Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

Fatigue Clinical Trial

Official title:

Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01035203
• Other study ID #: 176-25/kmo
• Status: Recruiting
• Phase: Phase 3
• First received: December 17, 2009
• Last updated: March 29, 2010
• Start date: December 2009
• Est. completion date: September 2010

Study information

• Verified date: March 2010
• Source: Charite University, Berlin, Germany
• Contact: Fernando Dimeo, MD
• Phone: +493084452098
• Email: fernando.dimeo[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Maximal Oxygen Uptake
• Mood

Intervention

Behavioral:
• Exercise
Endurance exercise 3 times weekly for 45 minutes, 4 weeks long
• Cognitive behavioural therapy
Teaching of techniques to reduce fatigue and to improve stamina

Locations

Country	Name	City	State
Germany	Department of Sports Medicine	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue scores on the Brief Fatigue Inventory (BFI)		4 weeks	No
Secondary	Maximal oxygen uptake (VO2max) on a treadmill stress test.		4 weeks	No
Secondary	Scores on the HADS (Hospital Anxiety and Depression Scale)		4 weeks	No