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CompletedNCT04236154Updated Oct 15, 2024

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

A Phase 1 interventional study of Pedometer and Actigraph in Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Mayo Clinic · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer

Keywords

  • Exercise, Falls
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 34 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Interventions

  • OtherPedometer

    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.

  • OtherActigraph

    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.

  • OtherPerturbation 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.

06

What researchers measure

Primary outcomes

  1. ABC Activities Specific Balance Confidence Scale (exploratory outcome)

    Patient Reported Outcome 0% No confidence, 100% Complete Confidence, higher score= better outcome

    Time frame: Change from baseline ABC scale at 4-6 weeks

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04236154
Lead sponsor
Mayo Clinic
Collaborators
Andersen Foundation
Responsible party
Sponsor
First posted
Jan 22, 2020
Start date
Sep 3, 2020
Primary completion
Aug 26, 2024
Completion
Aug 26, 2024
Last update
Oct 15, 2024

Study contacts

Aminah Jatoi, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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