"Prescribing" Exercise to Cancer Patients at High-Risk for Falls

Cancer Clinical Trial

Official title:

"Prescribing" Exercise to Cancer Patients at High-Risk for Falls

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04236154
• Other study ID #: 19-007775
• Secondary ID: NCI-2020-00367
• Status: Recruiting
• Phase: Phase 1
• Start date: September 3, 2020
• Est. completion date: February 15, 2025

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: Christine Huyber
• Phone: 507-266-0984
• Email: huyber.christine[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Pedometer
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.
• Actigraph
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 Treadmill
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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Andersen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABC Activities Specific Balance Confidence Scale (exploratory outcome)	Patient Reported Outcome 0% No confidence, 100% Complete Confidence, higher score= better outcome	Change from baseline ABC scale at 4-6 weeks