The Effects of a Six-week Exercise Programme Undertaken by Women With Rheumatoid Arthritis

NCT02819830 | Completed

• 1 other identifier: REC: 16/SS/0064
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis; Physical Activity

Keywords

Aerobic exercise; Strength training; Inflammation; cardiovascular disease

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (11)

• CRP (C-Reactive Protein)

  Before and after six-week intervention (approximately 8 weeks)

• ESR (Erythrocyte Sedimentation Rate)

  Before and after six-week intervention (approximately 8 weeks)

• BMI (Body Mass Index)

  Before and after six-week intervention (approximately 8 weeks)

• Fasting glucose

  Before and after six-week intervention (approximately 8 weeks)

• HBA1C (Glycated Haemoglobin 1C)

  Before and after six-week intervention(approximately 8 weeks)

Study Arms (2)

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.

Behavioral: Exercise Intervention

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.

Interventions

Exercise Intervention BEHAVIORAL

Combined strength and aerobic exercise

Intervention group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Siobhan Graham: lead
• University of Bath: collaborator

Study Sites (1)

Musgrave Park Hospital, Belfast health and social care trust.

Belfast, County Down, BT9 7JB, United Kingdom

Location

Related Publications (6)

• ACSM 2010. American College of Sports Medicine's Resource Manual for Guidelines for Exercise Testing and Prescription. 6th Edition, 659-661.

  BACKGROUND

• 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, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky 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.

  PMID: 20872595 BACKGROUND

• 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. Epub 2013 Aug 29.

  PMID: 24093840 BACKGROUND

• 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. Epub 2009 Feb 27.

  PMID: 19247575 BACKGROUND

• 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. doi: 10.1002/art.11216.

  PMID: 13130460 BACKGROUND

• 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. doi: 10.1136/ard.59.8.615.

  PMID: 10913058 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Motor Activity; Inflammation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James E Turner, BSc PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

• Claire Riddell, MD MB BCH

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General Practitioner

Study Record Dates

• First Submitted: June 25, 2016
• First Posted: June 30, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 19, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)