Clinical trial NCT06083324: EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Cancer
Official title: EXERT-C: Prospective Study of an EXErcise Regimen Designed to Improve Functional Mobility, Body Composition, and Strength After Treatment for Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: exercise
resistance training
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with cancer on an exercise program at the AHN Exercise Oncology and Resiliency Center

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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis
timeFrame: 3 months
measure: Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via ultrasound
timeFrame: 3 months
measure: Determine changes in muscle mass in pounds from before to after the nutrition and exercise regimen
timeFrame: 3 months
Secondary outcomes:
measure: Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen
timeFrame: 3 months
measure: Determine changes in Y-balance score for each leg
timeFrame: 3 months
measure: Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen
timeFrame: 3 months
measure: Determine changes in EQ-5D responses 1-5 and overall score from before to after the nutrition and exercise regimen
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: AHN CI Exercise Oncology and Resiliency Center
state: Pennsylvania
Study officials:
References:
citation: 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.