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

January 6, 2016 updated by: Bayside Health

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred hospital Physiotherapy dept,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart Rate.
Time Frame: At 6 weeks
At 6 weeks
No adverse events during treatment.
Time Frame: At 6 weeks
At 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Collaborators

The Alfred
The Leukaemia Foundation of Victoria

Investigators

  • Principal Investigator: Catherine M Walsh, dip. physio, Bayside Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 144/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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