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

Hematological Malignancies Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00163644
• Other study ID #: 144/02
• 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. 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

• Hematological Malignancies

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