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

Status

Unknown

Conditions

Intervention / Treatment

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

Study Contact Backup

Study Locations

    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Contact:

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

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.

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