Progressive Muscle Relaxation in Pulmonary Rehab for Quality of Life, Mental Health, and Sleep in Cystic Fibrosis
- Conditions
- Cystic Fibrosis (CF)
- Registration Number
- NCT06592742
- Lead Sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
- 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-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.
- 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 physical endurance in adults with cystic fibrosis (CF). CF is a chronic genetic disorder that imposes a heavy physical and psychological burden on patients, often resulting in anxiety, depression, and sleep disturbances. While PR effectively improves lung function and physical capacity, its impact on mental health and sleep quality is less established. PMR, a relaxation technique that reduces stress and improves mental well-being, is integrated into this study's PR program to assess whether it can further enhance outcomes in CF patients.
The study will include adults with CF randomly assigned to either a control group (standard PR program) or an intervention group (PR program plus PMR). The PR program will involve daily exercise sessions, including aerobic and strength training, airway clearance techniques, and medical education. The intervention group will also participate in daily guided PMR sessions designed to reduce muscle tension and psychological stress.
The studys primary outcomes will be changes in quality of life, assessed using the Cystic Fibrosis Questionnaire-Revised (CFQ-R), and mental health, measured by the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes include improvements in sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI), and physical endurance, assessed via the 6-Minute Walk Test (6MWT). Data will be collected at baseline, post-intervention, and at a 4-week follow-up to evaluate the sustainability of any benefits.
The study is designed to determine whether adding PMR to a PR program can meaningfully improve CF management in both the physical and mental health domains, offering a more comprehensive approach to the care of adult CF patients. The findings are expected to contribute to developing more holistic treatment protocols for CF, integrating mental health interventions into traditional pulmonary rehabilitation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Health related Quality of life At inclusion, at 21 days, at 48 days. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific tool designed to assess the health-related quality of life in individuals with cystic fibrosis (CF). It includes 47 items that cover several domains: physical functioning, emotional well-being, vitality, social functioning, body image, eating problems, treatment burden, respiratory symptoms, and digestive symptoms. Scores range from 0 to 100, with higher scores indicating better quality of life. The CFQ-R is used in clinical trials, research, and routine care to measure the impact of CF on daily life and the effectiveness of interventions.
Mental Health At inclusion, at 21 days, at 48 days. The Hospital Anxiety and Depression Scale (HADS) is a widely used tool to assess symptoms of anxiety and depression in patients with physical health conditions. It consists of 14 items, divided into two subscales: 7 for anxiety (HADS-A) and 7 for depression (HADS-D). Each item is scored on a scale from 0 to 3, with total scores ranging from 0 to 21 for each subscale. Higher scores indicate greater levels of anxiety or depression. Scores are categorized as normal (0-7), mild (8-10), moderate (11-14), or severe (15-21).
- Secondary Outcome Measures
Name Time Method Sleep Quality At inclusion, at 21 days, at 48 days. The Pittsburgh Sleep Quality Index (PSQI) is a widely used tool designed to assess sleep quality and identify sleep disturbances over a 1-month period. It consists of 19 self-rated items that are grouped into seven components: sleep duration, sleep latency, sleep efficiency, sleep disturbances, use of sleep medication, daytime dysfunction, and subjective sleep quality. Each component is scored from 0 to 3, with a total score ranging from 0 to 21; higher scores indicate worse sleep quality. A total score above 5 suggests poor sleep quality.
Physical Endurance At inclusion, at 21 days, at 48 days. The 6-Minute Walk Test (6MWT) is a simple, practical test used to assess functional exercise capacity in patients with chronic conditions, including cystic fibrosis. During the test, a patient walks for 6 minutes on a flat, straight course, aiming to cover as much distance as possible at their own pace, while taking breaks if necessary. The total distance walked, measured in meters, is the main outcome, with a longer distance indicating better exercise capacity.
Lung Function At inclusion, at 21 days, at 48 days. Lung function will assess the impact of the intervention (PR + PMR) on participants respiratory health. The primary tool used for this evaluation will be spirometry. This standard pulmonary function test measures how well the lungs work by assessing the volume and flow of air during breathing. Forced Expiratory Volume in 1 Second (FEV1) will be recorded. It reflects airway obstruction, with improvements indicating better lung function. FEV1 is reported as a percentage of the predicted value based on age, sex, and height.
Trial Locations
- Locations (1)
Hospital of Infectious Disease and Pneumoftiziology Victor Babes
🇷🇴Timisoara, Romania
Hospital of Infectious Disease and Pneumoftiziology Victor Babes🇷🇴Timisoara, Romania