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Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

exercise

no exercise

Arm Description

exercise prescription + standard of care

no exercise prescription + standard of care

Outcomes

Primary Outcome Measures

Aerobic Exercise Capacity
anaerobic threshold via Sub-maximal cardiopulmonary exercise test

Secondary Outcome Measures

pulmonary function
forced expiratory volume in 1 second (FEV1)
Quality of Life measured by CFQ-R
cystic fibrosis questionnaire (CFQ-R) score
Impact on sweat chloride
Sweat Chloride Testing
diabetes risk
Point-of-Care HbA1c

Full Information

First Posted
September 2, 2020
Last Updated
September 2, 2020
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04543929
Brief Title
Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis
Official Title
Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise
Arm Type
Active Comparator
Arm Description
exercise prescription + standard of care
Arm Title
no exercise
Arm Type
No Intervention
Arm Description
no exercise prescription + standard of care
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
partially supervised and home-based exercise activity
Primary Outcome Measure Information:
Title
Aerobic Exercise Capacity
Description
anaerobic threshold via Sub-maximal cardiopulmonary exercise test
Time Frame
3 months
Secondary Outcome Measure Information:
Title
pulmonary function
Description
forced expiratory volume in 1 second (FEV1)
Time Frame
3 months
Title
Quality of Life measured by CFQ-R
Description
cystic fibrosis questionnaire (CFQ-R) score
Time Frame
3 months
Title
Impact on sweat chloride
Description
Sweat Chloride Testing
Time Frame
3 months
Title
diabetes risk
Description
Point-of-Care HbA1c
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine D Morgan, BA
Phone
913-588-1572
Email
cmorgan6@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Larry Scott
Phone
913-588-1572
Email
lscott2@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Burnett, Ph.D.
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Morgan
Phone
913-588-1572
Email
cmorgan6@kumc.edu
First Name & Middle Initial & Last Name & Degree
Larry Scott
Phone
913-588-1572
Email
lscott2@kumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

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