Clinical trial for Pulmonary Hypertension
Official title iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH
ClinicalTrials.gov ID: NCT05442671
What this study is testing
- What it's testing
- This study is testing whether a guided exercise program with wearable activity monitors can improve exercise ability and quality of life in children with pulmonary hypertension.
- Who it's for
- You may be able to join if you are a child or teenager who has pulmonary hypertension.
- What's involved
- You will wear a small activity tracker and follow an exercise plan at home for 16 weeks. You will visit the clinic a few times for check‑ins and tests.
- Time commitment
- The study lasts about four months with visits at the start, middle, and end.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18
You may be able to join if
- Age 8-18 years
- PH World Health Organization (WHO) diagnostic groups 1, 2, 3, or 4 (pulmonary arterial hypertension, PH due to left heart disease, PH due to lung...
- WHO functional class I or II
- Ambulatory status
- Mean pulmonary to systemic arterial pressure ratio \<0.75 if the patient has not undergone a pulmonary to systemic artery shunt ("Potts" shunt) OR...
You likely can't join if
- WHO functional class III or IV
- Single ventricle physiology
- Moderate to severe renal disease (\>stage 3)
- Severe hepatic impairment [aspartate aminotransferase (AST)/alanine transaminase (ALT) \> 2x upper limit of normal]
- Current pregnancy
- Significant developmental delay/inability to comply with verbal instructions to complete the study procedures
See the full eligibility criteria
- Age 8-18 years
- PH World Health Organization (WHO) diagnostic groups 1, 2, 3, or 4 (pulmonary arterial hypertension, PH due to left heart disease, PH due to lung disease, chronic thromboembolic PH)
- WHO functional class I or II
- Ambulatory status
- Mean pulmonary to systemic arterial pressure ratio \<0.75 if the patient has not undergone a pulmonary to systemic artery shunt ("Potts" shunt) OR the placement of a Potts shunt ≥ 6 months prior to study enrollment
- Stable PH medication regimen for 3 months prior to the intervention
- Home Wifi connection
- Mobile device in family capable of receiving text messages
- WHO functional class III or IV
- Single ventricle physiology
- Moderate to severe renal disease (\>stage 3)
- Severe hepatic impairment [aspartate aminotransferase (AST)/alanine transaminase (ALT) \> 2x upper limit of normal]
- Current pregnancy
- Significant developmental delay/inability to comply with verbal instructions to complete the study procedures
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.