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

Study Overview
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Brief Summary
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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
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A three group, single blinded, randomised trial was designed to compare the effects of aerobic plus active exercise and aerobic plus resistance exercise to control group of bone marrow/haemopoietic recipients not recieving exercise. The hypotheses being tested is that Exercise improves the physical performance of transplants recipients. Exercise improves the quality of life of these patients; resisted exercise added to aerobic exercise increases muscle strength or lean muscle mass and There are no adverse events during either form of exercise

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

Conditions
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Hematological Malignancies

Intervention / Treatment
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* Procedure: aereobic plus resisted exercise
* Procedure: aerobic plus active exercise
* Other: No formal exercise plus phone calls


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobic exercise plus resistance<br>Aerobic exercise plus resistance exercise for 6 weeks | Procedure: aereobic plus resisted exercise<br> <br> |
| Active Comparator: Aerobic exercise<br>Aerobic exercise for 6 weeks | Procedure: aerobic plus active exercise<br> <br> |
| Other: Control<br>No formal exercise and weekly phone calls | Other: No formal exercise plus phone calls<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance. |  | At 6 weeks | 
| Quality of Life. |  | At 6 weeks | 
| Anthropometry and Grip strength |  | At 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate. |  | At 6 weeks | 
| No adverse events during treatment. |  | At 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematological malignancies., Bone- marrow/ haemopoetic transplant, Exercise