NCT00163644

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

6.1 years

First QC Date

September 11, 2005

Last Update Submit

January 6, 2016

Conditions

Hematological Malignancies

Keywords

Hematological malignancies.Bone- marrow/ haemopoetic transplantExercise

Outcome Measures

Primary Outcomes (3)

  • Physical performance.

    At 6 weeks

  • Quality of Life.

    At 6 weeks

  • Anthropometry and Grip strength

    At 6 weeks

Secondary Outcomes (2)

  • Heart Rate.

    At 6 weeks

  • No adverse events during treatment.

    At 6 weeks

Study Arms (3)

Aerobic exercise plus resistance

ACTIVE COMPARATOR

Aerobic exercise plus resistance exercise for 6 weeks

Procedure: aereobic plus resisted exercise

Aerobic exercise

ACTIVE COMPARATOR

Aerobic exercise for 6 weeks

Procedure: aerobic plus active exercise

Control

OTHER

No formal exercise and weekly phone calls

Other: No formal exercise plus phone calls

Interventions

aereobic plus resisted exercisePROCEDURE
Aerobic exercise plus resistance
aerobic plus active exercisePROCEDURE
Aerobic exercise
No formal exercise plus phone callsOTHER
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • febrile neutropenia Have active graft versus host disease Have cardiomyopathy (ejection fraction \< 20%) require \> 28% oxygen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred hospital Physiotherapy dept,

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Hematologic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBehavior

Study Officials

  • Catherine M Walsh, dip. physio

    Bayside Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

November 1, 2003

Primary Completion

December 1, 2009

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

AU(1)