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

NCT02715921 | Completed

• 1 other identifier: 277-13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

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.

  7 days

Secondary Outcomes (3)

• Peak oxygen consumption

  30 minutes

• Cystic fibrosis quality of life survey

  50 minutes

• System usability survey

  10 minutes

Study Arms (1)

Cystic fibrosis patients

EXPERIMENTAL

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

Other: Tele-exercise

Interventions

Tele-exercise OTHER

Cystic fibrosis patients

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MemorialCare Health System: lead
• University of California, Irvine: collaborator

Study Sites (1)

Pediatric Exercise and Genomics Research Center

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Jen Jen Chen, MD

  MemorialCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: March 22, 2016
• Study Start: January 1, 2015
• Primary Completion: April 25, 2019
• Study Completion: May 7, 2019
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)