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

NCT ID: NCT02715921

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2019-05-07

Brief 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.

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cystic fibrosis patients

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

Group Type: EXPERIMENTAL

Tele-exercise

Intervention Type: OTHER

Interventions

Tele-exercise

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: collaborator

MemorialCare Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jen Jen Chen, MD

Role: PRINCIPAL_INVESTIGATOR

MemorialCare

Locations

Pediatric Exercise and Genomics Research Center

Irvine, California, United States

Countries

United States

Other Identifiers

277-13

Identifier Type: -

Identifier Source: org_study_id