The intervention consists of:
[..]
4. A pedometer to register physical activity (steps taken) on a daily basis=
.
It is also being used as a (secondary) outcome measure
------------------------------
http://apps.who.int/trialsearch/trial.aspx?TrialID=3DISRCTN70763996
Register: ISRCTN
Last refreshed on: 21 February 2012
Main ID: ISRCTN70763996
Date of registration: 25/01/2012
Primary sponsor: Foundation for Science and Technology (Funda=E7=E3o para
a Ci=EAncia e Tecnologia) (Portugal)
Public title: 4-STEPS: a physical activity program for unexplained
chronic fatigue4-STEPS
Scientific title: Four steps (4-STEPS): A self-regulation based
intervention for physical activity adherence in chronic fatigue
patients - A Randomized controlled trial
Date of first enrolment: Jan 1 2011
Target sample size: 100
Recruitment status: Ongoing/Recruiting
URL: http://isrctn.org/ISRCTN70763996
Study type: Interventional
Study design: Multi-centre randomized controlled trial
Countries of recruitment Portugal
Contacts
Name: Stan Maes
Address: PO Box 95552300 RBLeidenNetherlands
Telephone:
Email:
Affiliation:
Key inclusion & exclusion criteria
Inclusion criteria:
1. Meeting the operationalised criteria for [idiopathic chronic
fatigue/ chronic fatigue syndrome (ICF/CFS) (CDC criteria)]
2. Aged between 18 and 65
3. Fluent in spoken Portuguese
Exclusion criteria:
1. Presence of concurrent somatic condition which in the judgment of
the physician could explain the fatigue symptoms
2. Presence of severe psychiatric disorder (e.g. psychotic illness)
Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Idiopathic Chronic Fatigue / Chronic Fatigue Syndrome
Intervention(s)
The control condition receives usual care.
The experimental condition receives the self-regulation based physical
activity intervention.
The intervention consists of:
1. Two face-to-face individual motivational interviews, aimed at
exploring important health and life goals, increase participants
motivation and confidence to be physically active and set a specific
physical activity goal. These sessions have a 2 weeks interval and the
duration of the sessions is approximately 1 hour.
2. A self-regulation booklet to help patients pursue their physical
activity goal. The booklet contains information and activities related
to the main self-regulation skills, such as goal efficacy, goal
planning, goal setting, self-monitoring, emotional control, cope with
problems and relapse prevention.
3. Two monthly brief telephone counseling sessions aimed at relapse prevent=
ion.
4. A pedometer to register physical activity (steps taken) on a daily basis=
.
Primary Outcome(s) Fatigue severity (CIS-R) measured at baseline, time
2 (3 months later) and time 3 (12 months later)
Secondary Outcome(s)
1. Self-regulation skills (SRSB questionnaire)
2. Autonomous/controlled motivation (TSRQ)
3. Self-efficacy (goal-efficacy from the SRSB and barriers efficacy
from Barriers efficacy scale)
4. Behavioral responses to illness (BRIQ)
5. Psychological symptoms (Depression and anxiety subscales of the BSI)
6. Somatic symptoms (PHQ-15)
7. Quality of sleep
8. Social support
9. Physical activity (Yamax SW-200 pedometer and self-report)
10. Physical and mental functioning (SF-12 v.2)
11. ICF and CFS diagnosis (CDS-CFS symptom inventory)
12. Fatigue impact (adapted sub-scale of BPI);need for recovery (NFR scale)
13. Use of health care resources
Meausred at baseline, Time 2 (3 months later) and Time 3 (12 months later):
Secondary ID(s) N/A
Source(s) of Monetary Support Foundation for Science and Technology
(Funda=E7=E3o para a Ci=EAncia e Tecnologia) (Portugal) (SFRH/BD/47579/2008=
)
Secondary Sponsor(s) N/A
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World Health Organization be liable for any damages arising from the
use of the information linked to in this section. None of the
information obtained through use of the search portal should in any
way be used in clinical care without consulting a physician or
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record.
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