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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04021446
Other study ID # AYA_ASCEND
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2019
Est. completion date September 2024

Study information

Verified date September 2021
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2024
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: - AYA cancer survivors (18-39) Must be 12 months after treatment No metastatic disease Exclusion Criteria: - Metastatic disease Pregnancy

Study Design


Intervention

Other:
Exercise
personalized exercise prescription

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiometabolic health - Insulin Resistance insulin resistance estimated by HOMA from a fasting blood sample change from baseline to 4 months, to 8 months to 1 year
Primary Cardiometabolic health - metabolic syndrome waist circumference markers of metabolic syndrome, waist circumference via measuring tape (cm) change from baseline to 4 months, to 8 months to 1 year
Primary Cardiometabolic health - metabolic syndrome blood pressure markers of metabolic syndrome, blood pressure via Omron cuff (mmHg) change from baseline to 4 months, to 8 months to 1 year
Secondary Body Composition fat mass and lean mass via DEXA (reported in lbs) change from baseline to 4 months, to 8 months to 1 year
Secondary Cardiorespiratory fitness (Physical Fitness) cardiorespiratory fitness via submaximal VO2 max (reported via ml/kg/min) change from baseline to 4 months, to 8 months to 1 year
Secondary Muscular Strength (Physical Fitness) muscle strength through multiple repetition maximum (lbs) change from baseline to 4 months, to 8 months to 1 year
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