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

Not Applicable

• Conditions: Hematological Malignancies
• Interventions: Procedure: aereobic plus resisted exercise; Other: No formal exercise plus phone calls; Procedure: aerobic plus active exercise

• Registration Number: NCT00163644
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-14
• Primary Completion: 2009-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aerobic exercise plus resistance	aereobic plus resisted exercise	Aerobic exercise plus resistance exercise for 6 weeks
Control	No formal exercise plus phone calls	No formal exercise and weekly phone calls
Aerobic exercise	aerobic plus active exercise	Aerobic exercise for 6 weeks

Primary Outcome Measures

Name	Time	Method
Physical performance.	At 6 weeks
Quality of Life.	At 6 weeks
Anthropometry and Grip strength	At 6 weeks

Secondary Outcome Measures

Name	Time	Method
Heart Rate.	At 6 weeks
No adverse events during treatment.	At 6 weeks

Trial Locations

Locations (1)

Alfred hospital Physiotherapy dept,; 🇦🇺 Melbourne, Victoria, Australia