EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Cancer (EXERT-C)

February 19, 2025 updated by: Colin Champ, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

EXERT-C: Prospective Study of an EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Cancer

This protocol seeks to analyze patient outcomes of the standard of care, monitored group exercise regimen of high-load resistance training and functional exercises with compound movements under close supervision on individuals who have been treated for cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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 Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15202
        • Recruiting
        • AHN CI Exercise Oncology and Resiliency Center
        • Contact:
        • Contact:
          • Chris Peluso, BS

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals diagnosed with cancer on an exercise program at the AHN Exercise Oncology and Resiliency Center

Description

Inclusion Criteria:

  1. Age 20-89 years
  2. Women of child-bearing potential must verbally confirm lack of pregnancy prior to enrollment. They should also consent to use adequate contraception during the course of the study.
  3. Participants must be determined capable of engaging in resistance training by exercise personnel and/or study PI
  4. Participants must complete an assessment by EOC staff and be determined safe to engage in the workout regimen by the study exercise personnel.
  5. Individuals not deemed safe to participate in the standard EOC exercise program will be referred to physical therapy or elsewhere

Exclusion Criteria:

1. Severe arthritic, joint, cardiovascular, or musculoskeletal condition that would interfere with exercise program

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General cancer patients
All patients undergoing treatment for cancer on an exercise regimen
Other: Dose escalated resistance training
All individuals will be engaging in resistance training during and/or after their cancer treatment
Head and neck cancer patients
All patients undergoing treatment for head and neck cancer on an exercise regime
Other: Dose escalated resistance training
All individuals will be engaging in resistance training during and/or after their cancer treatment
Colorectal cancer patients
All patients undergoing treatment for colorectal cancer on an exercise regime
Other: Dose escalated resistance training
All individuals will be engaging in resistance training during and/or after their cancer treatment
Pancreatic cancer patients
All patients undergoing treatment for pancreatic cancer on an exercise regime
Other: Dose escalated resistance training
All individuals will be engaging in resistance training during and/or after their cancer treatment
Metastatic breast cancer patients
All patients undergoing treatment for metastatic breast cancer on an exercise regime
Other: Dose escalated resistance training
All individuals will be engaging in resistance training during and/or after their cancer treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis
Time Frame: 3 months
Measurement on bioimpedance analysis machine (Inbody 970)
3 months
Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via ultrasound
Time Frame: 3 months
Measurement via ultrasound and calculation with Jackson-Pollack calculations
3 months
Determine changes in muscle mass in pounds from before to after the nutrition and exercise regimen
Time Frame: 3 months
Measurement on bioimpedance analysis machine (Inbody 970)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine changes in EQ-5D responses 1-5 and overall score from before to after the nutrition and exercise regimen
Time Frame: 3 months
EQ-5D asks 5 questions rates from 1-5 and an overall rating of health
3 months
Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen
Time Frame: 3 months
Load is calculated by multiplying sets by repetitions by weight lifted for a specific exercise
3 months
Determine changes in Y-balance score for each leg
Time Frame: 3 months
Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk.
3 months
Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen
Time Frame: 3 months
Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen
3 months

Collaborators and Investigators

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

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 3, 2023

Primary Completion (Estimated)

January 26, 2026

Study Completion (Estimated)

January 26, 2026

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-021-SG

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

product manufactured in and exported from the U.S.

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.

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