RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT
Recruitment status was Recruiting
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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 |
- Physical performance.
- Quality of Life.
- Anthropometry and Grip strength
- Heart Rate.
- No adverse events during treatment.
| Estimated Enrollment: | 66 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | September 2005 |
A three group, single blinded, randomised trial was designed to compare the effects of
- aerobic plus active exercise and
- aerobic plus resistance exercise to
- control group of bone marrow/haemopoietic recipients not recieving exercise.
The hypotheses being tested is that
- Exercise improves the physical performance of transplants recipients.
- Exercise improves the quality of life of these patients;
- resisted exercise added to aerobic exercise increases muscle strength or lean muscle mass and
- 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 |
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| 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 |
| 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 | |
| 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 Hematologic Neoplasms Neoplasms by Site Hematologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013