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

Cancer Clinical Trial

— EXERT-C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083324
• Other study ID #: 2023-021-SG
• Status: Recruiting
• Start date: February 3, 2023
• Est. completion date: May 3, 2024

Study information

• Verified date: October 2023
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: Samantha Campbell
• Phone: (412) 330-6151
• Email: samantha.campbell[@]ahn.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 3, 2024
• Est. primary completion date: February 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Dose esclated resistance training
All individuals will be engaging in resistance training during and/or after their cancer treatment

Locations

Country	Name	City	State
United States	AHN CI Exercise Oncology and Resiliency Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Country where clinical trial is conducted

United States, 

Outcome

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