RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Alfred
The Leukaemia Foundation of Victoria
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163644
First received: September 11, 2005
Last updated: December 7, 2005
Last verified: September 2005
  Purpose

The hypothesis is that exercise will improve the physical performance and quality of life of bone marrow/ haemopoietic stem cell transplants.The aim of the trial is to provide definite clinical evidence as to which( if any) type of exercise is most beneficial for this patient population. It is also aimed at improving the provision of physiotherapy services to this group of patients.


Condition Intervention
Hematological Malignancies
Procedure: aereobic plus resisted exercise
Procedure: aerobic plus active exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Investigate the Effects of an Exercise Programme on Physical Performance and Quality of Life After a Bone Marrow Transplant

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Physical performance.
  • Quality of Life.
  • Anthropometry and Grip strength

Secondary Outcome Measures:
  • Heart Rate.
  • No adverse events during treatment.

Estimated Enrollment: 66
Study Start Date: November 2003
Estimated Study Completion Date: September 2005
Detailed Description:

A three group, single blinded, randomised trial was designed to compare the effects of

  1. aerobic plus active exercise and
  2. aerobic plus resistance exercise to
  3. control group of bone marrow/haemopoietic recipients not recieving exercise.

The hypotheses being tested is that

  1. Exercise improves the physical performance of transplants recipients.
  2. Exercise improves the quality of life of these patients;
  3. resisted exercise added to aerobic exercise increases muscle strength or lean muscle mass and
  4. There are no adverse events during either form of exercise
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Recipient bone marrow transplant Alfred Hospital, Platelets >= 20 x 10E9 / l Provide written consent, 30 days after a bone marrow transplant have an absolute neutrophil count of 1x10E9/l be in a stable medical condition

Exclusion Criteria:

febrile neutropenia Have active graft versus host disease Have cardiomyopathy (ejection fraction < 20%) require > 28% oxygen

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163644

Contacts
Contact: Catherine M Walsh, dip. physio 92762000 ext 3450 c.walsh@alfred.org.au
Contact: Anne Holland, Doctorate 92762000 ext 3450 a.holland@alfred.org.au

Locations
Australia, Victoria
Alfred hospital Physiotherapy dept, Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Catherine M Walsh, dip. physio    03 92762000 ext 3450    c.walsh@alfred.org.au   
Contact: Anne Holland, Doctorate    92762000 ext 3450    a.holland@alfred.org.au   
Principal Investigator: Catherine M Walsh, dip. physio         
Sponsors and Collaborators
Bayside Health
The Alfred
The Leukaemia Foundation of Victoria
Investigators
Principal Investigator: Catherine M Walsh, dip. physio Bayside Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163644     History of Changes
Other Study ID Numbers: 144/02
Study First Received: September 11, 2005
Last Updated: December 7, 2005
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:
Hematological malignancies.
Bone- marrow/ haemopoetic transplant
Exercise

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014