Exercise Program for Cystic Fibrosis

Overseen By Heather Hathorne

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Comorbidity precluding exercise

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: 6

Duration: 12 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an exercise program can benefit people with cystic fibrosis (CF) who are currently stable but have experienced flare-ups in the past. Participants receive a personalized exercise plan and support via video calls, similar to telehealth appointments. The focus is on enhancing daily life and managing CF symptoms through regular, guided exercise. This trial suits individuals diagnosed with CF, aged 18 or older, who have been flare-up-free for at least six weeks. As an unphased trial, it offers a unique opportunity to contribute to understanding how exercise can improve life for those with CF.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this exercise program is safe for patients with cystic fibrosis?

Research shows that exercise is generally safe for people with cystic fibrosis (CF), with side effects being rare. Studies indicate that regular physical activity can enhance exercise capacity and provide benefits such as improved lung function. Overall, this evidence suggests that exercise is well-tolerated and safe for individuals with CF. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this exercise program for cystic fibrosis because it offers a new way to enhance patient care through a tailored and supervised exercise regimen. Unlike typical treatments that focus on medication and physical therapy, this program uses telehealth to deliver personalized exercise plans and behavior change techniques, making it accessible and convenient. Patients engage in three one-hour sessions per week over 12 weeks, potentially improving adherence and outcomes by fitting seamlessly into their daily lives. This approach could revolutionize how patients manage their condition by integrating fitness directly into their care routine.

What evidence suggests that this exercise program is effective for cystic fibrosis?

Research shows that exercise programs can benefit people with cystic fibrosis (CF). Studies have found that exercise strengthens muscles, enhances heart and lung fitness, and improves the function of breathing muscles. For instance, individuals with CF who exercised for more than six months experienced significant improvements in their exercise capacity. Another study found that exercise also enhances lung function and the body's ability to use oxygen. Overall, exercise appears to be a promising method for managing CF symptoms and improving health. Participants in this trial will receive a supervised exercise plan tailored to their needs, delivered through a video platform over a 12-week period. ^{1 4 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 have been stable without exacerbations for at least 6 weeks. It's not suitable for those with other health conditions that make exercise unsafe.

Inclusion Criteria

I am 18 or older with Cystic Fibrosis and have been stable for the last 6 weeks.

Exclusion Criteria

You have a health condition that makes it difficult for you to exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a tailored exercise regimen and behavior change techniques via video telehealth over 12 weeks

12 weeks

3 visits per week (virtual)

Follow-up

Participants have monthly phone follow-ups and clinic follow-ups at 3 and 6 months to monitor adherence and sustainability

6 months

Monthly phone follow-ups, clinic visits at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview

The study tests a video telehealth exercise program designed specifically for patients with Cystic Fibrosis to see if it can improve their health and manage symptoms.

How Is the Trial Designed?

Group I: supervised exercise plan Experimental Treatment 1 Intervention

patients will receive a tailored exercise regimen and behavior change techniques focused on adherence to the exercise program. These will be delivered by using a video platform, much liker telehealth clinic appointments. These telehealth visits will be over a 12-week period, occur 3 times a week, and last for 1 hour each.

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

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]

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]

Exercise training, particularly aerobic and resistance training, is beneficial for individuals with cystic fibrosis (CF), improving aerobic capacity and strength based on a systematic review of 12 studies.

While exercise training does not significantly improve pulmonary function, it may help preserve it, and more consistent measures of health-related quality of life (HRQL) are needed in future research to draw stronger conclusions about its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence regarding exercise training in the management of cystic fibrosis: a systematic review. Shoemaker, MJ., Hurt, H., Arndt, L.[2022]

A 3-month home exercise training program significantly improved exercise capacity and oxygen uptake in 10 adolescent cystic fibrosis patients, demonstrating its efficacy as a treatment option.

Patients were able to maintain the benefits of the training during a 1-month follow-up period, suggesting that home exercise can be a sustainable part of their ongoing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a home exercise training program in patients with cystic fibrosis. de Jong, W., Grevink, RG., Roorda, RJ., et al.[2019]

Regular exercise significantly slows the decline in lung function in people with cystic fibrosis (CF) by enhancing mucus clearance, supported by substantial evidence.

