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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Alfred
The Leukaemia Foundation of Victoria
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163644
First received: September 11, 2005
Last updated: January 6, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Hematological Malignancies
Procedure: aereobic plus resisted exercise
Procedure: aerobic plus active exercise
Other: No formal exercise plus phone calls

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Investigate the Effects of an Exercise Programme on Physical Performance and Quality of Life After a Bone Marrow Transplant

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Physical performance. [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
  • Quality of Life. [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
  • Anthropometry and Grip strength [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart Rate. [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
  • No adverse events during treatment. [ Time Frame: At 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: November 2003
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Control
No formal exercise and weekly phone calls
Other: No formal exercise plus phone calls

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163644

Locations
Australia, Victoria
Alfred hospital Physiotherapy dept,
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
The Alfred
The Leukaemia Foundation of Victoria
Investigators
Principal Investigator: Catherine M Walsh, dip. physio Bayside Health
  More Information

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00163644     History of Changes
Other Study ID Numbers: 144/02 
Study First Received: September 11, 2005
Last Updated: January 6, 2016
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:
Hematological malignancies.
Bone- marrow/ haemopoetic transplant
Exercise

ClinicalTrials.gov processed this record on May 26, 2016