Hematological MalignanciesNCT00163644
RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT
A study testing aereobic plus resisted exercise, aerobic plus active exercise and No formal exercise plus phone calls in people with Hematological Malignancies, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- aereobic plus resisted exercise, aerobic plus active exercise and No formal exercise plus phone calls
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2003to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- febrile neutropenia Have active graft versus host disease Have cardiomyopathy (ejection fraction < 20%) require > 28% oxygen
Trial locations and contacts
1 site in 1 country.
Australia1 site
Alfred hospital Physiotherapy dept,
Melbourne, Victoria, 3004
About this study
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
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.
Read the detailed description
A three group, single blinded, randomised trial was designed to compare the effects of
- aerobic plus active exercise and
- aerobic plus resistance exercise to
- control group of bone marrow/haemopoietic recipients not recieving exercise.
The hypotheses being tested is that
- Exercise improves the physical performance of transplants recipients.
- Exercise improves the quality of life of these patients;
- resisted exercise added to aerobic exercise increases muscle strength or lean muscle mass and
- There are no adverse events during either form of exercise
- Conditions
- Hematological Malignancies
- Being tested
- aereobic plus resisted exercise, aerobic plus active exercise, No formal exercise plus phone calls
- Keywords
- Hematological malignancies., Bone- marrow/ haemopoetic transplant, Exercise
- Medical subject headings
- Hematologic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aereobic plus resisted exerciseProcedure or surgery
aerobic plus active exerciseProcedure or surgery
No formal exercise plus phone callsOther
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise plus resistance | Active comparator | Aerobic exercise plus resistance exercise for 6 weeks Receives: Procedure: aereobic plus resisted exercise |
| Aerobic exercise | Active comparator | Aerobic exercise for 6 weeks Receives: Procedure: aerobic plus active exercise |
| Control | Other | No formal exercise and weekly phone calls Receives: Other: No formal exercise plus phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance.
Measured: At 6 weeks
Quality of Life.
Measured: At 6 weeks
Anthropometry and Grip strength
Measured: At 6 weeks
Secondary outcomes (2)
Heart Rate.
Measured: At 6 weeks
No adverse events during treatment.
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- The Alfred, The Leukaemia Foundation of Victoria
- Responsible party
- Sponsor
- Investigators
- Catherine M Walsh, dip. physio, Principal investigator, Bayside Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163644
- Sponsor's protocol ID
- 144/02
- Status last verified
- Jan 2016
- First submitted
- 11 Sep 2005
- Last updated
- 8 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00163644
- Acronym / sponsor ID
- 144/02
- Conditions
- Hematological Malignancies
- Keywords
- Hematological malignancies., Bone- marrow/ haemopoetic transplant, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- The Alfred, The Leukaemia Foundation of Victoria
- Study start
- Nov 2003
- Primary completion
- Dec 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
A three group, single blinded, randomised trial was designed to compare the effects of
- aerobic plus active exercise and
- aerobic plus resistance exercise to
- control group of bone marrow/haemopoietic recipients not recieving exercise.
The hypotheses being tested is that
- Exercise improves the physical performance of transplants recipients.
- Exercise improves the quality of life of these patients;
- resisted exercise added to aerobic exercise increases muscle strength or lean muscle mass and
- There are no adverse events during either form of exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise plus resistance | Active comparator | Procedure: aereobic plus resisted exerciseAerobic exercise plus resistance exercise for 6 weeks |
| Aerobic exercise | Active comparator | Procedure: aerobic plus active exerciseAerobic exercise for 6 weeks |
| Control | Other | Other: No formal exercise plus phone callsNo formal exercise and weekly phone calls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- febrile neutropenia Have active graft versus host disease Have cardiomyopathy (ejection fraction < 20%) require > 28% oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aereobic plus resisted exercise | Procedure or surgery | Aerobic exercise plus resistance |
| aerobic plus active exercise | Procedure or surgery | Aerobic exercise |
| No formal exercise plus phone calls | Other | Control |
Primary outcome
Physical performance.
Time frame: At 6 weeks
Quality of Life.
Time frame: At 6 weeks
Anthropometry and Grip strength
Time frame: At 6 weeks
2 secondary outcomes
Heart Rate.
Time frame: At 6 weeks
No adverse events during treatment.
Time frame: At 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine M Walsh, dip. physio principal investigator
Bayside Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aereobic plus resisted exercise, aerobic plus active exercise and No formal exercise plus phone calls in people with Hematological Malignancies, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical performance. (time frame: At 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.