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Completed

NCT Number: NCT02715921

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

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.

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Key information

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Exercise and Genomics Research Center

Irvine, California, 92697, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tele-exercise

Other

Primary outcomes

  1. Habitual activity

    Time frame: 7 days

    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.

Secondary outcomes

  1. Peak oxygen consumption

    Time frame: 30 minutes

    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.

  2. Cystic fibrosis quality of life survey

    Time frame: 50 minutes

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

  3. System usability survey

    Time frame: 10 minutes

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

Sponsors and collaborators

Lead sponsor

MemorialCare Health System

Other

Collaborators

  • University of California, Irvine

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2016
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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