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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00163644
Other study ID # 144/02
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 11, 2005
Last updated January 6, 2016
Start date November 2003

Study information

Verified date January 2016
Source Bayside Health
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 66
Est. completion date
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
aereobic plus resisted exercise

aerobic plus active exercise

Other:
No formal exercise plus phone calls


Locations

Country Name City State
Australia Alfred hospital Physiotherapy dept, Melbourne Victoria

Sponsors (3)

Lead Sponsor Collaborator
Bayside Health The Alfred, The Leukaemia Foundation of Victoria

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical performance. At 6 weeks No
Primary Quality of Life. At 6 weeks No
Primary Anthropometry and Grip strength At 6 weeks No
Secondary Heart Rate. At 6 weeks No
Secondary No adverse events during treatment. At 6 weeks Yes
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