Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients

NCT ID: NCT00402753

Last Updated: 2010-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1

Physical exercise group: Combined supervised physical activity: Endurance and Resistive strength

Group Type EXPERIMENTAL

Ambulatory Physical Exercise Program

Intervention Type BEHAVIORAL

supervised exercise, 2 x / week

Group 2

Usual care control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ambulatory Physical Exercise Program

supervised exercise, 2 x / week

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Zurich

Principal Investigators

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Neil K Aaronson, PhD

Role: STUDY_CHAIR

Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.

Locations

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Hogeschool Utrecht, University of Professional Education, Faculty of Health Care, Chair of Lifestyle and Health

Utrecht, , Netherlands

Site Status

Cantonal Hospital Münsterlingen

Münsterlingen, , Switzerland

Site Status

Cantonal Hospital St.Gallen

Sankt Gallen, , Switzerland

Site Status

University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Netherlands Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 15923576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16030088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15681536 (View on PubMed)

Other Identifiers

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EK-519

Identifier Type: -

Identifier Source: org_study_id

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