|- candidate number||7811|
|- NTR Number||NTR2240|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-mrt-2010|
|- Secondary IDs||NL22049.058.08 CCMO|
|- Public Title||Motivational Interviewing for promoting physical activity in patients with Rheumatoid Arthritis.|
|- Scientific Title||The use of Motivational Interviewing to promote physical activity in patients with RA.|
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis|
|- Inclusion criteria||1. Patients are recruted in the Leiden University Medical Center, the rheumatology outpatient clinic;|
2. Patients with RA who do not fullfill the Dutch public recommendations for physical activity (5 times weekly moderately physical active during 30 minutes).
|- Exclusion criteria||Patients who are not capable to be physically active due to co-morbidity.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2010|
|- planned closingdate||1-feb-2011|
|- Target number of participants||120|
|- Interventions||Motivational Interviewing and Self-regulation group (one session per week): |
1. 1 groupsession with regard to physical activity (why it is important, health benefits and how to become physically active) to provided by a physical therapist to stimulate that patients become more physically active in daily live;
2. 1 individual session with a trained physical therapist (motivational interviewing) to increase the internal motivation of the patient;
3. 2 individual sessions with a trained clinical nurse specialist (self-regulation) to increase the patient's selfregulation skills;
4. 2 phonecalls by the trained clinical nurse specialist.
1. 1 groupsession with regard to physical activity (why it is important, health benefits and how to become physically active)provided by a physical therapist (same as intervention group) to stimulate that patients become more physically active in daily live.
|- Primary outcome||1. Physical activity (SQUASH);|
2. Amount of selfregulation (e.g. motivation) (TRSQ);
3. Selfregulationskills with regard to physical activity (HCCQ).
|- Secondary outcome||1. Disease activity (RADAI);|
2. Physical and mental status (RAND-36);
3. Anxiety, depression, somatic complaints and sleeping disorders (SCL-90);
4. Fatigue (CIS-20).
|- Timepoints||1. Baseline (all outcome measures);|
2. After 6 weeks (all outcome measures);
3. After 20 weeks (all outcome measures);
4. After 52 weeks (all outcome measures).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| E.J. Hurkmans|
|- CONTACT for SCIENTIFIC QUERIES|| T.P.M. Vliet Vlieland|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Rheumatology|
(Source(s) of Monetary or Material Support)
|Vrienden van Sole Mio|
|- Brief summary||In the past few years various initiatives with concern to promoting physical activity have been developed. In many studies it appeared that the participants had troubles persisting the physical activity program long term. Adding Motivational Interviewing (MI) and Self-regulation, aimed at a behavioral change, to a physical activity program could perhaps stimulate more physical activity (mainly long term).
The study concern a randomized controled trial among 120 patients with RA who are physically inactive (do not fulfill the Dutch Public Health Recommendation for physical activity; 5x weekly 30 minutes moderate/intensive physical activity) and who do not have any contra-indications for physical activity.
All RA patients with recieve information with regard to physical activity by a general physical therapist.
Half of these RA patients will further receive one MI session with a trained physical therapist and 2 self-regulation session with a trained clinical nurse specialist and two follow-up phone calls by the same clinical nurse specialist.
Main aim is to increase the physical activity level of RA patients and maintain this physical activity level long-term.
|- Main changes (audit trail)|
|- RECORD||3-mrt-2010 - 21-mrt-2010|