Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: exercise

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: exercise; exercise prescription + standard of care	Behavioral: exercise; partially supervised and home-based exercise activity
No Intervention: no exercise; no exercise prescription + standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic Exercise Capacity - V02max	anaerobic threshold (V02max) measured via Sub-maximal cardiopulmonary exercise test (CPET)	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function testing	Standardized testing to measure forced expiratory volume 1 sec (FEV1)	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	18 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Dave Burnett, Ph.D., University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Actual): June 23, 2020
• Study Completion (Actual): June 23, 2020

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: STUDY00143513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No