Recruiting

Exercise Intervention

Sponsor:

Indiana University

Code:

NCT04265638

Conditions

Long-term Effects Secondary to Cancer Therapy in Adults

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 15 - 39

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

Brief summary:

Adolescent and young adult (AYA) survivors of cancer face a future of persistent medical issues across a wide spectrum of diseases One study examining health data from this cohort (ages 15-29) reported significantly higher rates of smoking, obesity, cardiovascular disease, hypertension, asthma, and poorer mental health among the cancer survivors when compared to healthy controls. Prescribed exercise has broad and far-reaching beneficial physiological effects that cut across multiple body systems and consistently improves emotional well-being, decreases fatigue and depression, and enhances quality of life. Although a growing body of evidence consistently demonstrates the physiological and psychological benefits of exercise interventions in adults with cancer, there are no studies examining the effects of individualized, prescribed, supervised exercise in pediatric, adolescent and young adult cancer survivors.

Conditions

Long-term Effects Secondary to Cancer Therapy in Adults

Pediatric Cancer

Study ID

NCT04265638

Start date

Jun 5, 2019

Status verified date

Nov, 2023

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 15 and ≤ 39 years,
2. History of cancer
3. At least three months off of cytotoxic chemotherapy (note: hormone therapy is permitted)

Exclusion Criteria:

1. Evidence of significant liver dysfunction, congestive heart failure, cardiovascular disease
2. History of CNS tumor
3. Down's Syndrome
4. Unable to perform aerobic and/or strength exercises with full range of motion (limb immobilization, limb amputation, or surgical complications.
5. Neurological disorder
6. Baseline exercise of 30 minutes per day three times a week already being performed.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exercise

no intervention: Usual Care

Interventions

Exercise

One on one exercise with a cancer exercise specialist 1 hour 3 times a week for 12 weeks.

Primary outcome measure

  • Change of the Participant Evaluation of Feasibility and Acceptability Questionnaire [ Time Frame: weeks 12 and 24 ]
  • Change of Balance Assessment [ Time Frame: baseline, weeks 6, 12, and 24 ]
  • Change of Cardiovascular Systems - VO2 Peak (mL·kg-1·min-1) [ Time Frame: baseline, weeks 6, 12, and 24 ]
  • Change of Cardiovascular Systems - FEV1 [ Time Frame: baseline, weeks 6, 12, and 24 ]
  • Change of Cardiovascular Systems - FCV [ Time Frame: baseline, weeks 6, 12, and 24 ]
  • Change of Fatigue [ Time Frame: baseline, weeks 6, 12, and 24 ]
  • Change of Neuropathy 15-17 year olds [ Time Frame: baseline, weeks 6, 12, and 24 ]
  • Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FEV1 [ Time Frame: baseline, weeks 6, 12, and 24 ]
  • Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FVC [ Time Frame: baseline, weeks 6, 12, and 24 ]
  • Change of Cancer Therapy Fatigue [ Time Frame: baseline, weeks 6, 12, and 24 ]
  • Change of Neuropathy over 17 years of age [ Time Frame: baseline, weeks 6, 12, and 24 ]

Central Contacts and Locations

Central contacts

NiCole Keith, PhD

317-278-8438nkeith@iupui.edu

Locations

IU Health North Hospital

Recruiting

Carmel, Indiana, United States, 46032

Contacts

NiCole Keith, PhD

317-278-8438nkeith@iupui.edu

Riley Hospital for Children - Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

NiCole Keith, PhD

317-278-8438nkeith@iupui.edu

Indianapolis Healthplex

Recruiting

Indianapolis, Indiana, United States, 46222

Contacts

Adnan Hyder

317-920-7400ahyder@indianapolishealthplex.com

More Information

Sponsor

Indiana University

Last update posted

Nov 28, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2023-11-28.