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

NCT06592742 | Completed

• 1 other identifier: 4989
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis (CF)

Keywords

cystic fibrosis; mental health; sleep quality; anxiety and depression; progressive muscle relaxation

Outcome Measures

Primary Outcomes (2)

• 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.

  At inclusion, at 21 days, at 48 days.

• Mental Health

  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).

  At inclusion, at 21 days, at 48 days.

Secondary Outcomes (3)

• 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.

Study Arms (2)

Control group (PR alone)

ACTIVE COMPARATOR

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.

Behavioral: Pulmonary rehabilitation (alone)

Intervention group (PR + PMR)

EXPERIMENTAL

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.

Behavioral: Intervention group (PR + PMR)

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.

Also known as: PR

Control group (PR alone)

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.

Also known as: PMR

Intervention group (PR + PMR)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Confirmed cystic fibrosis diagnosis based on clinical, genetic, or sweat chloride testing, as defined by established CF diagnostic criteria.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara: lead

Study Sites (1)

Hospital of Infectious Disease and Pneumoftiziology Victor Babes

Timișoara, 300310, Romania

Location

MeSH Terms

Conditions

Cystic Fibrosis; Psychological Well-Being; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Interventions

Single Person

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Personal Satisfaction; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Alexandru Crisan, Phd

  University of Medicine and Pharmacy "Victor Babes" Timisoara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 13, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)