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Clinical Trials/NCT00163644
NCT00163644
Unknown
N/A

Randomised Controlled Trial to Investigate the Effects of an Exercise Programme on Physical Performance and Quality of Life After a Bone Marrow Transplant

Bayside Health1 site in 1 country66 target enrollmentNovember 2003

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hematological Malignancies
Sponsor
Bayside Health
Enrollment
66
Locations
1
Primary Endpoint
Physical performance.
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 2003
End Date
December 2009
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Bayside Health
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Physical performance.

Time Frame: At 6 weeks

Quality of Life.

Time Frame: At 6 weeks

Anthropometry and Grip strength

Time Frame: At 6 weeks

Secondary Outcomes

  • Heart Rate.(At 6 weeks)
  • No adverse events during treatment.(At 6 weeks)

Study Sites (1)

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