"Prescribing" Exercise to Cancer Patients at High-Risk for Falls
Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04236154
Collaborator
Andersen Foundation (Other)
72
1
29.4
2.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
We will incrementally increase the exercise prescription for groups of patients.We will incrementally increase the exercise prescription for groups of patients.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
"Prescribing" Exercise to Cancer Patients at High-Risk for Falls
Actual Study Start Date
:
Sep 3, 2020
Anticipated Primary Completion Date
:
May 15, 2022
Anticipated Study Completion Date
:
Feb 15, 2023
Outcome Measures
Primary Outcome Measures
- ABC Activities Specific Balance Confidence Scale (exploratory outcome) [Change from baseline ABC scale at 4-6 weeks]
Patient Reported Outcome 0% No confidence, 100% Complete Confidence, higher score= better outcome
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
Diagnosis of non-melanoma skin cancer
-
Unstable angina
-
Loss of limb, which limits exercise capabilities at the discretion of the Principal Investigators
-
Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- Andersen Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Aminah Jatoi, M.D.,
Principal Investigator,
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04236154
Other Study ID Numbers:
- 19-007775
First Posted:
Jan 22, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aminah Jatoi, M.D.,
Principal Investigator,
Mayo Clinic