The primary goal is to explore if CFS patients will act on feedback by changing their physical activity pattern. Furthermore, differences in acting on feedback will be investigated between feedback based on 'temporal comparison' versus…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronische vermoeidheidssyndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the physical activity level measured with an
accelerometer.
Firstly, it will be investigated if the average physical activity pattern
through the day during the distribution of feedback will come closer to the
stipulated norm. Secondly, it will be investigated if the distribution of
feedback tips will lead to a changed physical activity level directly after the
distributed feedback tip.
Secondary outcome
Secondary parameters are:
- On the PDA the physical activity level will be scored subjectively on a
visual analog scale from 0 till 10, and the questions about the experience and
expectation with the feedback tips will be answered with 'yes' or 'no'.
- The behavioral intention/motivation to follow the given feedback in order to
get more balance in the physical activity pattern and determinants which are of
influence on the behavioral intention/motivation will be evaluated by means of
self drafted questionnaire with items scored on a 7 point scale.
- The physical activity level will be measured subjectively by means of the
Baecke questionnaire
- The users satisfaction and usability will be measured with an existing
questionnaire containing 9 items scored on a 5 point scale
- The extent of fatigue will be measured with the CIS20 questionnaire
- Demographical data will be obtained towards age, gender, work status, length
of complaints, diagnose of CFS and level of education.
Background summary
The chronic fatigue syndrome (CFS) is characterized by persistent or relapsing
fatigue lasting for at least 6 months and other additional symptoms. CFS
patients do often have a disturbed balance in their pattern of physical
activities. To combat a disturbed balance, a feedback system has been developed
which provides feedback on physical activities (ABF) carried out in the home
situation of the CFS patient. The expectation is that use of the ABF system in
combination with cognitive behavioral therapy will have additional therapeutic
effect as measured in terms of fatigue and physical functioning. In the
distribution of ambulatory feedback on physical activities, little research has
been done in the most optimal form of feedback distribution. An important
starting point is the way the feedback will be based on. This research will
study if feedback based on a comparison with oneself in time (temporal
comparison) will be act on more than feedback based on a comparison with a
social norm group (social comparison).
Study objective
The primary goal is to explore if CFS patients will act on feedback by changing
their physical activity pattern. Furthermore, differences in acting on feedback
will be investigated between feedback based on 'temporal comparison' versus
'social comparison'.
Secondary will be investigated:
- Experiences and expectations about the feedback tips
- Evaluation of the feedback system by means of users satisfaction and
usability.
- Changes in intention/motivation to achieve a balanced physical activity level
by the distribution of ABF.
- Changes in awareness of the own physical activity level through the
distribution of ABF
Study design
The study design is a randomized prognostic cohort. One group will receive
feedback based on a comparison of their own actual physical activity level with
a healthy norm (social comparison), and the other group will receive feedback
based on a comparison of their own actual physical activity level with a norm
based on their own baseline measurement (temporal comparison).
Intervention
The intervention will consist of the distribution of ambulatory feedback on the
physical activity level by using of a microcomputer of pocket size (PDA) and an
accelerometer. The intervention on the physical activity level shall be given
during a 2 week period in the home situation.
Study burden and risks
The burden for CFS patients consists of the examination of questionnaires, a
baseline measurement during a one week period and feedback on physical
activities during a 2 week period. Participation in this study could be
experienced as aggravating and therefore influence the CFS complaints
negatively.
Roessinghsbleekweg 33b
7522AH Enschede
NL
Roessinghsbleekweg 33b
7522AH Enschede
NL
Listed location countries
Age
Inclusion criteria
Persistent or relapsing unexplained chronic fatigue lasting 6 or more consecutive months (Fukuda et al, 1994);Age between 18-65 years
Exclusion criteria
In treatment with (pre)clinical hospitalisation for complaints of chronic fatigue during participation in the trial;Wheelchair bounded patients;Pathological disorder diagnosed by general practitioner or medical specialist, which could explain the complaints of chronic fatigue;Insufficient control of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL29029.044.09 |
| OMON | NL-OMON26523 |