Condition category
Musculoskeletal Diseases
Date applied
29/12/2006
Date assigned
16/01/2007
Last edited
22/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.utwente.nl/en/

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

  1. 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.

Additional files

Editorial Notes