A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer

Not Applicable

Withdrawn

• Conditions: Cardiometabolic Dysregulation; Young Adult Cancer; Adolescent Cancer; Body Composition

• Registration Number: NCT04021446
• Lead Sponsor: University of Southern California

Brief Summary

The main goal of this clinical trial is to use a novel exercise intervention to improve cardiometabolic and biopsychosocial health outcomes in overweight/obese sedentary survivors of AYA cancers at risk for chronic comorbid conditions. The investigator's hypothesis is that an exercise intervention will improve: cardiometabolic health; body composition; physical fitness and biopsychosocial outcomes when compared to the attention control group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-16
• Study Start: 2019-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29
• Primary Completion: 2023-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• AYA cancer survivors (18-39) Must be 12 months after treatment No metastatic disease

Exclusion Criteria

• Metastatic disease Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiometabolic health - Insulin Resistance	change from baseline to 4 months, to 8 months to 1 year	insulin resistance estimated by HOMA from a fasting blood sample
Cardiometabolic health - metabolic syndrome blood pressure	change from baseline to 4 months, to 8 months to 1 year	markers of metabolic syndrome, blood pressure via Omron cuff (mmHg)
Cardiometabolic health - metabolic syndrome waist circumference	change from baseline to 4 months, to 8 months to 1 year	markers of metabolic syndrome, waist circumference via measuring tape (cm)

Secondary Outcome Measures

Name	Time	Method
Muscular Strength (Physical Fitness)	change from baseline to 4 months, to 8 months to 1 year	muscle strength through multiple repetition maximum (lbs)
Body Composition	change from baseline to 4 months, to 8 months to 1 year	fat mass and lean mass via DEXA (reported in lbs)
Cardiorespiratory fitness (Physical Fitness)	change from baseline to 4 months, to 8 months to 1 year	cardiorespiratory fitness via submaximal VO2 max (reported via ml/kg/min)