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

Bayside Health

Status: Unknown

Conditions: Hematological Malignancies

Treatments: Procedure: aerobic plus active exercise; Other: No formal exercise plus phone calls; Procedure: aereobic plus resisted exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00163644

144/02

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Aerobic exercise plus resistance

Active Comparator group

Description:

Aerobic exercise plus resistance exercise for 6 weeks

Treatment:

Procedure: aereobic plus resisted exercise

Aerobic exercise

Active Comparator group

Description:

Aerobic exercise for 6 weeks

Treatment:

Procedure: aerobic plus active exercise

Control

Other group

Description:

No formal exercise and weekly phone calls

Treatment:

Other: No formal exercise plus phone calls