Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Physical Exercise to Improve Physical Performance and Health Related Quality of Life in Hematopoietic Stem Cell Transplantation Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402753
• Other study ID #: EK-519
• Status: Completed
• Phase: Phase 0
• First received: November 20, 2006
• Last updated: January 6, 2010
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The proposed study in an inception cohort of patients with hematological malignancies treated with PBSCT is designed to evaluate the effects of a physical exercise intervention on muscular-skeletal, physical activity and quality of life outcomes.

Description:

Peripheral Stem Cell Transplantation is a frequently used therapy option to increase survival in hematological and lymphatic malignancies. These malignancies and their treatment are associated with numerous physical and psychological symptoms and severe side effects. Physical exercise has been proposed as a promising strategy for the treatment of some of these physical and psychological complaints, and various exercise interventions are currently available after cancer treatment. To date, promising preliminary results concerning exercise programs in PBSCT recipients were published with limited sample size populations. Results of musculoskeletal outcomes in PBSCT recipients after cancer treatment are lacking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Status after high-dose chemotherapy following Hematopoietic Stem Cell Transplantation

• Willing to enter a physical exercise program

• Good understanding of the German language

• Written informed consent

Exclusion Criteria:

• Uncontrolled cardiovascular disease and myocardial infarction in the previous six months

• Uncontrolled hypertension

• Uncontrolled thyroid disease

• Uncontrolled diabetes

• Diagnosis of depression before entering the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation

Intervention

Behavioral:
• Ambulatory Physical Exercise Program
supervised exercise, 2 x / week

Locations

Country	Name	City	State
Netherlands	Hogeschool Utrecht, University of Professional Education, Faculty of Health Care, Chair of Lifestyle and Health	Utrecht
Switzerland	Cantonal Hospital Münsterlingen	Münsterlingen
Switzerland	Cantonal Hospital St.Gallen	St.Gallen
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Countries where clinical trial is conducted

Netherlands,  Switzerland, 

References & Publications (3)

Galvão DA, Newton RU. Review of exercise intervention studies in cancer patients. J Clin Oncol. 2005 Feb 1;23(4):899-909. Review. — View Citation

Knols R, Aaronson NK, Uebelhart D, Fransen J, Aufdemkampe G. Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials. J Clin Oncol. 2005 Jun 1;23(16):3830-42. Review. — View Citation

Schmitz KH, Holtzman J, Courneya KS, Mâsse LC, Duval S, Kane R. Controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2005 Jul;14(7):1588-95. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Musculoskeletal performance		Baseline -3 months - 6 months	No
Primary	Knee extension strength		Baseline -3 months - 6 months	No
Primary	Grip Strength		Baseline -3 months - 6 months	No
Primary	6 minute walk test		Baseline -3 months - 6 months	No
Primary	15-meter walking speed		Baseline -3 months - 6 months	No
Primary	and Health Related Quality of Life: (Physical function subscale of the EORTC-QLQ-C30 questionnaire).		Baseline -3 months - 6 months	No
Secondary	Role-,cognitive-,emotional-,social-,symptom scales and the global health and quality of life scale of the EORTC-QLQ-C30 Health Related Quality of Life questionnaire.		Baseline -3 months - 6 months	No
Secondary	Self-reported fatigue		Baseline -3 months - 6 months	No
Secondary	Self-reported and objectively assessed physical activity		Baseline -3 months - 6 months	No
Secondary	Whole body composition		Baseline -3 months - 6 months	No
Secondary	Haemotological values: e.g Hemoglobin		Baseline -3 months - 6 months	No