Exercise training over a period of 6 months improves aerobic capacity and has a positive overall effect on quality of life for individuals with CF, making it a recommended part of their management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exercise in maintaining health in cystic fibrosis. Dwyer, TJ., Elkins, MR., Bye, PT.[2011]

A 3-week intensive training program for 17 cystic fibrosis patients led to significant improvements in physical performance, including a 12% to 20% increase in maximal power and oxygen uptake during exercise tests.

Lung function also showed positive trends, with vital capacity and FEV1 increasing by 7% and 6%, respectively, suggesting that short-term, well-supported exercise can enhance both physical and respiratory health in CF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of an optimized exercise therapy on physical performance of patients with cystic fibrosis]. Rhodius, U., Posselt, S., Posselt, HG., et al.[2009]

Exercise interventions for children and adults with cystic fibrosis (CF) improve muscle strength and cardiovascular capacity, but do not significantly enhance lung function, as shown in a systematic review of randomized controlled trials.

High-intensity aerobic training and strength training programs are the most effective types of exercise for improving physical condition in adults with CF, although there have been limited studies on these specific interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Physical Exercise Interventions on Pulmonary Function and Physical Fitness in Children and Adults with Cystic Fibrosis: A Systematic Review with Meta-Analysis. García-Pérez-de-Sevilla, G., Yvert, T., Blanco, Á., et al.[2022]

A study involving 4208 cystic fibrosis patients found that exercise testing is safe, with no severe adverse reactions reported during 713 exercise tests.

The incidence of exercise-related severe adverse reactions, such as pneumothorax or cardiac arrhythmia, was less than 1% per year, and 67% of patients reported no adverse reactions from exercise, indicating a low risk associated with physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks associated with exercise testing and sports participation in cystic fibrosis. Ruf, K., Winkler, B., Hebestreit, A., et al.[2015]

Exercise programs, including both aerobic and strength training, can significantly improve pulmonary function and fitness in children with cystic fibrosis, as shown in a review of four randomized controlled trials.

Short-term aerobic and strength interventions were particularly effective, indicating that structured exercise could be a beneficial component of treatment for children with varying severity of cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise programs for children with cystic fibrosis: a systematic review of randomized controlled trials. van Doorn, N.[2022]

A review of 15 studies involving 463 participants found that exercise interventions can effectively promote physical activity in individuals with Cystic Fibrosis, with 11 studies showing positive results.

Aerobic training and activity counseling were the most effective strategies identified for improving physical activity levels, although there was significant variability in the types of interventions and assessment tools used across the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise interventions to increase physical activity in Cystic Fibrosis: A systematic review. Curran, M., Tierney, AC., Button, B., et al.[2022]

Children with cystic fibrosis (CF) demonstrated satisfactory levels of physical activity (PA), with 68% being active, which positively correlated with their quality of life (QoL) scores, particularly in emotional health.

Despite the positive correlation between PA and QoL, the study found no significant relationship between PA levels and lung function (measured by FEV1%), indicating that while PA benefits QoL, it may not directly impact lung function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Quality of Life among Patients with Cystic Fibrosis. Giannakoulakos, S., Gioulvanidou, M., Kouidi, E., et al.[2022]

A two-month, subject-designed exercise program for individuals with cystic fibrosis led to significant improvements in exercise capacity and body image perception, indicating enhanced quality of life (QoL).

Participants who improved their exercise capacity also experienced notable increases in lung function and self-reported habitual activity, suggesting that regular physical activity can positively impact lung health in cystic fibrosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise improves lung function and habitual activity in children with cystic fibrosis. Paranjape, SM., Barnes, LA., Carson, KA., et al.[2012]

Exercise training in children with cystic fibrosis does not negatively impact nutritional status and can lead to positive changes, such as increased fat-free mass and improved aerobic capacity.

Resistance exercise specifically has been shown to enhance body mass in children with cystic fibrosis, indicating that exercise can be beneficial for their overall health without compromising nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise on Nutritional Status in People with Cystic Fibrosis: A Systematic Review. Nicolson, WB., Bailey, J., Alotaibi, NZ., et al.[2023]

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Fitness

Research shows that regular physical activity or exercise provides multiple benefits for people with cystic fibrosis. These benefits go beyond better lung ...