Clinical trial NCT00402753: Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients
Official title: Physical Exercise to Improve Physical Performance and Health Related Quality of Life in Hematopoietic Stem Cell Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Cancer, Exercise, Health Related Quality of Life, PBSCT
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2006-11-22
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Musculoskeletal performance
timeFrame: Baseline -3 months - 6 months
measure: Knee extension strength
timeFrame: Baseline -3 months - 6 months
measure: Grip Strength
timeFrame: Baseline -3 months - 6 months
measure: 6 minute walk test
timeFrame: Baseline -3 months - 6 months
measure: 15-meter walking speed
timeFrame: Baseline -3 months - 6 months
measure: and Health Related Quality of Life: (Physical function subscale of the EORTC-QLQ-C30 questionnaire).
timeFrame: Baseline -3 months - 6 months
Secondary outcomes:
measure: 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.
timeFrame: Baseline -3 months - 6 months
measure: Self-reported fatigue
timeFrame: Baseline -3 months - 6 months
measure: Self-reported and objectively assessed physical activity
timeFrame: Baseline -3 months - 6 months
measure: Whole body composition
timeFrame: Baseline -3 months - 6 months
measure: Haemotological values: e.g Hemoglobin
timeFrame: Baseline -3 months - 6 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Hogeschool Utrecht, University of Professional Education, Faculty of Health Care, Chair of Lifestyle and Health
city: Münsterlingen
country: Switzerland
facility: Cantonal Hospital Münsterlingen
city: St.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
name: Neil K Aaronson, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1200/JCO.2005.02.148.
citation: Schmitz KH, Holtzman J, Courneya KS, Masse 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. doi: 10.1158/1055-9965.EPI-04-0703.
citation: Galvao DA, Newton RU. Review of exercise intervention studies in cancer patients. J Clin Oncol. 2005 Feb 1;23(4):899-909. doi: 10.1200/JCO.2005.06.085.