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Hematopoietic Stem Cell TransplantationEarly Phase 1NCT00402753

Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients

A Early Phase 1 study testing Ambulatory Physical Exercise Program in people with Hematopoietic Stem Cell Transplantation, run by University of Zurich at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hematopoietic Stem Cell Transplantation
What is being tested?
Ambulatory Physical Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
4 sitesin 2 countries
Study dates
Jan 2005to Dec 2009
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Switzerland3 sites

  • Cantonal Hospital Münsterlingen

    Münsterlingen, 8596

  • Cantonal Hospital St.Gallen

    Sankt Gallen, 9700

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

Netherlands1 site

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

    Utrecht, 3508 AD

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Ambulatory Physical Exercise Program
Keywords
Cancer, Exercise, Health Related Quality of Life, PBSCT
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ambulatory Physical Exercise ProgramBehavioural

    supervised exercise, 2 x / week

Study groups in NCT00402753
Study groupRoleWhat they receive
Group 1ExperimentalPhysical exercise group: Combined supervised physical activity: Endurance and Resistive strength
Receives: Behavioral: Ambulatory Physical Exercise Program
Group 2No interventionUsual care control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Musculoskeletal performance

    Measured: Baseline -3 months - 6 months

  2. Knee extension strength

    Measured: Baseline -3 months - 6 months

  3. Grip Strength

    Measured: Baseline -3 months - 6 months

  4. 6 minute walk test

    Measured: Baseline -3 months - 6 months

  5. 15-meter walking speed

    Measured: Baseline -3 months - 6 months

  6. and Health Related Quality of Life: (Physical function subscale of the EORTC-QLQ-C30 questionnaire).

    Measured: Baseline -3 months - 6 months

Secondary outcomes (5)

  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.

    Measured: Baseline -3 months - 6 months

  2. Self-reported fatigue

    Measured: Baseline -3 months - 6 months

  3. Self-reported and objectively assessed physical activity

    Measured: Baseline -3 months - 6 months

  4. Whole body composition

    Measured: Baseline -3 months - 6 months

  5. Haemotological values: e.g Hemoglobin

    Measured: Baseline -3 months - 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402753
Sponsor's protocol ID
EK-519
Status last verified
Jan 2010
First submitted
20 Nov 2006
Last updated
7 Jan 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15923576

  • 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.

    PubMed 16030088

  • 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.

    PubMed 15681536

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ambulatory Physical Exercise Program in people with Hematopoietic Stem Cell Transplantation, run by University of Zurich at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Musculoskeletal performance (time frame: Baseline -3 months - 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402753, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2010.

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