Feasibility of a New Model for Exercise Prescription in Cystic Fibrosis

NCT04075864 | Completed

• 2 other identifiers: IRB-300003983UAB
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• pulmonary function

  forced expiratory volume in 1 second

  1 year

Study Arms (1)

behavioral intervention to improve physical activity

EXPERIMENTAL

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

Interventions

Behavioral Counseling and Exercise BEHAVIORAL

exercise program combined with behavioral counseling for patients who are hospitalized with a cystic fibrosis exacerbation

behavioral intervention to improve physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Behavior Therapy; Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stefanie Krick, MD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: December 1, 2020
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)