Behavioral Counseling + Exercise for Cystic Fibrosis

Overseen By Heather Hathorne, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Exercising >60 min/week, Hemoptysis, Pneumothorax, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people with cystic fibrosis stay active. Researchers aim to determine if starting an exercise program combined with behavioral counseling during a hospital stay can make it easier for patients to continue exercising after discharge. The goal is to improve the long-term health of those hospitalized due to cystic fibrosis flare-ups (worsening of symptoms). Individuals with cystic fibrosis who are currently hospitalized for a flare-up and wish to start exercising regularly might be a good fit. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative strategies that could enhance their quality of life.

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 prior data suggests that this protocol is safe for patients with cystic fibrosis?

Research shows that physical activity, such as exercise, is generally safe for people with cystic fibrosis (CF), with side effects being rare. Studies suggest that exercise can improve lung function and overall fitness.

However, specific safety information on combining behavioral counseling with exercise for CF patients is limited. Despite this, existing research indicates that exercise benefits people with CF and is considered a safe choice. The goal is to help patients maintain their exercise routines over time, potentially leading to better health.

In summary, while data on combining exercise with behavioral counseling is limited, exercise alone is known to be safe and beneficial for those with CF. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of behavioral counseling and exercise for managing cystic fibrosis because it adds a new dimension to care beyond the usual medications and airway clearance techniques. This approach focuses on empowering patients with tailored exercise plans and behavioral strategies to maintain long-term physical activity, which could enhance overall health and quality of life. Unlike traditional treatments that primarily address symptoms and exacerbations, this method aims to instill sustainable lifestyle changes, potentially reducing hospitalizations and improving respiratory function over time.

What evidence suggests that this protocol is effective for cystic fibrosis?

Research has shown that combining behavioral counseling with exercise can benefit people with cystic fibrosis. In this trial, participants will receive a tailored exercise prescription along with daily behavioral counseling. Studies indicate that exercise programs can strengthen muscles, improve heart and lung function, and aid breathing. Exercise routines lasting six months or more are likely to enhance fitness levels compared to inactivity. Participants in these programs have demonstrated increased physical activity and improved quality of life. High-intensity exercise, in particular, effectively boosts endurance and is well-tolerated by adults with cystic fibrosis. ^{1 2 5 6 7}

Who Is on the Research Team?

Stefanie Krick, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Counseling and Exercise

Trial Overview

The 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.

How Is the Trial Designed?

Group I: behavioral intervention to improve physical activity Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Regular exercise is recommended for individuals with cystic fibrosis (CF) to improve physical function and health outcomes, but the optimal training methods remain unclear.

Current evidence suggests that people with CF should engage in concerted exercise bouts of at least 10 minutes, alongside their daily activities, to maximize health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current perspectives of physical activity in cystic fibrosis. Cox, NS., Holland, AE.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers for Sports and Exercise Participation and Corresponding Barrier Management in Cystic Fibrosis. Dillenhoefer, S., Stehling, F., Welsner, M., et al.[2023]

Patients with cystic fibrosis in France currently receive multidisciplinary care, but there is a lack of focus on promoting physical activity despite its known therapeutic benefits.

The article proposes a comprehensive approach to integrate physical activity into cystic fibrosis management, including quantifying exercise, evaluating training programs, and modifying patient behavior, with plans for multicenter studies to assess the impact of these recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise training for patients with cystic fibrosis]. Karila, C., Ravilly, S., Gauthier, R., et al.[2018]

A survey of 47 cystic fibrosis referral centers revealed that while nearly all centers recommend exercise for cystic fibrosis patients, only a small percentage (21.7%) actually provide structured exercise programs.

Aerobic exercise, particularly swimming, is the most commonly prescribed type of exercise, indicating a recognition of its benefits, but there remains a significant gap between the acknowledgment of exercise's importance and the availability of exercise services for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of exercise in the management of cystic fibrosis: short communication about a survey of cystic fibrosis referral centers. Kaplan, TA., ZeBranek, JD., McKey, RM.[2019]

A feasibility study involving 13 children and youth with cystic fibrosis showed that a parent-mediated counseling intervention to increase physical activity was both acceptable and effective, with no adverse events reported.

Participants demonstrated positive trends in physical activity levels and quality of life improvements after the intervention, indicating that counseling could be a valuable addition to cystic fibrosis treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Counseling for Children With Cystic Fibrosis. Moola, FJ., Garcia, E., Huynh, E., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing and training in German CF centers. Barker, M., Hebestreit, A., Gruber, W., et al.[2015]

The Cystic Fibrosis Decisional Balance for Physical Activity (CF-DB-PA) scale was validated with 201 French adults with cystic fibrosis, demonstrating good reliability and validity for assessing factors that influence physical activity behaviors.

The scale identifies facilitators and barriers to physical activity, showing that facilitators positively correlate with self-reported physical activity and quality of life, while barriers negatively correlate with these outcomes, highlighting the importance of addressing these factors to improve physical activity in individuals with cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of the Cystic Fibrosis Decisional Balance for Physical Activity scale (CF-DB-PA). Filleul, V., Ladune, R., Gruet, M., et al.[2021]

Regular exercise and physical activity are crucial for patients with cystic fibrosis (CF), as they can slow the decline in lung function and improve overall health and quality of life.

Healthcare providers need to be educated on the importance of incorporating exercise into the routine care of CF patients to help them overcome barriers to participation and enhance long-term adherence to physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and physical activity in children with cystic fibrosis. Wilkes, DL., Schneiderman, JE., Nguyen, T., et al.[2009]

Exercise is recommended for individuals with cystic fibrosis (CF) as it may improve physical fitness and health-related quality of life, and could potentially slow the decline in respiratory function.

Current studies on exercise in CF have limitations, such as small sample sizes and insufficient duration, highlighting the need for larger, multi-centred trials to better understand its benefits and role in CF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as a therapeutic intervention for people with cystic fibrosis. Ward, N., Stiller, K., Holland, AE.[2022]

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