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Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients

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ClinicalTrials.gov Identifier: NCT00402753
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : January 7, 2010
Information provided by:
University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Behavioral: Ambulatory Physical Exercise Program Early Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Physical Exercise to Improve Physical Performance and Health Related Quality of Life in Hematopoietic Stem Cell Transplantation Recipients
Study Start Date : January 2005
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1
Physical exercise group: Combined supervised physical activity: Endurance and Resistive strength
Behavioral: Ambulatory Physical Exercise Program
supervised exercise, 2 x / week
No Intervention: Group 2
Usual care control group

Primary Outcome Measures :
  1. Musculoskeletal performance [ Time Frame: Baseline -3 months - 6 months ]
  2. Knee extension strength [ Time Frame: Baseline -3 months - 6 months ]
  3. Grip Strength [ Time Frame: Baseline -3 months - 6 months ]
  4. 6 minute walk test [ Time Frame: Baseline -3 months - 6 months ]
  5. 15-meter walking speed [ Time Frame: Baseline -3 months - 6 months ]
  6. and Health Related Quality of Life: (Physical function subscale of the EORTC-QLQ-C30 questionnaire). [ Time Frame: Baseline -3 months - 6 months ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Baseline -3 months - 6 months ]
  2. Self-reported fatigue [ Time Frame: Baseline -3 months - 6 months ]
  3. Self-reported and objectively assessed physical activity [ Time Frame: Baseline -3 months - 6 months ]
  4. Whole body composition [ Time Frame: Baseline -3 months - 6 months ]
  5. Haemotological values: e.g Hemoglobin [ Time Frame: Baseline -3 months - 6 months ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402753

Hogeschool Utrecht, University of Professional Education, Faculty of Health Care, Chair of Lifestyle and Health
Utrecht, Netherlands, 3508 AD
Cantonal Hospital Münsterlingen
Münsterlingen, Switzerland, 8596
Cantonal Hospital St.Gallen
St.Gallen, Switzerland, 9700
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Study Chair: Neil K Aaronson, PhD Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.