- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07716696
Effects of Pulmonary Rehabilitation Versus Standard Care in Patients With Pericarditis
Comparative Effects of Pulmonary Rehabilitation Versus Standard Care on Pain, Dyspnea, Cough Severity, Fatigue, and Anxiety in Patients With Pericarditis: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial evaluates the comparative effectiveness of pulmonary rehabilitation and standard care in patients diagnosed with pericarditis. Participants are allocated into two groups: an intervention group receiving pulmonary rehabilitation and a control group receiving standard medical care.
Pulmonary rehabilitation includes breathing exercises, aerobic training, and patient education aimed at improving respiratory efficiency and reducing symptom burden. Such programs are widely used to improve functional capacity and quality of life in clinical populations [1].
Outcome measures include pain intensity, dyspnea, cough severity, fatigue, and anxiety, assessed using validated tools such as the Visual Analog Scale (VAS) and McMaster Cough Severity Questionnaire.
Assessments will be conducted at baseline and after completion of the intervention period.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- ULTH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Diagnosed with pericarditis Age between 18-65 years Both male and female participants Medically stable Able to participate in rehabilitation Willing to provide informed consent
Exclusion Criteria:
Severe cardiovascular or respiratory instability Other major pulmonary diseases Recent surgery or trauma Neurological disorders affecting participation Unwillingness to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pulmonary Rehabilitation Group
Participants receive a structured pulmonary rehabilitation program including breathing exercises, aerobic training, and education sessions.
|
A structured program including breathing exercises, aerobic conditioning, and patient education administered over multiple weeks.
|
|
Active Comparator: Standard Care Group
Routine clinical management as prescribed by the treating physician without additional rehabilitation protocol.
|
Routine clinical management as prescribed by the treating physician without additional rehabilitation protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea Severity
Time Frame: Baseline and 8 weeks
|
Measured using Visual Analog Scale (VAS)
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Baseline and 8 weeks
|
Measured using VAS
|
Baseline and 8 weeks
|
|
Cough Severity
Time Frame: Baseline and 8 weeks
|
Measured using McMaster Cough Severity Questionnaire
|
Baseline and 8 weeks
|
|
Fatigue
Time Frame: Time Frame: Baseline and 8 weeks
|
Measured using VAS or standardized fatigue scale
|
Time Frame: Baseline and 8 weeks
|
|
Anxiety
Time Frame: Time Frame: Baseline and 8 weeks
|
Measured using a validated anxiety scale
|
Time Frame: Baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Cardiovascular Diseases
- Mental Disorders
- Heart Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Anxiety Disorders
- Fatigue
- Pericarditis
- Cough
- Dyspnea
- Chest Pain
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- UOL/IREB/25/15/03/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pericarditis
-
Mayo ClinicWithdrawn
-
Assistance Publique Hopitaux De MarseilleCompletedInfective PericarditisFrance
-
Université de SherbrookeUnknown
-
Children's Healthcare of AtlantaTerminatedCongenital DisordersUnited States
-
Rabin Medical CenterTerminated
-
Virginia Commonwealth UniversityTerminated
-
Cardiol Therapeutics Inc.CompletedRecurrent PericarditisUnited States
-
Kiniksa Pharmaceuticals International, plcKiniksa Pharmaceuticals, GmbHRecruitingHeart Diseases | Pericarditis | Recurrent PericarditisUnited States, Italy, France, Canada, United Kingdom, Greece, Poland, Spain, Serbia
-
Zomagen Biosciences Ltd.RecruitingRecurrent PericarditisUnited States, Canada
-
Cardiol Therapeutics Inc.RecruitingRecurrent PericarditisUnited States, Italy, Canada, Greece
Clinical Trials on Pulmonary Rehabilitation
-
Universidade Federal de Santa MariaCompletedChronic Obstructive Pulmonary DiseaseBrazil
-
Faculty of Medicine, SousseCompletedChronic Obstructive Pulmonary DiseaseTunisia
-
Istanbul Medipol University HospitalRecruitingLung Diseases | Bronchiectasis | Lung Diseases, Interstitial | Pulmonary RehabilitationTurkey
-
Beijing Chao Yang HospitalBeijing Municipal Health CommissionNot yet recruiting
-
CHU de ReimsNot yet recruitingChronic Obstructive Pulmonary Disease (COPD)France
-
The Children's Hospital of Zhejiang University...Not yet recruiting
-
ADIR AssociationEuropean Union; Hopital La Musse; Groupe Hospitalier du Havre; Centre Hospitalier... and other collaboratorsRecruitingChronic Obstructive Pulmonary Disease (COPD)France
-
La Trobe UniversityMonash University; The Alfred; Austin HealthCompletedChronic Obstructive Pulmonary DiseaseAustralia
-
Aveiro UniversityCentro Hospitalar do Baixo VougaRecruitingChronic Obstructive Pulmonary Disease | Interstitial Lung DiseasePortugal
-
National Cheng-Kung University HospitalCompletedTelerehabilitation | Pulmonary Rehabilitation | Compliance, Patient | COPD | Cardiopulmonary Exercise TestTaiwan