Contact information
Type
Scientific
Primary contact
Prof Mart van de Laar
ORCID ID
Contact details
University of Twente
Institute for Behavioural Research
Department of Psychology and Communication of Health Risk (PCHR)
P.O. Box 217
Enschede
7500 AE
Netherlands
+31 (0)53 489 2398
m.a.f.j.vandelaar@utwente.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DAPPER-study: Disabled Arthritis Patients Post-hospitalisation Exercise Recovery/Rehabilitation
Study hypothesis
1. Three weeks of intensive training immediately after hospital discharge improves the functional ability, mobility, quality of life in patients with arthritis on the short term and on the long term.
2. Over a period of one year the total cost of the intensive training group are equal or lower to the usual care associated with better effectiveness.
3. The arm ergometer is a valid and reliable measuring device to measure the aerobic condition with the use of the Åstrand Rhyming test.
Ethics approval
The trial was reviewed and accepted by the certified medical ethical commission (METC) of the Medisch Spectrum Twente in May 2002 (ref: P02-023)
Study design
The DAPPER study is a randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Rheumatoid arthritis and Osteoarthritis
Intervention
Directly following hospital discharge the patients of this study design recieved Intensive Exercise Therapy (IET) or Usual Care (UC).
The IET group were referred to a dedicated convalescent hotel. The hotel facilities and professional care for disabled people were offered for three-weeks. Thereafter, the IET group received regular care only. During their three week stay patients were trained twice a day by physical therapists, for 75 minutes per session. The goals of the training were improvement of range of motion, muscle strength, aerobic capacity and activities of daily life. The therapy sessions were given individually as well as in groups. In the first two weeks, treatment focused on individual limitations (range of motion, strength, balance, aerobic capacity and simple functionality). Aerobic capacity was trained daily on a sub maximal level. Hydrotherapy was applied after sufficient wound healing. During the third week, the training was focused on the functional capacities as prioritised by the patient. A group education program was given twice a week. This program was based on the self management training for arthritis patients by Kate Lorig modified for the Netherlands by Taal.
In contrast, the patients in the UC group received usual care at the discretion of their attending physician only. Usual care consists of either physical therapy by a local physical therapist or temporary admission to a nursing home, when applicable.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Function ability as measured with the McMaster Toronto Arthritis patient preference questionnaire (MACTAR) and Health Assessment Questionnaire (HAQ).
Secondary outcome measures
1. Quality of life as measured with the RAND-36/Short Form health survey (SF-36) and Arthritis Impact Measurement Scales (AIMS)
2. Mobility as measured with the Escola Paulista de Medicina Range Of Motion (EPM-ROM)
3. Pain, general health as measured with a Visual Analogue Scale
4. Costs
Overall trial start date
01/01/2002
Overall trial end date
05/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged over 18
2. Rheumatoid Arthritis (RA) according to the American College of Rheumatology (ACR) 1987 or polyarticular OsteoArthritis (OA)
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
130
Participant exclusion criteria
1. Presence of serious cardiac disease (New York Heart Association [NYHA] class III and IV)
2. Incapacitating pulmonary disease Global initiative for chronic Obstructive Lung Disease (GOLD) stage IV
3. Serious hypertension (diastolic blood pressure more than 110 mmHg)
4. Pregnancy
5. Insufficient understanding of the Dutch language
6. Functional incapacity (Steinbrocker functional class four)
Recruitment start date
01/01/2002
Recruitment end date
05/01/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
University of Twente
Enschede
7500 AE
Netherlands
Sponsor information
Organisation
University of Twente (The Netherlands)
Sponsor details
Institute for Behavioural Research
Department of Psychology and Communication of Health Risk (PCHR)
P.O. Box 217
Enschede
7500 AE
Netherlands
+31 (0)53 489 2398
m.a.f.j.vandelaar@utwente.nl
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
RVVZ (Reserve Voormalige Vrijwillige Ziekenfondsen) a governmental non profit health organisation (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dutch Arthritis Foundation (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18240191
Publication citations
-
Results
Bulthuis Y, Mohammad S, Braakman-Jansen LM, Drossaers-Bakker KW, van de Laar MA, Cost-effectiveness of intensive exercise therapy directly following hospital discharge in patients with arthritis: results of a randomized controlled clinical trial., Arthritis Rheum., 2008, 59, 2, 247-254, doi: 10.1002/art.23332.