Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592742
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Progressive Muscle Relaxation in Pulmonary Rehab for Quality of Life Mental Health and Sleep in Cystic Fibrosis
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIME-CF
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
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 studys 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None