NCT06592742Completed
Progressive Muscle Relaxation in Pulmonary Rehab for Quality of Life, Mental Health, and Sleep in Cystic Fibrosis
The Impact of Integrating Progressive Muscle Relaxation Into Pulmonary Rehabilitation on Quality of Life, Mental Health, and Physical Function in Adults With Cystic Fibrosis: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Dec 2024
Brief summary (registry, in English)
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-term disease that affects the lungs and can cause physical and mental health challenges, including anxiety, depression, and trouble sleeping. The study will involve two groups: one group will follow the usual PR program, which includes exercises to improve lung function and overall health, while the other group will also practice PMR, a technique to help relax muscles and reduce stress. The main goal is to see if adding PMR can improve participants quality of life, reduce anxiety and depression, and improve sleep quality. Investigators will use questionnaires to measure how participants feel about their mental and physical health and tests to assess their physical endurance, such as measuring how far they can walk in six minutes (6-Minute Walk Test). Investigators hope to find a better way to support people with CF in managing their physical and emotional health by combining physical therapy with relaxation techniques.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 5 Sept 2024
- Start date
- 13 Sept 2024
- Primary completion date
- 20 Dec 2024
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
- Diseases
- Cystic fibrosis
- NCT number
- NCT06592742
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 13 Sept 2024 to the primary completion date, 20 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have undergone a lung transplant or any other major surgery within the past 6 months
- Participants who have had significant changes in their medication regimen within the last 4 weeks
Other illness
- Participants who have experienced a pulmonary exacerbation or acute respiratory infection requiring hospitalization or intravenous (IV) antibiotics within the last 4 weeks
- Participants with severe comorbid conditions such as: uncontrolled cardiovascular disease, renal or liver failure, severe musculoskeletal disorders, severe or uncontrolled psychiatric disorders
- Participants with uncontrolled diabetes
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital of Infectious Disease and Pneumoftiziology Victor Babes Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.