Clinical trial NCT06592742: Progressive Muscle Relaxation in Pulmonary Rehab for Quality of Life, Mental Health, and Sleep in Cystic Fibrosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis (CF)
Keywords: cystic fibrosis
mental health
sleep quality
anxiety and depression
progressive muscle relaxation
Lead sponsor: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In our study participants are randomly assigned to one of two groups:

Intervention Group: receives the pulmonary rehabilitation program with PMR. Control Group: receives the standard PR program only, without PMR.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health related Quality of life
timeFrame: At inclusion, at 21 days, at 48 days.
measure: Mental Health
timeFrame: At inclusion, at 21 days, at 48 days.
Secondary outcomes:
measure: Sleep Quality
timeFrame: At inclusion, at 21 days, at 48 days.
measure: Physical Endurance
timeFrame: At inclusion, at 21 days, at 48 days.
measure: Lung Function
timeFrame: At inclusion, at 21 days, at 48 days.
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Hospital of Infectious Disease and Pneumoftiziology Victor Babes
Study officials:
affiliation: University of Medicine and Pharmacy "Victor Babes" Timisoara
name: Alexandru Crisan, Phd
role: PRINCIPAL_INVESTIGATOR
References: