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Physical Activity for Lymphoblastic Leukemia

N/A

Recruiting

Led By Andrea Orsey, MD

Research Sponsored by Connecticut Children's Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have no documented or observable psychiatric or neurological disorders that would interfere with study participation

Pediatric oncology patients with ALL in the maintenance phase of chemotherapy during the time of study

Must not have

Not receiving chemotherapy during the time of study

Age less than 8 years or greater than 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how exercise affects kids with leukemia who are receiving maintenance chemotherapy.

Who is the study for?

This trial is for children aged 8-18 with acute lymphoblastic leukemia (ALL) who are in the maintenance phase of chemotherapy, can speak and read English, have no exercise contraindications as per their oncologist, live with parents/guardians who consent to participation, and don't have psychiatric or neurological disorders affecting study involvement.

What is being tested?

The study aims to assess how moderate physical activity affects the quality of life and activity levels in pediatric patients undergoing maintenance chemotherapy for ALL. It will measure changes due to exercise during this treatment phase.

What are the potential side effects?

Since the intervention involves physical activity rather than medication, side effects may include typical exercise-related responses such as muscle soreness or fatigue but should be minimal under medical supervision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any mental or neurological conditions that would prevent me from participating.

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I am a child with ALL and currently in the maintenance phase of my treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on chemotherapy during this study.

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I am either younger than 8 or older than 18 years old.

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I am an English speaker.

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I am not a child with leukemia in the maintenance phase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Life Outcomes

Secondary study objectives

Fatigue

Physical Activity

Sleep

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Physical ActivityExperimental Treatment1 Intervention

Single arm study where patients choose from physical activities after baseline assessment by PT. Activities include the following: Nintendo WII fit console, Xbox Kinect fit console and other sport activities.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Activity

2019

Completed Phase 3

~4760

0 / 6Eligibility criteria met