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

Not Applicable
Completed
Conditions
Cystic Fibrosis
Interventions
Other: Tele-exercise
Registration Number
NCT02715921
Lead Sponsor
MemorialCare Health System
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Cystic fibrosis patientsTele-exerciseReceive tele-exercise training and undergo pulmonary function testing and exercise testing
Primary Outcome Measures
NameTimeMethod
Habitual activity7 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 Outcome Measures
NameTimeMethod
Peak oxygen consumption30 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.

System usability survey10 minutes

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

Cystic fibrosis quality of life survey50 minutes

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

Trial Locations

Locations (1)

Pediatric Exercise and Genomics Research Center

🇺🇸

Irvine, California, United States

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