NCT06083324

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2026

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

October 9, 2023

Last Update Submit

February 19, 2025

Conditions

Cancer

Keywords

exerciseresistance training

Outcome Measures

Primary Outcomes (3)

  • Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis

    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

    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

    Measurement on bioimpedance analysis machine (Inbody 970)

    3 months

Secondary Outcomes (4)

  • Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen

    3 months

  • Determine changes in Y-balance score for each leg

    3 months

  • Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen

    3 months

  • Determine changes in EQ-5D responses 1-5 and overall score from before to after the nutrition and exercise regimen

    3 months

Study Arms (5)

General cancer patients

All patients undergoing treatment for cancer on an exercise regimen

Other: Dose escalated resistance training

Head and neck cancer patients

All patients undergoing treatment for head and neck cancer on an exercise regime

Other: Dose escalated resistance training

Colorectal cancer patients

All patients undergoing treatment for colorectal cancer on an exercise regime

Other: Dose escalated resistance training

Pancreatic cancer patients

All patients undergoing treatment for pancreatic cancer on an exercise regime

Other: Dose escalated resistance training

Metastatic breast cancer patients

All patients undergoing treatment for metastatic breast cancer on an exercise regime

Other: Dose escalated resistance training

Interventions

Dose escalated resistance trainingOTHER

All individuals will be engaging in resistance training during and/or after their cancer treatment

Colorectal cancer patientsGeneral cancer patientsHead and neck cancer patientsMetastatic breast cancer patientsPancreatic cancer patients

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 20-89 years
  • 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.
  • Participants must be determined capable of engaging in resistance training by exercise personnel and/or study PI
  • Participants must complete an assessment by EOC staff and be determined safe to engage in the workout regimen by the study exercise personnel.
  • Individuals not deemed safe to participate in the standard EOC exercise program will be referred to physical therapy or elsewhere

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHN CI Exercise Oncology and Resiliency Center

Pittsburgh, Pennsylvania, 15202, United States

RECRUITING

Related Publications (1)

  • Champ CE, Carpenter DJ, Diaz AK, Rosenberg J, Ackerson BG, Hyde PN. Resistance Training for Patients with Cancer: A Conceptual Framework for Maximizing Strength, Power, Functional Mobility, and Body Composition to Optimize Health and Outcomes. Sports Med. 2023 Jan;53(1):75-89. doi: 10.1007/s40279-022-01759-z. Epub 2022 Sep 29.

    PMID: 36175646BACKGROUND

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Samantha Campbell

CONTACT

(412) 330-6151samantha.campbell@ahn.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 16, 2023

Study Start

February 3, 2023

Primary Completion

January 26, 2026

Study Completion

January 26, 2026

Last Updated

February 21, 2025

Record last verified: 2025-02

Locations

US(1)