Impact of Telerehabilitation Training on Pediatric Cystic Fibrosis Patients: An Exploratory Study (NCT02715921) | Clinical Trial Compass
CompletedNot Applicable
Impact of Telerehabilitation Training on Pediatric Cystic Fibrosis Patients: An Exploratory Study
United States10 participantsStarted 2015-01-01
Plain-language summary
Fitness in patients with Cystic fibrosis (CF) is an important biomarker associated with higher survivability and improved quality of life. CF patients are encouraged to maintain an active lifestyle, however, while physicians are able to prescribe airway clearance measures or specific medications, there is no prescription for exercise or avenue to promote exercise outside the clinic or hospital.
Who can participate
Age range
8 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 8 - 21 years old
* Diagnosis of Cystic Fibrosis confirmed by genetic studies and/or sweat chloride testing
* Baseline pulmonary function testing (PFT) (within the last 3 months) with FEV1 (Forced expiratory volume in 1 second) \> 40%
* Must be able to perform 3-minute step test.
* Must achieve an adequate 15 count breathlessness score. Must be able to perform ergometry testing utilizing extremities
* Must have a working computer/smartphone/tablet with internet connection at home
Exclusion criteria
* FEV1 \< 40%
* Desaturations (less than 75%) or significant fatigue with 3-minute step test 15 count breathlessness score of greater than 2
* Pulmonary exacerbation (shortness of breath or difficulty breathing requiring hospitalization) within the last 4 weeks
* Oxygen requirement at rest or during sleeping.
* Recent pneumothorax (popped lung) within last 3 months
* Moderate pulmonary hypertension (increased pressure in the lung arteries) diagnosed via echocardiogram.
* History of low ejection fraction (percentage of blood being pumped out of the heart) via echocardiogram.
* History of cardiac ischemia (reduced blood supply to heart tissue).
* Uncontrolled systemic hypertension for patient age and height.
* Moderate to severe scoliosis (abnormal curvature of the spine)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.