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

Four steps (4-STEPS): a self-regulation based intervention for physical activity adherence in chronic fatigue patients - a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70763996

Enrollment

100

Registered

2012-01-25

Start date

2011-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic chronic fatigue/chronic fatigue syndrome Nervous System Diseases Postviral fatigue syndrome

Interventions

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 m

Eligibility

Sex/Gender

All

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
Fatigue severity (CIS-R) measured at baseline, time 2 (3 months later) and time 3 (12 months later)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026