Rheumatoid Arthritis Clinical Trial
Official title:
Effectiveness of Community Based Physical Activity on Step Count and Sedentary Behaviour in Patients With Rheumatoid Arthritis Within the First Five Years of Diagnosis
Verified date | May 2017 |
Source | University of Glasgow |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall aim of this randomized control trial study is to investigate the effectiveness of a six-month, community based, pedometer supported, walking programme, along with an education programme incorporating behavioural change techniques on steps count and sedentary time, disease activity, functional capacity and cardiovascular risk of people within the first five years of being diagnosed with RA.
Status | Completed |
Enrollment | 76 |
Est. completion date | April 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Confirmed Rheumatoid Arthritis according to American College of Rheumatology (ACR)/ European League Against Rheumatism criteria (EULAR) 2010. - Diagnosed within the first five years of disease. - Willing and able to give written informed consent. - Age 18 years and over. Exclusion Criteria: - Patients will be excluded, if they suffer from severe hypertension, joint replacement in the previous 6 months, unstable cardiac conditions and other serious pathology which would affect their ability to take part in physical activity such as uncontrolled diabetes. - Pregnancy. - Unable to understand written and spoken English. - Cognitive impairment determined by the clinical judgment of the researcher. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Western Infimary | Glasgow | Glasgow, UK |
Lead Sponsor | Collaborator |
---|---|
University of Glasgow |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Physical activity will be assessed.( ActivPAL monitor and International Physical Activity Questionnaire (IPAQ)) | The measure is a composite. Objectively measured physical activity and sedentary behavior will be assessed using an ActivPAL activity monitor, which measures the posture and classifies daily living activity into periods spent sitting, lying, standing and stepping. An ActivPAL monitor will be used in assessment for 7 consecutive days to monitor individual physical activity, time spent sedentary and will also be used at each follow up assessment. The monitor will be attached to the participant's thigh at each assessment point and, following the seven day period. IPAQ is categorized into low, moderate and high physical activity. |
Baseline, 3, 6 months and one year | |
Secondary | Change in RA assessment from baseline to end of the study using (Disease activity A simplified Disease Activity Index (SDAI) and Rheumatoid Arthritis Quality of Life (RAQoL)) | The measure is a composite.A simplified Disease Activity Index (SDAI) will be used to assess clinical disease activity based. The SDAI score is based on joint tenderness, swelling, patient global score (0-10), provider global score (0-10) and C - reactive protein mg/dl. The RAQoL is a self-assessment questionnaire score originally developed in the UK and the Netherlands. It consists 30 items with a yes/no (1/0) response format. The overall score is the sum of individual item scores the sore range from0-30 and the higher the score the poorer the quality of life.The questionnaires will be completed, face to face, during the assessments. | baseline, 3, 6 months and one year | |
Secondary | change in RA assessment from baseline to the end of the study Functional ability (Six minute walk test (6MWT),Stanford Health Assessment in functional capacity Questionnaire (HAQ) and Hand grip strength ) | The measure is a composite.The participants will be asked to walk for a period of six minutes, at their own pace, along a straight, 30 m hallway. Participants will be asked to cover as much ground as possible in six minutes, but will be allowed to stop if required. The distance in meters will be recorded at the end of the six minutes. A Health Assessment Questionnaire will be used to measure the capacity to perform activities in daily life. The score ranges from 0-3, with the higher score (3) indicating more disability and the lowest score (0) indicating no physical disability.The hand grip test will be done while the participant is in a sitting position with shoulders adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral and wrist between 0 and 30° of extension. The test will be repeated 3 times with the dominant hand, and maximum reading will be taken. The questionnaires will be completed, face to face, during the assessments. |
baseline, 3, 6 months and one year | |
Secondary | change in Cardiovascular risk factors(Blood pressure will be measured,blood sample will be taken).Anthropometric variables Body mass index, waist circumference, waist hip ratio and waist height ratio. | The measure is a composite.Blood pressure will be measured. Routine clinical blood samples will also be taken in order to asses for lipids (e.g. total and HDL cholesterol and triglycerides), glucose, insulin, HbAlc, liver function (ALT, GGT, AST), inflammatory biomarkers (e.g. CRP), and NMR metabolomics profile (non- routine). | baseline, 3, 6 months and one year | |
Secondary | change in Dietary assessment(Dietary Instrument for Nutrition Education (DINE)) | The DINE method is a brief and inexpensive tool for diet assessment in primary care health promotion programmes.The DINE consists of questions regarding eating and drinking over the last 7 days, and scores are obtained for fatty and sugary food and fruit and vegetable intake.The questionnaires will be completed, face to face, during the assessments. | baseline, 3, 6 months and one year | |
Secondary | Change in Self-efficacy to Regulate Exercise | The Self-efficacy to Regulated Exercise questionnaire will be used, which is a reliable instrument with high internal consistency and satisfactory constructive validity (Kroll et al, 2007).The score ranges from 0-100 with the higher score (90-100) indicating high certainty and the lowest score (0) indicating cannot do.The questionnaires will be completed, face to face, during the assessments. | baseline, 3, 6 months and one year | |
Secondary | Change in Charlson Comorbidity Index | Charlson comorbidity index is a valid and reliable method of measuring comorbidity that can be used in clinical research. The score is reached by adding the comorbidity score to age score. The information will be taken from participant medical record. | baseline, 3, 6 months and one year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |