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.
ID
Bron
Verkorte titel
Aandoening
Rheumatoid Arthritis, Cardiovascular disease, Exercise therapy, Inflammation, Cardiorespiratory fitness, Reumatoïde Artritis, Cardiovasculaire
ziekte, Oefentherapie, Ontsteking,
Cardiorespiratoire fitheid
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome of the study is cardiorespiratory fitness assessed with a graded exercise tolerance test on an exercise bike (Lode, the
Netherlands).
Achtergrond van het onderzoek
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.
Objectives:
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).
Study design:
An experimental pre-posttest within-study design.
Study population:
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.
Doel van het onderzoek
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.
Onderzoeksopzet
before and after the intervention outcomes wil be assessed
Onderzoeksproduct en/of interventie
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)
Publiek
dr. Jan van Breemstraat 2
Amsterdam 1056 AB
The Netherlands
020-2421817
l.edelaar@reade.nl
Wetenschappelijk
dr. Jan van Breemstraat 2
Amsterdam 1056 AB
The Netherlands
020-2421817
l.edelaar@reade.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL6538 |
NTR-old | NTR6726 |
CCMO | NL 00000.000.00 METC |