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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Health related Quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group (PR alone)
The control group in this study will undergo a standard pulmonary rehabilitation (PR) program designed to improve lung function, physical endurance, and overall quality of life in patients with cystic fibrosis (CF). The intervention will last for 21 days, with participants attending daily sessions of structured PR. This group will not receive the progressive muscle relaxation (PMR) component.
干预措施: Pulmonary rehabilitation (alone) (Behavioral)
Intervention group (PR + PMR)
The intervention group in this study will participate in the standard pulmonary rehabilitation (PR) program, similar to the control group, but with progressive muscle relaxation (PMR) sessions aimed at improving mental health, reducing anxiety, and enhancing sleep quality. This group will receive both physical and mental health interventions over the 21-day program to assess the combined impact of PR and PMR on quality of life, mental health, sleep quality, and physical endurance.
干预措施: Intervention group (PR + PMR) (Behavioral)
结局指标
主要结局
Health related Quality of life
时间窗: 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
时间窗: 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).
次要结局
- Sleep Quality(At inclusion, at 21 days, at 48 days.)
- Physical Endurance(At inclusion, at 21 days, at 48 days.)
- Lung Function(At inclusion, at 21 days, at 48 days.)
研究者
Crisan Alexandru Florian
Principal Investigator
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara