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

September 25, 2023 updated by: Mayo Clinic
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline ABC scale at 4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Andersen Foundation

Investigators

  • Principal Investigator: Aminah Jatoi, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2020

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 20, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19-007775
  • NCI-2020-00367 (Other Identifier: CTRP (Clinical Trials Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Pedometer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe