An interventional study of exercise in Cystic Fibrosis, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
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.
This study is a randomized control trial that compares MCT to HIIT using a patient-centered and home-based delivery model with CF Care Centers in the United States. Participants will be randomly allocated to either an MCT or HIIT arm. Both the MCT and HIIT interventions are accepted forms of prescribed exercise in clinical practice. The interventions will be delivered with a telehealth platform using internet (HIPAA-Compliant video), phone, and email/text support. All study sites will receive initial and on-going training and program facilitation to assure consistency of delivering the intervention. All participants across both arms visit their respective CF clinics on a regular basis for routine CF care. Thus, our research team will be able to coordinate all testing/assessment visits, including long-term (18-month timepoint), with participants throughout the study. The primary and secondary outcomes include important patient-centered outcomes as selected by our study's CF Patient and Stakeholder Advisory Board.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 9 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University of Kansas Medical Center is the lead sponsor of 484 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
exercise prescription + standard of care
Behavioral: exercise
no exercise prescription + standard of care
partially supervised and home-based exercise activity
Aerobic Exercise Capacity - V02max
anaerobic threshold (V02max) measured via Sub-maximal cardiopulmonary exercise test (CPET)
Time frame: 18 months
Pulmonary function testing
Standardized testing to measure forced expiratory volume 1 sec (FEV1)
Time frame: 18 months
Quality of Life measured by Cystic Fibrosis Questionnaire - Revised (CFQ-R)
cystic fibrosis questionnaire (CFQ-R) score. Standardized scores ranging from 0 to 100; higher scores indicated better health related quality of life
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center