Status:
COMPLETED
Progressive Muscle Relaxation in Pulmonary Rehab for Quality of Life, Mental Health, and Sleep in Cystic Fibrosis
Lead Sponsor:
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
Conditions:
Cystic Fibrosis (CF)
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study, called PRIME-CF, will look at how adding progressive muscle relaxation (PMR) to a typical pulmonary rehabilitation (PR) program might help adults with cystic fibrosis (CF). CF is a long-te...
Detailed Description
Our study aims to evaluate the effects of integrating progressive muscle relaxation (PMR) into a standard pulmonary rehabilitation (PR) program on quality of life, mental health, sleep quality, and ph...
Eligibility Criteria
Inclusion
- Confirmed cystic fibrosis diagnosis based on clinical, genetic, or sweat chloride testing, as defined by established CF diagnostic criteria.
- 18 years or older at the time of enrollment
- Participants must have stable lung function, defined as a Forced Expiratory Volume in 1 second (FEV1)
- Participants must not have had a pulmonary exacerbation requiring hospitalization or intravenous (IV) antibiotics within the past 4 weeks before the start of the study
- Physically able to engage in the daily exercise and airway clearance components of the pulmonary rehabilitation program
- Participants must be willing and able to participate in daily progressive muscle relaxation
- Participants must be on a stable medication regimen for at least 4 weeks before study enrollment
- Participants must be non-smokers or have quit smoking for at least 6 months before enrollment
- Participants must be able to understand and provide written informed consent, indicating their willingness to participate in the study, adhere to the intervention schedule, and comply with follow-up assessments
Exclusion
- Participants who have experienced a pulmonary exacerbation or acute respiratory infection requiring hospitalization or intravenous (IV) antibiotics within the last 4 weeks
- Participants who have undergone a lung transplant or any other major surgery within the past 6 months
- Participants with severe comorbid conditions such as: uncontrolled cardiovascular disease, renal or liver failure, severe musculoskeletal disorders, severe or uncontrolled psychiatric disorders
- Participants who have had significant changes in their medication regimen within the last 4 weeks
- Participants with uncontrolled diabetes
Key Trial Info
Start Date :
September 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06592742
Start Date
September 13 2024
End Date
December 20 2024
Last Update
December 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital of Infectious Disease and Pneumoftiziology Victor Babes
Timișoara, Romania, 300310