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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00163644




Registration number
NCT00163644
Ethics application status
Date submitted
11/09/2005
Date registered
14/09/2005
Date last updated
8/01/2016

Titles & IDs
Public title
RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT
Scientific title
Randomised Controlled Trial to Investigate the Effects of an Exercise Programme on Physical Performance and Quality of Life After a Bone Marrow Transplant
Secondary ID [1] 0 0
144/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematological Malignancies 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - aereobic plus resisted exercise
Treatment: Surgery - aerobic plus active exercise
Other interventions - No formal exercise plus phone calls

Active Comparator: Aerobic exercise plus resistance - Aerobic exercise plus resistance exercise for 6 weeks

Active Comparator: Aerobic exercise - Aerobic exercise for 6 weeks

Other: Control - No formal exercise and weekly phone calls


Treatment: Surgery: aereobic plus resisted exercise


Treatment: Surgery: aerobic plus active exercise


Other interventions: No formal exercise plus phone calls
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Physical performance.
Timepoint [1] 0 0
At 6 weeks
Primary outcome [2] 0 0
Quality of Life.
Timepoint [2] 0 0
At 6 weeks
Primary outcome [3] 0 0
Anthropometry and Grip strength
Timepoint [3] 0 0
At 6 weeks
Secondary outcome [1] 0 0
Heart Rate.
Timepoint [1] 0 0
At 6 weeks
Secondary outcome [2] 0 0
No adverse events during treatment.
Timepoint [2] 0 0
At 6 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
febrile neutropenia Have active graft versus host disease Have cardiomyopathy (ejection
fraction < 20%) require > 28% oxygen

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred hospital Physiotherapy dept, - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Leukaemia Foundation of Victoria
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00163644
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Catherine M Walsh, dip. physio
Address 0 0
Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163644