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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN70763996 |
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Date of registration:
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25/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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4-STEPS: a physical activity program for unexplained chronic fatigue
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Scientific title:
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Four steps (4-STEPS): a self-regulation based intervention for physical activity adherence in chronic fatigue patients - a randomized controlled trial |
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Date of first enrolment:
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01/01/2011 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN70763996 |
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Study type:
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Interventional |
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Study design:
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Multi-centre randomized controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Stan
Maes |
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Address:
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PO Box 9555
2300 RB
Leiden
Netherlands |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic chronic fatigue/chronic fatigue syndrome
Nervous System Diseases
Postviral fatigue syndrome
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Intervention(s)
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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 prevention.
4. A pedometer to register physical activity (steps taken) on a daily basis.
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Primary Outcome(s)
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Fatigue severity (CIS-R) measured at baseline, time 2 (3 months later) and time 3 (12 months later)
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Secondary Outcome(s)
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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 healthcare resources
Measured at baseline, time 2 (3 months later) and time 3 (12 months later)
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Source(s) of Monetary Support
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Foundation for Science and Technology (Fundação para a Ciência e Tecnologia) (Portugal) (SFRH/BD/47579/2008)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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