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

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT06083324

Collaborator

(none)

100

Enrollment

Location

14.9

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: Dose esclated resistance training

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 3, 2023

Anticipated Primary Completion Date :

Feb 3, 2024

Anticipated Study Completion Date :

May 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
General cancer patients All patients undergoing treatment for cancer on an exercise regimen	Other: Dose esclated 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 esclated 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 esclated 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 esclated 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 esclated resistance training All individuals will be engaging in resistance training during and/or after their cancer treatment

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen [3 months]
Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen
Determine changes in Y-balance score for each leg [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.
Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen [3 months]
Load is calculated by multiplying sets by repetitions by weight lifted for a specific exercise
Determine changes in EQ-5D responses 1-5 and overall score from before to after the nutrition and exercise regimen [3 months]
EQ-5D asks 5 questions rates from 1-5 and an overall rating of health

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AHN CI Exercise Oncology and Resiliency Center	Pittsburgh	Pennsylvania	United States	15202

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT06083324

Other Study ID Numbers:

2023-021-SG

First Posted:

Oct 16, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

exercise

resistance training

Study Results

No Results Posted as of Oct 16, 2023