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Exercise Training for Blood Cancers Survivorship (S-POP Trial)

N/A
Recruiting
Led By Anthony Sung, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Providing post-discharge care for the patient who has undergone HCT
Within 90 ± 30 days post allogenic HCT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (week 12), 1 year
Awards & highlights

S-POP Trial Summary

This trial will investigate the effects of high-intensity interval training and resistance training on physical function, cognitive function, mental health, and quality of life in patients who have undergone hematopoietic stem cell transplant, as well as in the caregivers of these patients.

Who is the study for?
This trial is for English-speaking adults over 18 who have had a hematopoietic stem cell transplant (HCT) within the last 60 to 120 days, as well as their caregivers. It's designed to help improve various aspects of health post-transplant.Check my eligibility
What is being tested?
The study is testing a program that includes high-intensity interval training (HIIT) and resistance exercises over a period of 12 weeks. The goal is to see how this exercise regimen affects physical function, cognitive abilities, mental health, and overall quality of life after HCT.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects from intense exercise programs like HIIT may include muscle soreness, fatigue, and an increased risk of injury if not properly supervised or executed.

S-POP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking care of someone who has had a stem cell transplant.
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I had a bone marrow transplant from a donor within the last 60 to 120 days.
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I am 18 years old or older.

S-POP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (week 12), 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (week 12), 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to prescribed exercise program, as measured by number of total sessions completed
Compliance to prescribed HIIT sessions, as measured by number of intervals completed
Compliance to prescribed HIIT sessions, as measured by number/percentage of intervals meeting target heart rates
+3 more
Secondary outcome measures
Change in biomarkers of inflammation and frailty, as measured by blood plasma samples
Change in caregiver support, as measured by Caregiver Strain index
Change in caregiver support, as measured by Ego Resiliency
+59 more

S-POP Trial Design

2Treatment groups
Experimental Treatment
Group I: PatientExperimental Treatment1 Intervention
These are patients who are 90 (±30) days post-allogeneic hematopoietic stem cell transplant. Patients will complete 12 weeks of exercise training. Patients will also complete assessments to evaluate physical function, cognitive function, mental health, social support, nutrition and diet, symptoms, quality of life, and financial status. They will use devices to capture activity data and vital signs. They will collect bio-specimens to assess microbiota and biomarkers.
Group II: CaregiverExperimental Treatment1 Intervention
These are the assigned caregivers for the transplant patients. Caregivers will complete 12 weeks of exercise training. Caregivers will also complete assessments to evaluate physical function, caregiver support, and physical activity and exercise. They will collect bio-specimens to assess microbiota.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise training
2019
Completed Phase 1
~1170

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,409,031 Total Patients Enrolled
Anthony Sung, MDPrincipal InvestigatorDuke University
9 Previous Clinical Trials
632 Total Patients Enrolled

Media Library

Exercise training Clinical Trial Eligibility Overview. Trial Name: NCT05238376 — N/A
Blood Cancers Research Study Groups: Patient, Caregiver
Blood Cancers Clinical Trial 2023: Exercise training Highlights & Side Effects. Trial Name: NCT05238376 — N/A
Exercise training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05238376 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently an opportunity for participants to join this investigation?

"Affirmative. Based on the information housed by clinicaltrials.gov, this study is actively recruiting participants and was last modified on October 5th 2022. 70 people need to be recruited from 1 medical site for full participation in the trial."

Answered by AI

Does this clinical trial accept patients of age 25 and up?

"According to the requirements for entry, participants must be aged between 18 and 80 in order to take part."

Answered by AI

Are the criteria for enrolment in this trial compatible with my qualifications?

"The trial is accepting 70 adults (aged 18 to 80) with hematologic neoplasms. To be eligible, participants must meet the following conditions: speaking English fluently; having undergone allogenic HCT within 90 ± 30 days prior to enrollment; providing post-discharge care for a patient who has received HCT and being both a patient and caregiver."

Answered by AI

How many participants are involved in the current experiment?

"Indeed, the data hosted on clinicaltrials.gov confirms that this medical investigation is recruiting volunteers as of now, having been initially advertised on November 1st 2022 and edited most recently on October 5th 2022. The study requires 70 participants to be sourced from 1 centre."

Answered by AI
~24 spots leftby Dec 2024