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
Verified date | January 2017 |
Source | Belfast Health and Social Care Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 25 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria: - Female - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Musgrave Park Hospital, Belfast health and social care trust. | Belfast | County Down |
Lead Sponsor | Collaborator |
---|---|
Siobhan Graham | University of Bath |
United Kingdom,
ACSM 2010. American College of Sports Medicine's Resource Manual for Guidelines for Exercise Testing and Prescription. 6th Edition, 659-661.
Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Ménard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovský J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584. — View Citation
Crowson CS, Liao KP, Davis JM 3rd, Solomon DH, Matteson EL, Knutson KL, Hlatky MA, Gabriel SE. Rheumatoid arthritis and cardiovascular disease. Am Heart J. 2013 Oct;166(4):622-628.e1. doi: 10.1016/j.ahj.2013.07.010. Review. — View Citation
de Jong Z, Munneke M, Kroon HM, van Schaardenburg D, Dijkmans BA, Hazes JM, Vliet Vlieland TP. Long-term follow-up of a high-intensity exercise program in patients with rheumatoid arthritis. Clin Rheumatol. 2009 Jun;28(6):663-71. doi: 10.1007/s10067-009-1125-z. — View Citation
de Jong Z, Munneke M, Zwinderman AH, Kroon HM, Jansen A, Ronday KH, van Schaardenburg D, Dijkmans BA, Van den Ende CH, Breedveld FC, Vliet Vlieland TP, Hazes JM. Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial. Arthritis Rheum. 2003 Sep;48(9):2415-24. — View Citation
van den Ende CH, Breedveld FC, le Cessie S, Dijkmans BA, de Mug AW, Hazes JM. Effect of intensive exercise on patients with active rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2000 Aug;59(8):615-21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in DAS (Disease Activity Score) | DAS-28 uses the number of swollen joints, the number of tender joints, the C-reactive Protein level and the patient's global assessment of well-being, scored out of 100, to calculate the disease activity score at that point in time. Based on the American college of rheumatology (ACR) a change of minus 20 % the DAS-28 score is considered a moderate response. | Before and after six-week intervention (approximately 8 weeks) | |
Primary | 200m Walk-test to estimate Cardiorespiratory fitness | Time taken to complete the 200 metre walk test before and after six-week intervention. Measured in seconds. | Before and after six-week intervention (approximately 8 weeks) | |
Primary | Strength of quadriceps muscles | Using a Cybex dynamometer the investigators will measure the peak muscle torque of a concentric contraction of the quadriceps muscle. This is measured in Newtons metres (N. m) | Before and after six-week intervention(approximately 8 weeks) | |
Primary | Flexibility of hamstring muscles | Assessed using the Sit and Reach Test box. The patient is seated with feet flat against the sit and reach box. The patient then reaches their arms forward toward the top of the box which has a scale starting at zero centimetres at the participant's ankle up to 40 centimetres beyond the participant's ankle. Increased measurement corresponds to increased hamstring flexibility. Three attempts are recorded and the average measurement in centimetres is recorded. This estimates flexibility of hamstring muscles. | Before and after six-week intervention (approximately 8 weeks) | |
Primary | Strength of hamstring muscles | Using the Cybex dynamometer the investigators will measure the peak muscle torque of a concentric contraction of the hamstring muscles. This is measured in Newtons metres. | Before and after six-week intervention(approximately 8 weeks) | |
Primary | Blood pressure | Measured on the left arm of the patient using a sphygmomanometer. The patient will be seated for at least 15 minutes with the arm supported at the level of the precordium. Three measurements will be made and the average recorded in millimetres of mercury (mmHg) | Before and after six-week intervention (approximately 8 weeks) | |
Primary | Cardiovascular Risk Score | This is calculated using an algorithm call the Q-Risk2 which is validated for use in the United Kingdom. It uses blood pressure, cholesterol level, smoking status, age, body mass index,ethnicity, and presence of rheumatoid Arthritis, chronic kidney disease and family history of heart disease, to predict the ten year risk of cardiovascular disease | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | CRP (C-Reactive Protein) | Marker of inflammation assessed in serum. Measured in milligrams per litre (mg/litre) | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | ESR (Erythrocyte Sedimentation Rate) | Marker of inflammation. Units of measurement are millimetres per hour (mm/hour) | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | BMI (Body Mass Index) | The investigators will firstly measure the patient's weight in kilograms and the participant's height in metres. BMI is calculated by dividing the participant's weight by the participant's height squared. Units of measurement are kilograms per metre squared (kg/ m2) | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | Fasting glucose | Assessed after 12 hours fasting. Units of measurement are millimoles per litre (mmol/L) | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | HBA1C (Glycated Haemoglobin 1C) | Assessed 12 hours after fasting. Units of measurement are millimoles per mole (mmol/mol) | Before and after six-week intervention(approximately 8 weeks) | |
Secondary | Fasting total cholesterol | Assessed 12 hours after fasting. Measured in millimoles per litre (mmol/L) | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | Fasting HDL-Cholesterol | Assessed 12 hours after fasting. Measured in millimoles per litre (mmol/L) | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | Fasting LDL-Cholesterol | Assessed 12 hours after fasting. Measured in millimoles per litre (mmol/L) | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | Fasting Triglycerides | Assessed 12 hours after fasting. Measured in millimoles per litre (mmol/L) | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | HAQDI (Health Assessment Questionnaire Disability Index) | Qualitative assessment of functional capacity to assess ability to carry out activities of daily living | Before and after six-week intervention (approximately 8 weeks) | |
Secondary | The short form of the International Physical Activity Questionnaire (IPAQ) | An assessment of the type and quantity in hours and minutes of physical activity during the previous week. | Before and after six-week intervention (approximately 8 weeks) |
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