Exercise Following Autologous Peripheral Blood Stem Cell Transplantation

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00883961
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The study evaluates the effects of a supervised exercise program on the physical performance, the mood and the complications of therapy in patients undergoing a high-dose chemotherapy followed by an autologous peripheral blood stem cell transplantation.

Condition or Disease	Intervention/Treatment	Phase
Hematological Disease	Other: Supervised exercise	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Study Start Date: Dec 1, 2009
• Anticipated Primary Completion Date: Apr 1, 2011
• Anticipated Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supervised exercise	Other: Supervised exercise; The patients will carry out a daily endurance exercise program consisting of walking on a treadmill for 30 minutes at an intensity of about 80% of the maximum heart rate under supervision from study personnel.
No Intervention: Control group The patients will not carry out a structured exercise program.

Outcome Measures

Primary Outcome Measures

1. VO2max [At recruitment and after 3 weeks]

Secondary Outcome Measures

1. Mood [At recruitment and after 3 weeks]

2. Duration of aplasia [3 weeks]

3. Complications during hospitalization [3 weeks]

4. Need for transfusion of platelets and red blood cells [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18-70

• Hematological disease

• Treatment with high-dose chemotherapy followed by autologous stem cell transplantation

• Understanding of written German

Exclusion Criteria:

• Cardiorespiratory, metabolical, osteoarticular or immunological diseases which can be aggravated by exercise

• Pathological stress-ECG at admission

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30	Berlin		Germany	12200

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

• Principal Investigator: Fernando Dimeo, MD, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00883961
• Other Study ID Numbers: EA4/029/09
• First Posted: Apr 20, 2009
• Last Update Posted: Dec 23, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: High-dose chemotherapy; Hematological neoplasties; Fatigue; Cancer; Exercise; Sport; Hematologic neoplastic disorders
• Additional relevant MeSH terms: Hematologic Diseases

Study Results

No Results Posted as of Dec 23, 2009