Cardiometabolic DysregulationASCENDNCT04021446
A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer
A study testing Exercise in people with Cardiometabolic Dysregulation and Young Adult Cancer, run by University of Southern California.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cardiometabolic Dysregulation, Young Adult Cancer, Adolescent Cancer
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- AYA cancer survivors (18-39) Must be 12 months after treatment No metastatic disease
Who cannot join
- Metastatic disease Pregnancy
About this study
Official title: 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.
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
personalized exercise prescription
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Will receive the exercise intervention Receives: Other: Exercise |
| Attention Control | No intervention | Will not receive the exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiometabolic health - Insulin Resistance
insulin resistance estimated by HOMA from a fasting blood sample
Measured: 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)
Measured: 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)
Measured: change from baseline to 4 months, to 8 months to 1 year
Secondary outcomes (3)
Body Composition
fat mass and lean mass via DEXA (reported in lbs)
Measured: change from baseline to 4 months, to 8 months to 1 year
Cardiorespiratory fitness (Physical Fitness)
cardiorespiratory fitness via submaximal VO2 max (reported via ml/kg/min)
Measured: change from baseline to 4 months, to 8 months to 1 year
Muscular Strength (Physical Fitness)
muscle strength through multiple repetition maximum (lbs)
Measured: change from baseline to 4 months, to 8 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic DysregulationStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Dieli-Conwright, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021446
- Sponsor's protocol ID
- AYA_ASCEND
- Acronym
- ASCEND
- Status last verified
- Sep 2021
- First submitted
- 12 Mar 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of Adolescent and Young Adult Cancer: The ACSEND Trial
- ClinicalTrials.gov ID
- NCT04021446
- Acronym / sponsor ID
- ASCEND / AYA_ASCEND
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Other: ExerciseWill receive the exercise intervention |
| Attention Control | No intervention | –Will not receive the exercise intervention |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- AYA cancer survivors (18-39) Must be 12 months after treatment No metastatic disease
Key exclusion criteria (1 listed)
- Metastatic disease Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisepersonalized exercise prescription | Other | Exercise |
Primary outcome
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
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)
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)
3 secondary outcomes
Body Composition
Time frame: 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
Muscular Strength (Physical Fitness)
Time frame: change from baseline to 4 months, to 8 months to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cardiometabolic Dysregulation and Young Adult Cancer, run by University of Southern California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiometabolic health - Insulin Resistance (time frame: change from baseline to 4 months, to 8 months to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.