Feasibility of a New Model for Exercise Prescription in Cystic Fibrosis

December 18, 2025 updated by: Stefanie Krick MD, University of Alabama at Birmingham

Feasibility of a New Model for Exercise Prescription Combined With Behavior Modification in Cystic Fibrosis

The purpose of this protocol is to begin an exercise program combined with behavioral counseling for patients who are hospitalized with a cystic fibrosis exacerbation. The exercise program will begin during the hospital stay. Beginning an exercise program during this period of reduced mobility and isolation may be an ideal time to deliver a structured exercise prescription along with a behavioral program to promote long-term adherence to exercise (structured physical activity) . Hospitalized patients have an acute awareness that their lung function is declining and may be more motivated and open to changing their behavior and adding exercise to their treatment regimen.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During the hospitalization (T0 to T1; Figure 1, next page), participants will perform supervised exercise 6 days/wk. On each of these days, there will be a 5-10 min warm up consisting of low intensity execises for lower and upper exermity muscles. The total time per week will be between 2.5 and 3.5 hours.

Three days/wk will consist of aerobic exercise ("frequency"). The various "modes (types)" for this exercise include 1) overground ambulation (including stairs), 2) treadmill ambulation, 3) stationary cycling, or 4) repetitive body-weight exercises (e.g., "jumping jacks"). The "time (duration)" of these sessions will be 20-30 min/day. The "intensity" will be moderate (40-60% of heart rate reserve and/or perceived dyspnea/exertion of 3-5) to vigogous (60-85% of heart rate reserve and/or perceived dyspnea/exertion of 6-8). Participants will be given a HR monitor and specific "target" HR ranges based on their resting HR in standing and their age predicted maximal HR (NOTE: maximal exercise testing will not be performed); they will also be familiarized and instructed in use of the Borg CR10 scale to rate perceived dyspnea/exertion Participants should be able to "talk comfortably" during moderate intensity exercise, while talking should be "somewhat challenging" during vigorous efforts; HR, as well as perceived exertion/dyspnea and "talk test" will be monitored throughout each supervised session by trained personnel.

On alternate days, participants will perform supervised resistance exercise training (3 days/wk; "frequency"). The various "modes (types)" for this exercise include 1) body-weight exercises (e.g., lunges, squats, jumping, situps, pushups) and/or 2) resistance bands and dumbbells; exercises will target upper extremity, trunk/core, and lower extremity muscles (NOTE: specific inspiratory muscle training will not be performed). The "intensity" of these exercises will be at approximately 12-15 repetition max (that is, on the 3rd set of an exercise, the participant should have difficulty performing more than 12-15 quality (good form) repetitions of the exercise. An appropriate number of exercises will be selected such that the exercise "duration (time)" will be 20-30 min/day.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed diagnosis of CF
  2. 18 years old or older
  3. Current pulmonary exacerbation with planned UAB hospitalization for at least 10 days
  4. Willing to participate in a regular, ongoing exercise program
  5. Access to broadband internet

Exclusion Criteria:

  1. Currently exercising more than 60 min/week
  2. Massive hemoptysis or pneumothorax in past 3 months
  3. Neuromusculoskeletal impairments that preclude exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: behavioral intervention to improve physical activity

The proposed study is prospective single-arm feasibility clinical trial that will enroll 12 hospitalized patients with CF in accordance with consensus criteria.

Standard care for an acute CF exacerbation includes i.v. antibiotics and airway clearance therapies for 10-14 days. Routine care following hospitalization is an outpatient CF clinic visit 2-4 weeks after discharge, and then regular follow up every 2-3 months.

In addition, to standard care in the hospital, study participants will receive a 1) tailored exercise prescription, 2) daily, individual, supervised, aerobic and strength/power training, as well as 3) daily behavioral counseling focused on topics related to long-term adherence to exercise (details below).
Behavioral: Behavioral Counseling and Exercise
exercise program combined with behavioral counseling for patients who are hospitalized with a cystic fibrosis exacerbation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pulmonary function
Time Frame: 1 year
forced expiratory volume in 1 second
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefanie Krick, MD, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300003983
  • UAB (Other Identifier: UAB)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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