Back to resultsRCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT
Primary Purpose
Hematological Malignancies
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
aereobic plus resisted exercise
aerobic plus active exercise
No formal exercise plus phone calls
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancies focused on measuring Hematological malignancies., Bone- marrow/ haemopoetic transplant, Exercise
Eligibility 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
Sites / Locations
- Alfred hospital Physiotherapy dept,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Aerobic exercise plus resistance
Aerobic exercise
Control
Arm Description
Aerobic exercise plus resistance exercise for 6 weeks
Aerobic exercise for 6 weeks
No formal exercise and weekly phone calls
Outcomes
Primary Outcome Measures
Physical performance.
Quality of Life.
Anthropometry and Grip strength
Secondary Outcome Measures
Heart Rate.
No adverse events during treatment.
Full Information
NCT ID
NCT00163644
First Posted
September 11, 2005
Last Updated
January 6, 2016
Sponsor
Bayside Health
Collaborators
The Alfred, The Leukaemia Foundation of Victoria
1. Study Identification
Unique Protocol Identification Number
NCT00163644
Brief Title
RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
Collaborators
The Alfred, The Leukaemia Foundation of Victoria
4. Oversight
5. Study Description
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies
Keywords
Hematological malignancies., Bone- marrow/ haemopoetic transplant, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise plus resistance
Arm Type
Active Comparator
Arm Description
Aerobic exercise plus resistance exercise for 6 weeks
Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Description
Aerobic exercise for 6 weeks
Arm Title
Control
Arm Type
Other
Arm Description
No formal exercise and weekly phone calls
Intervention Type
Procedure
Intervention Name(s)
aereobic plus resisted exercise
Intervention Type
Procedure
Intervention Name(s)
aerobic plus active exercise
Intervention Type
Other
Intervention Name(s)
No formal exercise plus phone calls
Primary Outcome Measure Information:
Title
Physical performance.
Time Frame
At 6 weeks
Title
Quality of Life.
Time Frame
At 6 weeks
Title
Anthropometry and Grip strength
Time Frame
At 6 weeks
Secondary Outcome Measure Information:
Title
Heart Rate.
Time Frame
At 6 weeks
Title
No adverse events during treatment.
Time Frame
At 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine M Walsh, dip. physio
Organizational Affiliation
Bayside Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred hospital Physiotherapy dept,
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT
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