← Back to Search

Home exercise intervention for 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

iTONE Trial 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.Check my eligibility

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.See study design

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.

iTONE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in moderate to vigorous physical activity (MVPA)

Secondary outcome measures

Change in 6-minute walk test distance

Change in leg lean mass Z-score (LLMZ)

Change in muscle strength

+1 more

iTONE 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

2015

Completed Phase 4

~2150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,841 Previous Clinical Trials

47,814,317 Total Patients Enrolled

Children's Hospital of PhiladelphiaLead Sponsor

709 Previous Clinical Trials

8,583,070 Total Patients Enrolled

Frequently Asked Questions

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

What is the cumulative count of individuals participating in this medical study?

"Indeed, the details on clinicaltrials.gov indicate that this investigation is currently seeking subjects. Originally shared on 4/3/2024 and last modified on the same date, the experiment aims to recruit 25 individuals from a single location."

Answered by AI

Is the clinical trial open to individuals older than 20 years of age?

"Eligible candidates for this research study must fall between the ages of 8 and 18. In total, there are 50 trials available for individuals under 18 years old and a substantial number of 663 trials catering to those aged over 65."

Answered by AI

Can individuals such as myself participate in this clinical study?

"This research is seeking 25 individuals aged between 8 and 18 who have pulmonary hypertension. Essential conditions for eligibility include being able to walk, showing oxygen saturation above 85% during a six-minute exercise test, falling within the specified age range, having been diagnosed with specific types of pulmonary hypertension according to WHO guidelines (groups 1, 2, or 3), being categorized as WHO functional class I or II, presenting with a mean ratio of pulmonary arterial pressure compared to systemic arterial pressure below 0.75 in the latest cardiac catheterization results, and maintaining a consistent regimen of medications for pulmonary hypertension over the past three months"

Answered by AI

Is this research study currently accepting new participants?

"Indeed, information available on clinicaltrials.gov affirms that this medical investigation is actively enrolling volunteers. The trial was initially publicized on April 3rd, 2024 and last revised on the same day. The study aims to recruit a total of 25 participants from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH

2024. "iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05442671.

All > Pulmonary Hypertension