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

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ClinicalTrials.gov Identifier: NCT00163644
Recruitment Status : Unknown
Verified January 2016 by Bayside Health.
Recruitment status was:  Active, not recruiting
First Posted : September 14, 2005
Last Update Posted : January 8, 2016
Sponsor:
Collaborators:
The Alfred
The Leukaemia Foundation of Victoria
Information provided by (Responsible Party):
Bayside Health

Brief Summary:
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 or disease Intervention/treatment Phase
Hematological Malignancies Procedure: aereobic plus resisted exercise Procedure: aerobic plus active exercise Other: No formal exercise plus phone calls Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : November 2003
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Aerobic exercise plus resistance
Aerobic exercise plus resistance exercise for 6 weeks
Procedure: aereobic plus resisted exercise
Active Comparator: Aerobic exercise
Aerobic exercise for 6 weeks
Procedure: aerobic plus active exercise
Control
No formal exercise and weekly phone calls
Other: No formal exercise plus phone calls



Primary Outcome Measures :
  1. Physical performance. [ Time Frame: At 6 weeks ]
  2. Quality of Life. [ Time Frame: At 6 weeks ]
  3. Anthropometry and Grip strength [ Time Frame: At 6 weeks ]

Secondary Outcome Measures :
  1. Heart Rate. [ Time Frame: At 6 weeks ]
  2. No adverse events during treatment. [ Time Frame: At 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163644


Locations
Australia, Victoria
Alfred hospital Physiotherapy dept,
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
The Alfred
The Leukaemia Foundation of Victoria
Investigators
Principal Investigator: Catherine M Walsh, dip. physio Bayside Health

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00163644     History of Changes
Other Study ID Numbers: 144/02
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016

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

Additional relevant MeSH terms:
Neoplasms