- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07222345
Feasibility of High Intensity Interval Training in Survivors of Childhood, Adolescent, and Young Adult Hodgkin Lymphoma
This pilot study evaluates the feasibility of a 12-week high intensity interval training (HIIT) program in survivors of childhood, adolescent, and young adult Hodgkin lymphoma within 24 months of completing treatment. Preliminary efficacy of the HIIT intervention for improved cardiorespiratory fitness, body composition, physical function, autonomic response to exercise, peripheral neuropathy, biological aging markers, and physical activity will also be evaluated.
Primary Objective:
To determine the feasibility of a 12-week high intensity interval training (HIIT) program in survivors of childhood, adolescent, and young adult Hodgkin lymphoma within 24 months of completing treatment.
Feasibility will be assessed by:
- Participation Rate: Number of eligible survivors approached who enroll.
- Completion Rate: Number of scheduled HIIT sessions attended and number of enrolled participants who complete post-intervention testing.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amy Berkman, MD
- Phone Number: 888-226-4343
- Email: referralinfo@stjude.org
Study Locations
-
-
Tennessee
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Memphis, Tennessee, United States, 38105
- Recruiting
- St. Jude Children's Research Hospital
-
Contact:
- Amy Berkman, MD
- Phone Number: 888-226-4343
- Email: referralinfo@stjude.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant has been diagnosed with Hodgkin lymphoma between the ages of 10 to 25 years.
- Participant is between the ages of >10 and <25 years old the time of enrollment.
- Participant has completed treatment (end of chemotherapy for those not receiving radiation therapy or end of radiation therapy) for Hodgkin lymphoma within 24 months prior to enrollment and recovered from any acute treatment-related adverse events.
- Participant has been medically cleared to participate in physical activity.
- Participant verbalizes understanding of directions for use of the web-based platform on the study provided iPad and heart rate monitor.
Exclusion Criteria:
- Participant has evidence of relapsed disease.
- Participant has a diagnosis of acute heart failure.
- Participant reports currently participating in HIIT training or >420 minutes per week of moderate to vigorous physical activity.
- Female participant who is currently pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HIIT Intervention Group
Participants will complete a 12-week HIIT program with three 25-minute sessions per week.
Each session includes warm-up, five cycles of high-intensity intervals (80-95% peak HR) and recovery periods (50-60% peak HR), and cool-down.
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Participants will complete a 12-week HIIT program with three 25-minute sessions per week.
Each session includes warm-up, five cycles of high-intensity intervals (80-95% peak HR) and recovery periods (50-60% peak HR), and cool-down.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation rate (percent of eligible participants approached who enroll)
Time Frame: Trial completion (12 weeks)
|
Descriptive statistics will be reported
|
Trial completion (12 weeks)
|
|
Completion rate (percentage of scheduled HIIT sessions attended and percentage of post-intervention testing sessions completed)
Time Frame: Trial completion (12 weeks)
|
Descriptive statistics will be reported
|
Trial completion (12 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiorespiratory fitness (VO2peak, ml/kg/min)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Ewing battery score of autonomic function (0 to 5 points)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Hand grip strength (kg)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Knee extension strength (N/kg)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Modified total neuropathy scale (0 to 24 points)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
DNA methylation
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Mitochondrial DNA copy number
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Telomere length (kb)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
High-sensitivity C-reactive protein (mg/L)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Interleukin-6 (pg/mL)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Physical activity (kilocalories per week)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Body mass index (weight and height will be combined to report body mass index in kg/m2)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Percent body fat (%)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Lean mass percentage (%)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
|
Visceral fat level (score)
Time Frame: baseline at study entry, 12 weeks
|
Descriptive statistics of the change between baseline and 12 weeks will be reported
|
baseline at study entry, 12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amy Berkman, MD, St. Jude Children's Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma
- Hemic and Lymphatic Diseases
- Hodgkin Disease
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Conditioning, Human
- Exercise
- High-Intensity Interval Training
Other Study ID Numbers
- FITHOD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Recurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage III Childhood Hodgkin Lymphoma | Stage IV Childhood Hodgkin Lymphoma | Stage I Childhood Hodgkin Lymphoma | Stage II Childhood Hodgkin Lymphoma | Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma | Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma | Childhood Mixed Cellularity... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland, Israel
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