Skip to main content
OpenTrials
Completed

NCT Number: NCT00402753

Ambulatory Physical Exercise Program 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematopoietic Stem Cell Transplantation Behavior Motor Activity Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ambulatory Physical Exercise Program

Behavioral

supervised exercise, 2 x / week

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 22, 2006
Registry last updated
Jan 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.