4-STEPS: a physical activity program for unexplained chronic fatigue

Completed

• Conditions: Idiopathic chronic fatigue/chronic fatigue syndrome; Nervous System Diseases; Postviral fatigue syndrome

• Registration Number: ISRCTN70763996
• Lead Sponsor: Foundation for Science and Technology (Fundação para a Ciência e Tecnologia) (Portugal)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue severity (CIS-R) measured at baseline, time 2 (3 months later) and time 3 (12 months later)

Secondary Outcome Measures

Name	Time	Method
1. Self-regulation skills (SRSB questionnaire)<br>2. Autonomous/controlled motivation (TSRQ)<br>3. Self-efficacy (goal efficacy from the SRSB and barriers efficacy from Barriers efficacy scale)<br>4. Behavioral responses to illness (BRIQ)<br>5. Psychological symptoms (depression and anxiety subscales of the BSI)<br>6. Somatic symptoms (PHQ-15)<br>7. Quality of sleep <br>8. Social support <br>9. Physical activity (Yamax SW-200 pedometer and self-report)<br>10. Physical and mental functioning (SF-12 v.2)<br>11. ICF and CFS diagnosis (CDS-CFS symptom inventory)<br>12. Fatigue impact (adapted sub-scale of BPI); need for recovery (NFR scale)<br>13. Use of healthcare resources<br>Measured at baseline, time 2 (3 months later) and time 3 (12 months later)