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OpenTrials
Completed

NCT Number: NCT04543929

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

partially supervised and home-based exercise activity

Primary outcomes

  1. Aerobic Exercise Capacity - V02max

    Time frame: 18 months

    anaerobic threshold (V02max) measured via Sub-maximal cardiopulmonary exercise test (CPET)

Secondary outcomes

  1. Pulmonary function testing

    Time frame: 18 months

    Standardized testing to measure forced expiratory volume 1 sec (FEV1)

  2. Quality of Life measured by Cystic Fibrosis Questionnaire - Revised (CFQ-R)

    Time frame: 18 months

    cystic fibrosis questionnaire (CFQ-R) score. Standardized scores ranging from 0 to 100; higher scores indicated better health related quality of life

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2020
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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