation and Cardiovascular Risk in Women With Rheumatoid Arthritis

Siobhan Graham1 site in 1 country25 target enrollmentStarted: May 1, 2016Last updated: January 19, 2017

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Siobhan Graham
Enrollment: 25
Locations: 1
Primary Endpoint: 200m Walk-test to estimate Cardiorespiratory fitness

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This study is investigating whether a six-week exercise training programme, designed for patients with Rheumatoid Arthritis, improves disease activity, inflammation, cardiorespiratory fitness, muscle strength, flexibility and risk factors for cardiovascular disease. Twenty four patients will be randomly assigned to an intervention or control group (n=12 in each group). The intervention group will will undertake a fully supervised structured exercise training programme, consisting of both aerobic and strength training exercise, taking the form of two 70-minute group fitness classes per week for six weeks. These participants will also undertake a 30-minute walk in their own time. The control group will continue to go about their normal daily activities. Measurements will be made before and after the intervention/control period, including assessments of disease activity (e.g., by gauging how swollen and tender patients' joints are using the Disease Activity Score(DAS) ) and assessments of fitness and/or physical functioning (e.g., 200 meter timed walk test, a strength test, a flexibility test, Health Assessment Questionnaire Disability Index (HAQDI)). Blood samples will also be collected from patients before and after the intervention/control period to measure markers of inflammation, such as C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR). The investigators will also measure other parameters that are linked to type II diabetes (e.g., fasting glucose concentration) and factors implicated in cardiovascular disease risk (e.g., lipid profile and resting blood pressure).

Detailed Description

Rheumatoid Arthritis (RA) is a multi-system autoimmune disease characterised by chronic inflammation (i.e., a persistent and inappropriate immune response). It primarily affects the joints, causing swelling, pain, reduced muscle strength and high biomarkers of inflammation such as C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). This immune response also results in accelerated atherosclerotic processes, decreased Bone Mineral Density (BMD) and damage to cartilage in the affected joints. Until the mid-1990s, patients with RA had traditionally been advised to avoid physical exercise, due to concerns it may result in progression of joint damage; hospital admission for bed rest was common practice. However, in the last 20 years, studies have shown that combined moderate-intensity aerobic exercise and strength training, can improve joint swelling, increase cardiorespiratory fitness and strength, without exacerbating pain or joint damage in patients with RA. Thus, the American College of Sports Medicine (ACSM) recommends that patients with RA walk or cycle for at least 30 minutes three times a week at a moderate intensity of 60% to 85% of maximum heart rate (HRmax) to improve cardiorespiratory fitness. The ACSM also recommends static or dynamic strength training of all large muscle groups twice weekly, performing three sets of 8-10 repetitions of 50% to 80% of one repetition maximum (1RM). While it is now established that exercise training can limit disease activity, and lower systemic inflammation, it is unclear whether short (e.g., six-weeks) and feasible exercise training programmes (e.g., two 70 minute sessions per week) elicit the same effects as the commonly employed interventions that are more demanding (e.g., 3-12 months; 3-5 sessions per week). In addition, it is unclear whether such a short intervention can modify other factors implicated in non-communicable disease, such as type II diabetes and cardiovascular risk (e.g., glucose control, lipid profile, blood pressure).

Objectives:

To examine if a six-week moderate intensity aerobic exercise and muscle strengthening programme:

Results in changes in disease activity.
Improves cardiorespiratory fitness, strength and flexibility.
Reduces disease related inflammatory markers.
Reduces blood pressure, improves lipid profile and improves glucose control.

Study Design:

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to 69 Years (Adult, Older Adult)
Sex: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

•Age 18-69
•Non-smokers
•Diagnosis of Rheumatoid Arthritis for greater than 12 months
•Stable Disease modifying medication for the preceding three months
•Functional capacity class I-II
•Able to use an exercise bicycle
•Willing to exercise twice-weekly on a fixed schedule
•Available for eight weeks between May and September 2016

Exclusion Criteria

•Cardiovascular disease (i.e. coronary heart disease, previous heart attack, angina, stroke or uncontrolled hypertension)
•Major psychiatric illness, such as schizophrenia or major depression
•A prosthetic hip or knee joint.

Arms & Interventions

Intervention group

Experimental

Participants, who have been randomly assigned to the intervention group, will take part in a six-week supervised exercise training programme. This programme takes place in a rehabilitation gymnasium. The exercise programme consists of two group sessions per week (scheduled for evenings, after typical working hours, approximately 12 patients per session). Each session lasts for approximately 70 minutes and includes a 5 minute warm up, 30 minutes of aerobic cycling exercise, 30 minutes of strength training, and a 5 minute cool down.

Participants will also perform a 30 minute walk each weekend as part of the intervention.

Intervention: Exercise Intervention (Behavioral)

Control group

No Intervention

Participants who have been randomly assigned to the control group will not undertake the exercise intervention. These participants are instructed to maintain their usual lifestyle.