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

September 27, 2021 updated by: Christina Dieli-Conwright, University of Southern California

A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of Adolescent and Young Adult Cancer: The ACSEND Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Metastatic disease Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Exercise
Will receive the exercise intervention
Other: Exercise
personalized exercise prescription
NO_INTERVENTION: Attention Control
Will not receive the exercise intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2019

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

September 1, 2024

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

July 12, 2019

First Posted (ACTUAL)

July 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • AYA_ASCEND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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