NCT00402753

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for early_phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 7, 2010

Status Verified

January 1, 2010

Enrollment Period

4.9 years

First QC Date

November 20, 2006

Last Update Submit

January 6, 2010

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Cancer, Exercise, Health Related Quality of Life, PBSCT

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Group 1

EXPERIMENTAL

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

Behavioral: Ambulatory Physical Exercise Program

Group 2

NO INTERVENTION

Usual care control group

Interventions

Ambulatory Physical Exercise ProgramBEHAVIORAL

supervised exercise, 2 x / week

Group 1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Utrecht, 3508 AD, Netherlands

Location

Cantonal Hospital Münsterlingen

Münsterlingen, 8596, Switzerland

Location

Cantonal Hospital St.Gallen

Sankt Gallen, 9700, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 15923576BACKGROUND

  • 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.

    PMID: 16030088BACKGROUND

  • 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.

    PMID: 15681536BACKGROUND

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Neil K Aaronson, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

January 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 7, 2010

Record last verified: 2010-01

Locations

NL(1)CH(3)