Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

Phase 3

• Conditions: Fatigue; Mood; Maximal Oxygen Uptake
• Interventions: Behavioral: Cognitive behavioural therapy; Behavioral: Exercise

• Registration Number: NCT01035203
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-29
• Last Update Posted: 2010-03-30
• Primary Completion: 2010-07
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18-70
• Histologically confirmed neoplastic disease
• Treatment (chemotherapy or radiation) completed.
• No treatment in the previous 4 weeks
• Ability to understand written German

Exclusion Criteria

• Health conditions which can be aggravated by exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioural therapy	Cognitive behavioural therapy	-
Exercise	Exercise	Endurance training (walking on a treadmill) 3 x weekly for 4 weeks

Primary Outcome Measures

Name	Time	Method
Fatigue scores on the Brief Fatigue Inventory (BFI)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Maximal oxygen uptake (VO2max) on a treadmill stress test.	4 weeks
Scores on the HADS (Hospital Anxiety and Depression Scale)	4 weeks

Trial Locations

Locations (1)

Department of Sports Medicine; 🇩🇪 Berlin, Germany