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

NCT04236154 | Completed Phase 1

• 2 other identifiers: 19-007775NCI-2020-00367
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Exercise, Falls

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Pedometer OTHER

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 OTHER

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 OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of non-melanoma skin cancer
• Unstable angina
• Loss of limb, which limits exercise capabilities at the discretion of the Principal Investigators
• Pregnant women

Sponsors & Collaborators

• Mayo Clinic: lead
• Andersen Foundation: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Aminah Jatoi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigator will incrementally increase the exercise prescription for groups of patients.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 22, 2020
• Study Start: September 3, 2020
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (1)