ClinicalTrials.gg
CompletedNCT02715921Updated Jul 30, 2026

Impact of Telerehabilitation Training on Pediatric Cystic Fibrosis Patients: An Exploratory Study

An interventional study of Tele-exercise in Cystic Fibrosis, sponsored by MemorialCare Health System. Completed at 1 site in United States. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by MemorialCare Health System · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2015, registered Jan 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
8 Years to 21 Years
Sex
All
01

Study 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.

Read the detailed description

The advent of ubiquitous computing has transformed the landscape of healthcare delivery. Thus far, exercise training in CF have either required patients travel to a gym or relied on home visits or telephone calls. Virtual visits provide a novel and innovative platform to deliver a live stream of exercise sessions with two-way video and audio capabilities, allowing individualized attention to exercise for CF patient from the comfort and privacy of their homes. Applications of tele-exercise, or tele-rehabilitation, have been shown to be as effective as in conventional physical therapy following orthopedic surgeries and, in stroke patients, to optimize patient outcome by prolonging duration of treatment and preventing the observed decline after the termination of therapy. For CF patients, the latter is especially important given the impact of hospitalizations for acute exacerbations on exercise tolerance. In this particular population, where cross-contamination risks limit use of group exercise activity, using two-way video telecommunication allows participation in exercise programs while adhering to the standards of CF management regarding infection control.

This study would be the first to evaluate implementing tele-exercise and remote monitoring program on pediatric CF patients. Pediatric CF patients will be enrolled in a six-week exercise program that is streamed live from an instructor into their computers at home via a HIPAA compliant telemedicine platform. Remote monitoring devices, such as accelerometers and wireless heart rate monitors, will evaluate baseline habitual activity and intensity of exercise, respectively. The goal of this study is to show that tele-exercise program is a feasible and convenient and cost-effective method to enhance CF care.

02

Conditions studied

  • Cystic Fibrosis

Browse trials for

03

In context

Cystic Fibrosis

1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.

This study's enrollment of 10 is below the median of 36 across 1,051 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

MemorialCare Health System is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

Exclusion criteria

  • \< 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 (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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Cystic fibrosis patients

    Receive tele-exercise training and undergo pulmonary function testing and exercise testing

    Other: Tele-exercise

Interventions

  • OtherTele-exercise
06

What researchers measure

Primary outcomes

  1. Habitual activity

    An Actigraph accelerometer will be worn by the participant during waking hours for the first week and last week of the exercise program to assess habitual activity.

    Time frame: 7 days

Secondary outcomes

  1. Peak oxygen consumption

    The patient will exercise on a cycle ergometer, using a ramp protocol in which the resistance is increased by 10-20 watts per minute, until exhaustion. During this test, breath by breath measurements of physiological parameters (oxygen saturation, carbon dioxide levels, respiratory rate, heart rate) will be measured. From these measurements, we will extrapolate VO2 (oxygen consumption) at its peak, which is when the participant reaches his or her highest level of exertion.

    Time frame: 30 minutes

  2. Cystic fibrosis quality of life survey

    Approximately 50 questions related to quality of life in Cystic fibrosis.

    Time frame: 50 minutes

  3. System usability survey

    A ten question survey related to system usability. Answers for these questions range from 0 (strongly disagree) to 4 (strongly agree)

    Time frame: 10 minutes

07

Study locations

1 site
  • Pediatric Exercise and Genomics Research Center
    Irvine, California 92697, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02715921
Lead sponsor
MemorialCare Health System
Responsible party
Sponsor
First posted
Mar 22, 2016
Start date
Jan 1, 2015
Primary completion
Apr 25, 2019
Completion
May 7, 2019
Last update
Jul 30, 2026

Study contacts

Jen Jen Chen, MD
principal investigator · MemorialCare

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion