Rheumatoid Arthritis Clinical Trial
Official title:
A Randomised Controlled Trial Assessing the Effects of a Six-week Exercise Programme on Fitness, Inflammation and Cardiovascular Risk in Women With Rheumatoid Arthritis
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).
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:
Twenty-four patients will be randomised to either the exercise intervention (n= 12) or the
control group (n = 12). The exercise intervention will consist of combined aerobic and
strength training group-exercise intervention lasting six weeks, with two classes per week.
All participants will undergo assessments to measure markers of inflammation, disease
activity, physical fitness, strength, flexibility and cardiovascular risk factors before and
after the six-week intervention.
Recruitment:
Female patients aged 18 to 69 years of age with RA attending Rheumatology outpatient clinics
at the Belfast and Social Health Care Trust hospitals will be invited to participate.
Patients satisfying the inclusion and exclusion criteria who would like to take part will
attend two appointments before being randomised to either the six-week exercise intervention
or the control group. Following the six-week intervention all patients will return for two
further appointments to repeat all measurements taken before the intervention.
Measurements before the six-week intervention.
- Experimental Visit One. This visit is scheduled between 08:00-09:00 (duration 1 hour).
Following written consent blood samples, blood pressure, anthropometry, joint
examination, questionnaires will be carried out. All patients, in both groups, will be
advised to arrive fasted with their last meal to have been eaten greater than 12 hours
before arrival. Patients should refrain from exercise during the 48 hours before, and
abstain from alcohol and caffeine for 24 hours.
- Experimental Visit Two. This visit is scheduled between 12:00-16:00 (duration 1 hour)
and will consist of a 200 metre walk test, a sit and reach flexibility test, and
strength test.
Measurements after the six-week intervention:
- Experimental Visit Three. This visit is scheduled between 08:00-09:00 (duration 1
hour). It is identical to visit one. Measurements include a blood sample, blood
pressure, anthropometry, joint examination, questionnaires. All participants in both
groups will be advised to arrive fasted with their last meal to have been eaten at
least 12 hours before arrival. Patients should refrain from exercise during the 48
hours before, and abstain from alcohol and caffeine for 24 hours.
- Experimental Visit Four. This visit is scheduled between 12:00-16:00 (duration 1 hour)
it is identical to visit two and consists of the 200 metre walk test, a sit and reach
flexibility test, and strength test.
Exercise Intervention:
The six-week exercise programme will comprise two 70-minute group exercise classes per week
(usually 12 patients per class). Classes will be fully supervised and will be conducted at a
fitness and rehabilitation gymnasium. Each class will consist of four parts (A-D, see
below). Participants will also be asked to go for a moderate intensity walk once a week for
30 minutes and maintain an exercise diary for all exercises including gym sessions.
A. Warm up and stretching for five minutes:
The warm-up will begin with standing and raising knees alternately for 30 seconds followed
by gentle stretching of all the large muscles groups: lumbar, quadriceps, hamstrings, groin,
pectorals, triceps, biceps, hands and feet muscles; stretching of each group will last for
30 seconds. Stretches will be modified for each patient and supportive props used where
necessary.
B. Aerobic exercise for 30 minutes:
Aerobic exercise will consist of 30 minutes cycling on a stationary cycle ergometer. This
will begin with a five-minute, low-intensity warm-up (low intensity is Heart Rate(HR) < 50%
of age predicted HRmaximum). Intensity will then increase to 60% HRmax for 20 minutes,
ending with a five-minute low intensity cool-down.
The exercise programme will be progressive, each week increasing in intensity by 5% of HRmax
up to 85% HRmax during the final week. Patients will wear a wrist and chest heart-rate
monitor, and will be advised when they have reached required intensity. This will be
recorded at each class in their exercise diary along with minutes cycled. Progression of
intensity will begin after week two to allow for familiarisation with the programme.
C. Strengthening exercises for 30 minutes:
This will consist of five exercises, working the large muscles of the upper limbs, lower
limbs and abdomen: leg extension, bench press, low row, modified abdominal crunch and wall
squat. Leg extension and low row will be performed on a pulley weights machine and bench
press using the multi-gym system.
One repetition maximum (RM) is the maximum weight in kilograms that can be lifted once and
no more. Each of these exercises will start with three sets of 8-10 repetitions at 60% of
1RM, progressing by 5% of 1RM each week. RM will be recalculated weekly after week two.
Modified abdominal crunch will begin by assessing the maximum number of crunches the patient
can perform to near exhaustion. The participants will then perform this number two more
times with a 90 second rest in between. After two weeks this will be progressed by
recalculating the number of crunches to near exhaustion each week.
The wall squat will start with assessment of the time the patient can hold the squat before
becoming fatigued. This will be repeated twice more, with a 90 second rest in between. After
two weeks this will be progressed by re-timing the wall squat until fatigue, each week
thereafter.
A record of all exercises performed, along with weights lifted, times, and heart rate will
be documented weekly by each patient in their record sheets.
D. Cool-down:
Five minutes of light stretching of all the large muscle groups and instructions on
performing moderate intensity walk each weekend. The cooI-down is identical to the warm-up.
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