Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis
1 other identifier
interventional
9
1 country
1
Brief Summary
The main objective of this study is to compare the effectiveness of two different exercise interventions in a patient-centered, home-based exercise program for improving cardiorespiratory-fitness in people with cystic fibrosis (CF). We hypothesize cystic fibrosis patients participating in a high intensity interval training (HIIT) group will experience greater improvements in cardiorespiratory-fitness than those in a moderate continuous training (MCT) group. Further, we plan to investigate the efficacy of the comparators on patient-centered outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2020
CompletedFirst Submitted
Initial submission to the registry
September 2, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedOctober 10, 2024
August 1, 2024
4 months
September 2, 2020
October 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Aerobic Exercise Capacity - V02max
anaerobic threshold (V02max) measured via Sub-maximal cardiopulmonary exercise test (CPET)
18 months
Secondary Outcomes (2)
Pulmonary function testing
18 months
Quality of Life measured by Cystic Fibrosis Questionnaire - Revised (CFQ-R)
18 months
Study Arms (2)
exercise
ACTIVE COMPARATORexercise prescription + standard of care
no exercise
NO INTERVENTIONno exercise prescription + standard of care
Interventions
Eligibility Criteria
You may qualify if:
- diagnosed with Cystic Fibrosis
- Prescribed and taking for 28 days ivacaftor-tezacaftor-elexacaftor (Trikafta)
- years and older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dave Burnett, Ph.D.
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D., Chair Dept. of Respiratory Care and Diagnostic Science
Study Record Dates
First Submitted
September 2, 2020
First Posted
September 10, 2020
Study Start
February 11, 2020
Primary Completion
June 23, 2020
Study Completion
June 23, 2020
Last Updated
October 10, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share