- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04543929
Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis
September 2, 2020 updated by: Dave Burnett, University of Kansas Medical Center
This study will be a randomized controlled trial in patients with cystic fibrosis and conducted over a consecutive twelve-week period.
A comparison standard of care group will be used as a control to an interventional exercise group.
The study evaluates the effectiveness of standard of care therapy + exercise compared to standard of care only for improving cardiorespiratory-fitness in CF patients.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christine D Morgan, BA
- Phone Number: 913-588-1572
- Email: cmorgan6@kumc.edu
Study Contact Backup
- Name: Larry Scott
- Phone Number: 913-588-1572
- Email: lscott2@kumc.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center
-
Contact:
- Larry Scott
- Phone Number: 913-588-1572
- Email: lscott2@kumc.edu
-
Contact:
- Christine Morgan
- Phone Number: 913-588-1572
- Email: cmorgan6@kumc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosed with Cystic Fibrosis
- Prescribed and taking for 28 days ivacaftor-tezacaftor-elexacaftor (Trikafta)
- 18 years and older
Exclusion Criteria:
- 17 years of age or less
- not eligible for ivacaftor-tezacaftor-elexacaftor (Trikafta)
- inability to exercise
- pregnancy
- status post lung transplantation
- already participating in more than 150 minutes of aerobic exercise per week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: exercise
exercise prescription + standard of care
|
partially supervised and home-based exercise activity
|
No Intervention: no exercise
no exercise prescription + standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic Exercise Capacity
Time Frame: 3 months
|
anaerobic threshold via Sub-maximal cardiopulmonary exercise test
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pulmonary function
Time Frame: 3 months
|
forced expiratory volume in 1 second (FEV1)
|
3 months
|
Quality of Life measured by CFQ-R
Time Frame: 3 months
|
cystic fibrosis questionnaire (CFQ-R) score
|
3 months
|
Impact on sweat chloride
Time Frame: 3 months
|
Sweat Chloride Testing
|
3 months
|
diabetes risk
Time Frame: 3 months
|
Point-of-Care HbA1c
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dave Burnett, Ph.D., University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2020
Primary Completion (Anticipated)
September 30, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
September 2, 2020
First Submitted That Met QC Criteria
September 2, 2020
First Posted (Actual)
September 10, 2020
Study Record Updates
Last Update Posted (Actual)
September 10, 2020
Last Update Submitted That Met QC Criteria
September 2, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00143513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystic Fibrosis
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Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
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University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Royal College of Surgeons, IrelandThe Hospital for Sick Children; Imperial College London; Erasmus Medical Center; University College Dublin and other collaboratorsActive, not recruitingCystic Fibrosis | Adherence, Medication | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in Children | Cystic Fibrosis Liver DiseaseUnited Kingdom, Ireland
-
Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
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The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
-
University Hospital, BordeauxCompleted
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