The objective of the study is to evaluate a fall prevention program for persons with RA. The primary parameter is to reduce fall incidence in the participants of the fall prevention program.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prospective fall incidence: registered for a year by means of monthly fall
registration cards.
Secondary outcome
- Physical activity: (LAPAQ, pedometer for 1 week)
- Walking skills: obstacle avoidance and recording walking pattern in the
laboratory.
- Balance: functional reach and steptest
- Pain: VAS scores on pain in rest and during walking
- Fear of falling and balance confidence: VAS, ABC, SAFFE-NL
- Physical functioning: HAQ
- Quality of life: AIMS2-SF
Background summary
Falls in general, and falls in persons with Rheumatoid Arthritis (RA) in
particular, are an underestimated problem. Retrospective studies show that one
out of three persons with RA experience a fall at least once a year. In the
healthy elderly population the fall incidence rate is approximately 0.45
falls/person year. Our previous work shows that prospectively measured fall
incidence rate in RA is 0.82 falls/person years, well higher than in healthy
elderly. However, patients with RA can not participate in existing programs
targeting fall prevention in the health elderly. Therefore, there is a need to
develop and evaluate a fall prevention program for persons with RA. Several
fall prevention programs have been developed to prevent falls. The Sint
Maartenskliniek, developed the "Nijmegen Falls Prevention Program" (NFPP),
which was effective in reducing the fall incidents with 46% in healthy elderly.
This fall prevention program is already adjusted for persons with osteoporosis.
Since persons with RA have a high fall incidence rate and a higher risk for
injuries it is important to adjust the program for this target group and
evaluate its effectiveness. Developing such an intervention will help RA
patients to prevent falls and, in case a fall still might occur, prevent
injuries.
Study objective
The objective of the study is to evaluate a fall prevention program for persons
with RA. The primary parameter is to reduce fall incidence in the participants
of the fall prevention program.
Study design
Randomized single-blind controlled trial (n=100)
Intervention
Fall prevention program: 11 meetings, twice a week. The content of the program
is based on the original "NFPP" and the fall prevention program for persons
with osteoporosis.
Study burden and risks
Participants have 3 measurements at the Sint Maartenskliniek for approximately
1.5 hours. Furhtermore, they get questionnaires to fill in at home, which will
take about 0.5 hour. The intervention will be 11 meetings of approximately 2
hours each.
Both the measurements as the fall prevention program do not form a high risk
for the participants. These all have been done before in healthy persons as
well as in other patient categories, without any adverse effects.
The most important supposed benefit is a reduction in the number of falls in
the participants. Hereby decreasing the number of injuries and fear of falling.
This will result in a better quality of life and lower medical costs.
Hengstdal 3
6522 JV Nijmegen
Nederland
Hengstdal 3
6522 JV Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
- RA according to the ACR criteria
- history of falls in the prior year
- able to walk 10 minutes without the necessary use of an assistive device
- stable disease activity (based on DAS28 score)
Exclusion criteria
- RA of recent onset (<1 year)
- severe neurological disorder
- medical contra-indication for exercise
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 |
|---|---|
| CCMO | NL24842.091.08 |