Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients

January 6, 2010 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

128

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 AD
        • Hogeschool Utrecht, University of Professional Education, Faculty of Health Care, Chair of Lifestyle and Health
  • Switzerland
      • Münsterlingen, Switzerland, 8596
        • Cantonal Hospital Münsterlingen
      • St.Gallen, Switzerland, 9700
        • Cantonal Hospital St.Gallen
      • Zurich, Switzerland, 8091
        • University Hospital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline -3 months - 6 months
Self-reported fatigue
Time Frame: Baseline -3 months - 6 months
Baseline -3 months - 6 months
Self-reported and objectively assessed physical activity
Time Frame: Baseline -3 months - 6 months
Baseline -3 months - 6 months
Whole body composition
Time Frame: Baseline -3 months - 6 months
Baseline -3 months - 6 months
Haemotological values: e.g Hemoglobin
Time Frame: Baseline -3 months - 6 months
Baseline -3 months - 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Study Chair: Neil K Aaronson, PhD, Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

January 7, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EK-519

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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