CancerPhase 1NCT04236154
"Prescribing" Exercise to Cancer Patients At High-Risk for Falls
A Phase 1 study testing Pedometer, Actigraph and Perturbation Treadmill in people with Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Falls are common and catastrophic in cancer patients. Cancer patients are vulnerable to falls due to muscle loss. In prescribing exercise in a data driven manner to cancer patients, our hypothesis is this "prescription" for exercise will eventually be demonstrated to reduce the occurrence of injurious falls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Pedometer, Actigraph and Perturbation Treadmill
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2020to 26 Aug 2024
- Phase
- Phase 1
- 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
- Any cancer diagnosis, as documented in medical record, other than non-melanoma skin cancer.
- No issues such as unstable angina or loss of a limb that would preclude exercise.
Who cannot join
- Diagnosis of non-melanoma skin cancer
- Unstable angina
- Loss of limb, which limits exercise capabilities at the discretion of the Principal Investigators
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Falls are common and catastrophic in cancer patients. Cancer patients are vulnerable to falls due to muscle loss. In prescribing exercise in a data driven manner to cancer patients, our hypothesis is this "prescription" for exercise will eventually be demonstrated to reduce the occurrence of injurious falls.
- Conditions
- Cancer
- Being tested
- Pedometer, Actigraph, Perturbation Treadmill
- Keywords
- Exercise, Falls
- 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.
PedometerOther
Participants will wear a pedometer for 4 days at baseline, and 4-6 weeks later. Baseline readings will be used to derive an individualized exercise program for each participant based on the assigned experimental arm.
ActigraphOther
Participants will wear a Actigraph for 4 days at baseline and 4-6 weeks later. Baseline readings will be used to derive an individualized exercise program for each participant based on the assigned experimental arm.
Perturbation TreadmillOther
Participants will walk on an instrumented treadmill while wearing a safety harness at baseline and 4-6 weeks later. The perturbation treadmill will assess an individual's risk for falling. Baseline readings will be used to derive an individualized exercise program for each participant based on the assigned experimental arm.
What is being measured
The primary outcome is the main question the study is designed to answer.
ABC Activities Specific Balance Confidence Scale (exploratory outcome)
Patient Reported Outcome 0% No confidence, 100% Complete Confidence, higher score= better outcome
Measured: Change from baseline ABC scale at 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start3 Sep 2020
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigator will incrementally increase the exercise prescription for groups of patients.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Andersen Foundation
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236154
- Sponsor's protocol ID
- 19-007775
- Other IDs
- NCI-2020-00367
- Status last verified
- Oct 2024
- First submitted
- 16 Jan 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Prescribing" Exercise to Cancer Patients At High-Risk for Falls
- ClinicalTrials.gov ID
- NCT04236154
- Acronym / sponsor ID
- 19-007775
- Conditions
- Cancer
- Keywords
- Exercise, Falls
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Andersen Foundation
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 22 Jan 2020 (actual)
- 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.
Falls are common and catastrophic in cancer patients. Cancer patients are vulnerable to falls due to muscle loss. In prescribing exercise in a data driven manner to cancer patients, our hypothesis is this "prescription" for exercise will eventually be demonstrated to reduce the occurrence of injurious falls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- The investigator will incrementally increase the exercise prescription for groups of patients.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any cancer diagnosis, as documented in medical record, other than non-melanoma skin cancer.
- No issues such as unstable angina or loss of a limb that would preclude exercise.
Key exclusion criteria (4 listed)
- Diagnosis of non-melanoma skin cancer
- Unstable angina
- Loss of limb, which limits exercise capabilities at the discretion of the Principal Investigators
- Pregnant women
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 |
|---|---|---|
| PedometerParticipants will wear a pedometer for 4 days at baseline, and 4-6 weeks later. Baseline readings will be used to derive an individualized exercise program for each participant based on the assigned experimental arm. | Other | – |
| ActigraphParticipants will wear a Actigraph for 4 days at baseline and 4-6 weeks later. Baseline readings will be used to derive an individualized exercise program for each participant based on the assigned experimental arm. | Other | – |
| Perturbation TreadmillParticipants will walk on an instrumented treadmill while wearing a safety harness at baseline and 4-6 weeks later. The perturbation treadmill will assess an individual's risk for falling. Baseline readings will be used to derive an individualized exercise program for each participant based on the assigned experimental arm. | Other | – |
Primary outcome
ABC Activities Specific Balance Confidence Scale (exploratory outcome)
Time frame: Change from baseline ABC scale at 4-6 weeks
Patient Reported Outcome 0% No confidence, 100% Complete Confidence, higher score= better outcome
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 15 Oct 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Aminah Jatoi, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pedometer, Actigraph and Perturbation Treadmill in people with Cancer, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 4 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 15 Oct 2024. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ABC Activities Specific Balance Confidence Scale (exploratory outcome) (time frame: Change from baseline ABC scale at 4-6 weeks). 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 15 Oct 2024.