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NCT04543929 Clinical Trial

Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:
Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04543929
Other study ID # STUDY00143513
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 11, 2020
Est. completion date December 31, 2020

Study information
Verified date January 2020
Source University of Kansas Medical Center
Contact Christine D Morgan, BA
Phone 913-588-1572
Email cmorgan6@kumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 9
Est. completion date December 31, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• exercise
partially supervised and home-based exercise activity

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)
Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Aerobic Exercise Capacity anaerobic threshold via Sub-maximal cardiopulmonary exercise test 3 months
Secondary pulmonary function forced expiratory volume in 1 second (FEV1) 3 months
Secondary Quality of Life measured by CFQ-R cystic fibrosis questionnaire (CFQ-R) score 3 months
Secondary Impact on sweat chloride Sweat Chloride Testing 3 months
Secondary diabetes risk Point-of-Care HbA1c 3 months
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