Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00402753
First received: November 20, 2006
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Hematopoietic Stem Cell Transplantation
Behavioral: Ambulatory Physical Exercise Program
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Musculoskeletal performance [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]
  • Knee extension strength [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]
  • Grip Strength [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]
  • 6 minute walk test [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]
  • 15-meter walking speed [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]
  • and Health Related Quality of Life: (Physical function subscale of the EORTC-QLQ-C30 questionnaire). [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Self-reported fatigue [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]
  • Self-reported and objectively assessed physical activity [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]
  • Whole body composition [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]
  • Haemotological values: e.g Hemoglobin [ Time Frame: Baseline -3 months - 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: January 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402753

Locations
Netherlands
Hogeschool Utrecht, University of Professional Education, Faculty of Health Care, Chair of Lifestyle and Health
Utrecht, Netherlands, 3508 AD
Switzerland
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
Investigators
Study Chair: Neil K Aaronson, PhD Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
  More Information

Publications:
Responsible Party: Daniel Uebelhart MD, University Hospital Zurich
ClinicalTrials.gov Identifier: NCT00402753     History of Changes
Other Study ID Numbers: EK-519
Study First Received: November 20, 2006
Last Updated: January 6, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Cancer, Exercise, Health Related Quality of Life, PBSCT

ClinicalTrials.gov processed this record on September 16, 2014