Cystic FibrosisNCT02715921
Impact of Telerehabilitation Training on Pediatric Cystic Fibrosis Patients: An Exploratory Study
A study testing Tele-exercise in people with Cystic Fibrosis, run by MemorialCare Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tele-exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 7 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Exercise and Genomics Research Center
Irvine, California, 92697
About this 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.
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Tele-exercise
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis patients | Experimental | Receive tele-exercise training and undergo pulmonary function testing and exercise testing Receives: Other: Tele-exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (3)
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.
Measured: 30 minutes
Cystic fibrosis quality of life survey
Approximately 50 questions related to quality of life in Cystic fibrosis.
Measured: 50 minutes
System usability survey
A ten question survey related to system usability. Answers for these questions range from 0 (strongly disagree) to 4 (strongly agree)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study start1 Jan 2015
- Primary completion25 Apr 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Jen Jen Chen, MD, Principal investigator, MemorialCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715921
- Sponsor's protocol ID
- 277-13
- Status last verified
- Jul 2026
- First submitted
- 12 Jan 2016
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telerehabilitation Training on Pediatric Cystic Fibrosis Patients: An Exploratory Study
- ClinicalTrials.gov ID
- NCT02715921
- Acronym / sponsor ID
- 277-13
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis patients | Experimental | Other: Tele-exerciseReceive tele-exercise training and undergo pulmonary function testing and exercise testing |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-exercise | Other | Cystic fibrosis patients |
Primary outcome
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.
3 secondary outcomes
Peak oxygen consumption
Time frame: 30 minutes
Cystic fibrosis quality of life survey
Time frame: 50 minutes
System usability survey
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen Jen Chen, MD principal investigator
MemorialCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-exercise in people with Cystic Fibrosis, run by MemorialCare Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Habitual activity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.