NCT04021446

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

4 years

First QC Date

March 12, 2019

Last Update Submit

September 27, 2021

Conditions

Cardiometabolic DysregulationYoung Adult CancerAdolescent CancerBody Composition

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Body Composition

    change from baseline to 4 months, to 8 months to 1 year

  • Cardiorespiratory fitness (Physical Fitness)

    change from baseline to 4 months, to 8 months to 1 year

  • Muscular Strength (Physical Fitness)

    change from baseline to 4 months, to 8 months to 1 year

Study Arms (2)

Exercise

ACTIVE COMPARATOR

Will receive the exercise intervention

Other: Exercise

Attention Control

NO INTERVENTION

Will not receive the exercise intervention

Interventions

ExerciseOTHER

personalized exercise prescription

Exercise

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Metastatic disease Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Research

Study Record Dates

First Submitted

March 12, 2019

First Posted

July 16, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

September 29, 2021

Record last verified: 2021-09