Progressive Muscle Relaxation in Pulmonary Rehab for Quality of Life, Mental Health, and Sleep in Cystic Fibrosis

Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara22 enrolled

Overview

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.

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.

Interventions

Pulmonary rehabilitation (alone)BEHAVIORAL

The Pulmonary Rehabilitation (PR) program for the control group includes daily aerobic exercises such as treadmill walking or cycling for 20-30 minutes at moderate intensity, tailored to improve cardiovascular fitness and respiratory function. Strength training focuses on major muscle groups with resistance exercises lasting 15-20 minutes, promoting muscle strength and endurance. Airway clearance techniques are performed for 15-20 minutes daily, using methods like chest physiotherapy or positive expiratory pressure (PEP) to clear mucus from the lungs. Breathing exercises, including diaphragmatic and pursed-lip breathing, are practiced for 10-15 minutes to improve breathing efficiency. Participants also receive education on disease management and nutritional support to meet caloric needs.

Intervention group (PR + PMR)BEHAVIORAL

The intervention group will follow a Pulmonary Rehabilitation (PR) program combined with Progressive Muscle Relaxation (PMR). Daily aerobic exercises like treadmill walking or cycling will be performed for 20-30 minutes at moderate intensity, improving cardiovascular fitness and lung function. Strength training for major muscle groups will be included, with 15-20 minutes of resistance exercises to enhance muscle strength. Airway clearance techniques, such as chest physiotherapy or PEP, will help clear mucus from the lungs in daily 15-20 minute sessions. Breathing exercises, including diaphragmatic and pursed-lip breathing, will be practiced for 10-15 minutes to improve breathing efficiency. The PMR component involves daily 20-30 minute guided sessions to reduce stress and anxiety through muscle relaxation techniques.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Outcomes

Primary Outcomes

Health related Quality of life

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.