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

NCT ID: NCT00163644

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

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

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

Conditions

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Hematological Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aerobic exercise plus resistance

Aerobic exercise plus resistance exercise for 6 weeks

Group Type ACTIVE_COMPARATOR

aereobic plus resisted exercise

Intervention Type PROCEDURE

Aerobic exercise

Aerobic exercise for 6 weeks

Group Type ACTIVE_COMPARATOR

aerobic plus active exercise

Intervention Type PROCEDURE

Control

No formal exercise and weekly phone calls

Group Type OTHER

No formal exercise plus phone calls

Intervention Type OTHER

Interventions

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aereobic plus resisted exercise

Intervention Type PROCEDURE

aerobic plus active exercise

Intervention Type PROCEDURE

No formal exercise plus phone calls

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Alfred

OTHER

Sponsor Role collaborator

The Leukaemia Foundation of Victoria

UNKNOWN

Sponsor Role collaborator

Bayside Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine M Walsh, dip. physio

Role: PRINCIPAL_INVESTIGATOR

Bayside Health

Locations

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Alfred hospital Physiotherapy dept,

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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144/02

Identifier Type: -

Identifier Source: org_study_id

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