CancerNCT01111032
Comparison of Two-treadmill Test Protocols to Evaluate Endurance in People With Cancer
An observational study of Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
During this study the investigators will compare the use of two treadmill tests in people diagnosed with cancer. The STEEP treadmill protocol is often used to evaluate the endurance of people diagnosed with cancer, however, since it is based on step increases in speed or ramp, it may not related to normal function. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Dec 2011
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult well cancer survivors
Who may be able to join
- Participants are required to be adults (age 16 or over),
- Diagnosed with cancer, at any stage of treatment (during or after treatment),
- Able to follow instructions in English, and provide informed consent.
- Participants need to be considered "well" to participate. A "well participant" has been defined as a cancer survivor who is living at home, able to ambulate independently without a gait aid (single point cane is acceptable), has no acute medical conditions, and passes pre-exercise safety screening.
Who cannot join
- Cancer survivors with metastatic disease.
- Cancer survivors who are defined as unwell.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Sciences, Henderson Campus
Hamilton, Ontario, L8V 1C3
About this study
Official title: Comparison of Two-treadmill Test Protocols to Evaluate Endurance in People With Cancer.
During this study the investigators will compare the use of two treadmill tests in people diagnosed with cancer. The STEEP treadmill protocol is often used to evaluate the endurance of people diagnosed with cancer, however, since it is based on step increases in speed or ramp, it may not related to normal function. The new test, which is based on the body response to increased activity has not been used with people with cancer but may provide a better approximation of endurance demands during daily function. Our question is whether the new treadmill test can be used to evaluate aerobic function with people with cancer better than the STEEP treadmill test.
- Conditions
- Cancer
- Keywords
- Treadmill, Exercise, Cancer, Validity, Reliability
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill test | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
STEEP treadmill test
Treadmill test for endurance. Lasts approx 15 min with 45 min recovery
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Oren Cheifetz, McMaster University
- Investigators
- Oren Cheifetz, M.Sc. PT, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111032
- Sponsor's protocol ID
- Treadmill Comparison
- Status last verified
- Sep 2013
- First submitted
- 26 Apr 2010
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two-treadmill Test Protocols to Evaluate Endurance in People With Cancer.
- ClinicalTrials.gov ID
- NCT01111032
- Acronym / sponsor ID
- Treadmill Comparison
- Conditions
- Cancer
- Keywords
- Treadmill, Exercise, Cancer, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Apr 2010 (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.
During this study the investigators will compare the use of two treadmill tests in people diagnosed with cancer. The STEEP treadmill protocol is often used to evaluate the endurance of people diagnosed with cancer, however, since it is based on step increases in speed or ramp, it may not related to normal function. The new test, which is based on the body response to increased activity has not been used with people with cancer but may provide a better approximation of endurance demands during daily function. Our question is whether the new treadmill test can be used to evaluate aerobic function with people with cancer better than the STEEP treadmill test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treadmill test | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult well cancer survivors
Key inclusion criteria (4 listed)
- Participants are required to be adults (age 16 or over),
- Diagnosed with cancer, at any stage of treatment (during or after treatment),
- Able to follow instructions in English, and provide informed consent.
- Participants need to be considered "well" to participate. A "well participant" has been defined as a cancer survivor who is living at home, able to ambulate independently without a gait aid (single point cane is acceptable), has no acute medical conditions, and passes pre-exercise safety screening.
Key exclusion criteria (2 listed)
- Cancer survivors with metastatic disease.
- Cancer survivors who are defined as unwell.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
STEEP treadmill test
Time frame: 1 hour
Treadmill test for endurance. Lasts approx 15 min with 45 min recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
Related trials for Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
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.
Oren Cheifetz, M.Sc. PT principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 2013. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
STEEP treadmill test (time frame: 1 hour). 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 1 Oct 2013.