|- candidate number||27967|
|- NTR Number||NTR6726|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-sep-2017|
|- Secondary IDs||NL 00000.000.00 METC |
|- Public Title||Exercise in patients with Rheumatoid Arthritis and Cardiovascular risks|
|- Scientific Title||The effect of exercise on cardiorespiratory fitness in patients with Rheumatoid Arthritis and
|- ACRONYM||the eRAC study|
|- hypothesis||The overall hypothesis is that the developed exercise therapy program is feasible, safe and improves cardiorespiratory fitness, functional performance, reduces CV risk factors and disease activity in patients with RA and high CV risk.|
|- Healt Condition(s) or Problem(s) studied||Cardiovascular disease, Rheumatoid arthritis, Inflammation, Cardiorespiratory fitness|
|- Inclusion criteria||Diagnosis of RA fulfilling the ACR/EULAR classification criteria, high 10-year CV risk (≥20%) calculated with the Dutch SCORE table, age >20 and <80 years
|- Exclusion criteria||Comorbidity which severely affects functional ability (CIRS≥2), K&L grading of ≥3 for hip and/or knee OA, contra-indication for exercises according to the ACSM guideline (Durnstine 2009) i.e., progressive increase in heart failure symptoms, myocardial infarction less than 3 months before the start of the training program, severe ischemia of the cardiac muscle upon exertion, respiratory frequency of more than 30 breaths per minute and heart rate at rest >110 bpm, insufficient control of the Dutch language and/or cognitive problems.
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-okt-2017|
|- planned closingdate||1-okt-2019|
|- Target number of participants||30|
|- Interventions||The exercise therapy program will include exercises that are primarily aimed at improving cardiorespiratory fitness and functional performance in RA patients. Frequency, intensity, time, type and progression of the exercises will be performed according to the ACSM guideline (Durnstine 2009)|
|- Primary outcome||Primary outcome of the study is cardiorespiratory fitness assessed with a graded exercise tolerance test on an exercise bike (Lode, the
|- Secondary outcome||Secondary outcomes are functional performance, CV risk factors and disease activity.
|- Timepoints||before and after the intervention outcomes wil be assessed|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Lisa Edelaar|
|- CONTACT for SCIENTIFIC QUERIES||Dr Martin Van der Esch|
|- Sponsor/Initiator ||Reade Center for Rehabilitation and Rheumatology|
(Source(s) of Monetary or Material Support)
|Reade Center for Rehabilitation and Rheumatology|
|- Publications||Journals of rheumatology|
|- Brief summary||Rationale: |
Rheumatoid arthritis (RA) is associated with increased overall mortality compared to the general population, with cardiovascular diseases (CVD) as one of the main causes. The optimization of management of CV risk in RA patients is an important aim in the treatment. Active counseling is indispensable, including also attention to exercise, particularly in RA patients with a high CV risk, defined as a 10-year CV risk of 20% or higher. Physical exercise for these patients is necessary and challenging since professionals should take multiple factors into account, such as comorbid conditions related to CV risk (e.g. hypertension, diabetes mellitus and obesity). However, the effects of exercise therapy on CV risk in RA patients are unknown and the required intensity is also unknown.
The first aim of the present study is to develop a tailor-made exercise therapy program for these complex patients. The second aim is to evaluate the effect of exercise therapy in a pilot study on cardiorespiratory fitness and several secondary outcomes (i.e. safety, functional performance, CV risk factors, and disease activity).
An experimental pre-posttest within-study design.
Study population: 30 consecutive patients with RA recruited from an existing RA cohort with known risk factors.
Main study parameters/endpoints:
Primary outcome of the study is cardiorespiratory fitness assessed with a graded exercise tolerance test, either on a treadmill or an exercise bike (Lode, the Netherlands).
Secondary outcomes are functional performance, CV risk factors and disease activity.
|- Main changes (audit trail)|
|- RECORD||29-sep-2017 - 15-okt-2017|