Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients

Early Phase 1

Completed

• Conditions: Hematopoietic Stem Cell Transplantation
• Interventions: Behavioral: Ambulatory Physical Exercise Program

• Registration Number: NCT00402753
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-22
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-06
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 1	Ambulatory Physical Exercise Program	Physical exercise group: Combined supervised physical activity: Endurance and Resistive strength

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland

Cantonal Hospital Münsterlingen; 🇨🇭 Münsterlingen, Switzerland

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

Cantonal Hospital St.Gallen; 🇨🇭 St.Gallen, Switzerland