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Exercise Program for Pediatric Pulmonary Hypertension (iTONE Trial)

N/A

Recruiting

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-exercise intervention and post intervention (within 2 weeks of completion of the 16-week exercise intervention)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to help children and teenagers with pulmonary hypertension (PH) be more active and improve their muscle strength. Previous studies have shown that children with PH are less active and have weaker muscles compared to

Who is the study for?

The iTONE Trial is for children and teenagers aged 8-18 with pulmonary hypertension (PH), who can walk, have an oxygen saturation over 85% during a walking test, and are in the early stages of their condition. They should not have severe PH and must be on stable medication for at least three months.

What is being tested?

This study tests a 16-week exercise program using wearable activity monitors to increase physical activity and muscle mass, which may improve exercise performance and quality of life in young patients with PH.

What are the potential side effects?

Since this trial involves an exercise intervention rather than medication, side effects might include typical exercise-related issues such as muscle soreness or fatigue but will be closely monitored given the participants' conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-exercise intervention and post intervention (within 2 weeks of completion of the 16-week exercise intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-exercise intervention and post intervention (within 2 weeks of completion of the 16-week exercise intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-exercise intervention and post intervention (within 2 weeks of completion of the 16-week exercise intervention) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in moderate to vigorous physical activity (MVPA)

Secondary study objectives

Change in 6-minute walk test distance

Change in leg lean mass Z-score (LLMZ)

Change in muscle strength

+1 more

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: Home exercise interventionExperimental Treatment1 Intervention

* Personalized 16 week home exercise program - aerobic exercise for 20 minutes per day/4 days per week and light resistance exercise using resistance bands 3 days per week. * Aerobic sessions will include walking, biking, or light jogging, depending on access to facilities/equipment and weather. * Smartwatch for the length of the intervention and a heart rate monitor during exercise sessions. * Max heart rate prescribed will be 80% of that on recent cardiopulmonary exercise test (at most 150 beats/min). * Heart rate monitor will sync with the smartwatch. * Activity and heart rate data will be transmitted to the study team via a data hub connected to the participant's home internet modem several times per week. * Periodic text messaging to remind participants to wear the watch, sync the data, or adhere to heart rate goals, to ask about symptoms, or to support activity progress. * Multiple ways to contact the study team with questions or concerns.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise intervention

2010

Completed Phase 4

~2160

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