Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: exercise

• Registration Number: NCT04543929
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-02-11
• Primary Completion: 2020-06-23
• Study Completion: 2020-06-23
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise	exercise	exercise prescription + standard of care

Primary Outcome Measures

Name	Time	Method
Aerobic Exercise Capacity - V02max	18 months	anaerobic threshold (V02max) measured via Sub-maximal cardiopulmonary exercise test (CPET)

Secondary Outcome Measures

Name	Time	Method
Pulmonary function testing	18 months	Standardized testing to measure forced expiratory volume 1 sec (FEV1)
Quality of Life measured by Cystic Fibrosis Questionnaire - Revised (CFQ-R)	18 months	cystic fibrosis questionnaire (CFQ-R) score. Standardized scores ranging from 0 to 100; higher scores indicated better health related quality of life

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States