~2 spots leftby Dec 2025

Behavioral Counseling + Exercise for Cystic Fibrosis

Recruiting in Palo Alto (17 mi)
SK
Overseen byStefanie Krick, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Exercising >60 min/week, Hemoptysis, Pneumothorax, others
No Placebo Group
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on adding exercise and behavioral counseling to your treatment, so you may not need to stop your medications.

What data supports the idea that Behavioral Counseling + Exercise for Cystic Fibrosis is an effective treatment?

The available research shows that regular exercise and physical activity are important for people with cystic fibrosis. Studies have found that increased physical activity can slow the decline in lung function and improve quality of life. Although there is limited research specifically on behavioral counseling interventions, exercise is recommended as part of the treatment plan for cystic fibrosis. This suggests that combining exercise with behavioral counseling could be beneficial, even though more research is needed to confirm its effectiveness compared to other treatments.12345

What safety data exists for behavioral counseling and exercise in cystic fibrosis treatment?

The available research indicates that exercise is a recommended component of cystic fibrosis treatment, with potential benefits for physical fitness, quality of life, and respiratory function. However, there is limited specific safety data on behavioral counseling combined with exercise. Current studies suggest exercise is beneficial, but larger trials are needed to better understand its role and safety in cystic fibrosis management.12467

Is Behavioral Counseling and Exercise a promising treatment for Cystic Fibrosis?

Yes, Behavioral Counseling and Exercise is a promising treatment for Cystic Fibrosis. It is recommended as part of the treatment plan because it can improve physical function and quality of life. Many centers recognize its benefits, and it is seen as important for managing the condition.12589

Research Team

SK

Stefanie Krick, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 with Cystic Fibrosis who are currently hospitalized for a pulmonary exacerbation and will stay in the hospital for at least 10 days. They must have internet access, be willing to start an exercise program, and not already exercising more than 60 minutes per week. Those with recent severe lung complications or physical impairments that prevent exercise cannot join.

Inclusion Criteria

I am going to be hospitalized for a lung problem for at least 10 days.
You are willing to commit to a regular exercise program throughout the study.
You need to have high-speed internet to participate in the study.
See 2 more

Exclusion Criteria

You are currently exercising for more than 1 hour per week.
You have a physical condition that prevents you from exercising.
I have not had severe coughing up of blood or lung collapse in the last 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Hospitalization and Exercise Program

Participants perform supervised exercise 6 days a week during hospitalization, including aerobic and resistance training, along with behavioral counseling.

2-3 weeks
Daily supervised sessions

Outpatient Follow-up

Routine care following hospitalization includes an outpatient CF clinic visit 2-4 weeks after discharge.

2-4 weeks
1 visit (in-person)

Long-term Follow-up

Participants are monitored for pulmonary function and adherence to exercise regimen.

1 year

Treatment Details

Interventions

  • Behavioral Counseling and Exercise (Behavioural Intervention)
Trial OverviewThe study tests a new approach combining exercise with behavioral counseling during hospitalization for Cystic Fibrosis patients. The goal is to see if starting this regimen when patients are acutely aware of their health can improve long-term adherence to regular physical activity.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: behavioral intervention to improve physical activityExperimental Treatment1 Intervention
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+
Kierstin Kennedy profile image

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella profile image

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

In a study involving 88 individuals with cystic fibrosis (ages 6 to 50) participating in a 12-month exercise program, physical barriers to exercise were found to be more significant than psychosocial barriers, indicating that addressing these physical challenges is crucial for increasing physical activity.
The study revealed that supervision during the exercise program did not significantly improve the management of barriers to physical activity, suggesting that ongoing sport counseling and personalized strategies are essential for encouraging regular exercise in individuals with cystic fibrosis.
Barriers for Sports and Exercise Participation and Corresponding Barrier Management in Cystic Fibrosis.Dillenhoefer, S., Stehling, F., Welsner, M., et al.[2023]
A national survey of 62 specialized cystic fibrosis centers revealed that while 60% perform exercise testing, the protocols are often unstandardized, indicating a need for more consistent practices in assessing patients' fitness.
Despite the underutilization of standardized exercise programs, 87% of caregivers recognize the importance of physical exercise for cystic fibrosis patients, suggesting a strong interest in improving exercise-related care.
Exercise testing and training in German CF centers.Barker, M., Hebestreit, A., Gruber, W., et al.[2015]

References

Physical Activity Counseling for Children With Cystic Fibrosis. [2018]
Current perspectives of physical activity in cystic fibrosis. [2020]
Exercise and physical activity in children with cystic fibrosis. [2009]
[Physical activity and exercise training for patients with cystic fibrosis]. [2018]
Use of exercise in the management of cystic fibrosis: short communication about a survey of cystic fibrosis referral centers. [2019]
Barriers for Sports and Exercise Participation and Corresponding Barrier Management in Cystic Fibrosis. [2023]
Exercise as a therapeutic intervention for people with cystic fibrosis. [2022]
Exercise testing and training in German CF centers. [2015]
Development and validation of the Cystic Fibrosis Decisional Balance for Physical Activity scale (CF-DB-PA). [2021]