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…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the study is cardiorespiratory fitness assessed with a
graded exercise tolerance test on an exercise bike (Lode, the Netherlands).
Secondary outcome
Secondary outcomes are functional performance, CV risk factors and disease
activity.
Background summary
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.
Study objective
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.
Intervention
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).
Study burden and risks
The workload and risks for patients are
1. The number of blood tests: 2x (in case of recent test, no repetition of
blood draw)
2. The number of visits to the physician / researcher: 1x at rheumatologist and
rehabilitation physician, then 3 measurements in the clinimetrical laboratory
and 12 weeks of training at a physiotherapist.
3. Physical examination: Standard protocol at physician and 2-3 x testing of
cardiorespiratory fitness
4. The number and type of questionnaires and / or diaries: 4x general
questionnaires are taken and RA specific questionnaires.
5. The physical discomfort: during cardiorespiratory exercise tests fatigue
occurs.
6. Possible adverse side effects of treatment. Dosage of exercises is related
to exercise tests, which means that the risk of overload is low.
In the light of the workload and / or risks, the measurements and treatment,
the conduct of the investigation is justified.
Dr. Jan van Breemenstraat 2
Amsterdam 1056AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056AB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | In aanvraag |
CCMO | NL63018.048.17 |