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

NCT ID: NCT04236154

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-03

Study Completion Date

2024-08-26

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The investigator will incrementally increase the exercise prescription for groups of patients.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Andersen Foundation

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aminah Jatoi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2020-00367

Identifier Type: OTHER

Identifier Source: secondary_id

19-007775

Identifier Type: -

Identifier Source: org_study_id

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