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IRCT20250428065499N1 IRCT 2025-05-15 Riphah international university of Lahore Rehabilitation exercises to improve breathing and quality of life in asthma patients Effects of multimodal rehabilitation exercises on dyspnea and quality of life among asthmatic patients. 2024-07-30 anticipated 64 Complete https://irct.ir/trial/83188 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study will use single blinding, where participants will be unaware of their group allocation (intervention or control). The researchers conducting the interventions and assessments will not be blinded to the group allocation. This blinding method aims to reduce participant bias in reporting outcomes and responses, while recognizing that the researchers involved in the study cannot be blinded due to the nature of the intervention, Randomization description: Participants will be randomly assigned to the intervention or control group using a computer-generated random number sequence. Allocation concealment will be ensured using sealed, opaque, and sequentially numbered envelopes, Blinding description: The outcome assessor will be blinded to the group allocation of participants. Due to the nature of the intervention, participants and the therapist will not be blinded. 3 Asthma is a chronic inflammatory disease of the airways characterized by symptoms such as wheezing, shortness of breath, chest tightness, and coughing. This study focuses on individuals with mild to moderate asthma eligible for pulmonary rehabilitation, aiming to improve respiratory function, exercise tolerance, and quality of life.". Intervention 1: Intervention group:Description: An 8-week multidisciplinary program including:Supervised exercise-based pulmonary rehabilitationProgressive muscle relaxation sessionsNutritional counselingGoals: Improve pulmonary function, dyspnea, psychological well-being, and quality of lifeFrequency & Duration: 3 sessions per week at the rehab center, for 8 weeksAssessment Points: Baseline, post-8 weeks, and 3-month follow-up. Intervention 2: Control group: Description: Patients receive standard asthma care as per current clinical guidelines without additional rehabilitation sessionsGoals: Serve as comparison for evaluating the IRG programFrequency & Duration: As determined by standard clinical practiceAssessment Points: Same as intervention group (baseline, post-8 weeks, and 3-month follow-up). Yes - There is a plan to make this available What will be shared: The dataset will include all collected deidentified individual participant data (IPD) related to the study. This will include baseline demographic data, clinical data, and outcome measures such as pulmonary function, dyspnea severity, anxiety and depression scores, and quality of life questionnaires. When: The deidentified IPD will become available 6 months after the publication of the study results. It will remain accessible for a period of 5 years after the publication To whom: The deidentified IPD will be available to researchers working in academic institutions, non-profit organizations, and other research-focused entities. Business professionals may also apply if their research is in a related field and aligned with the study’s objectives. Conditions: The data will be available for academic research, focusing on analysis related to asthma management, rehabilitation, and respiratory function. Requests for data use will be reviewed by the research committee to ensure they meet ethical standards and the scope of the study. Where to obtain: The data will be available upon request through the hospital’s research office. How to obtain: Interested researchers will need to submit a formal request through email, including the purpose of the analysis, the methodology, and a plan for data handling. Requests will be reviewed by the study’s research committee, which will take 4–6 weeks to process. Comments: The data will be made available in a secure, accessible format, and requests will be handled in compliance with data privacy regulations.
public Dr. Muneeb khan
26-M GULBERG 3, LAHORE
Lahore Pakistan 54660 009 30 00720887 research.frahslhr@riphah.edu.pk Riphah international university of Lahore scientific Dr. Muneeb
26-M GULBERG 3, LAHORE
Lahore Pakistan 54660 009 30 00720887 research.frahslhr@riphah.edu.pk Riphah international university of Lahore Pakistan Age 20-40 years Diagnosed with asthma Asthma patients eligible for pulmonary rehabilitation should have mild to moderate asthma with PEFR ≥ 40%, oxygen saturation ≥ 90%, and occasional use of accessory muscles Presence of respiratory symptoms such as wheezing, shortness of breath, or asthma Willingness to participate in the study Ability to perform and complete the 6-Minute Walk Test (6MWT) 20 years 40 years Both Cognitive impairment Severe co-morbidities indicating greater illness morbidity than asthma alone Complications from any other pulmonary diseases in addition to asthma Locomotor system problems that interfere with the evaluation/intervention protocol Irregular use of medication prescribed by a physician Significant cardiovascular diseases, pregnancy, or lactation Inability to perform physical exercise or engage in rehabilitation activities Patients unable or unwilling to attend training sessions regularly J45. 9 Asthma Rehabilitation Rehabilitation Intervention group:Description: An 8-week multidisciplinary program including:Supervised exercise-based pulmonary rehabilitationProgressive muscle relaxation sessionsNutritional counselingGoals: Improve pulmonary function, dyspnea, psychological well-being, and quality of lifeFrequency & Duration: 3 sessions per week at the rehab center, for 8 weeksAssessment Points: Baseline, post-8 weeks, and 3-month follow-up. Control group: Description: Patients receive standard asthma care as per current clinical guidelines without additional rehabilitation sessionsGoals: Serve as comparison for evaluating the IRG programFrequency & Duration: As determined by standard clinical practiceAssessment Points: Same as intervention group (baseline, post-8 weeks, and 3-month follow-up) Dyspnea Severity :Measures the intensity of breathlessness during activities. Timepoint: Baseline, post-intervention (8 weeks), and 3-month follow-up. Method of measurement: Modified Borg Dyspnea Scale. Anxiety and Depression Levels:Evaluates psychological symptoms related to asthma. Timepoint: Baseline, post-intervention (8 weeks), and 3-month follow-up. Method of measurement: Hospital Anxiety and Depression Scale (HADS). Quality of Life:Assesses the impact of asthma on daily life and well-being. Timepoint: Baseline, post-intervention (8 weeks), and 3-month follow-up. Method of measurement: Asthma Quality of Life Questionnaire (AQLQ). Functional Capacity:Measures physical endurance and capacity to perform exercise. Timepoint: Baseline and post-intervention (8 weeks). Method of measurement: 6-Minute Walk Test (6MWT). Riphah international university of Lahore Approved 2025-06-05 Research and ethics committee 26-M GULBERG 3,LAHORE Sialkot Punjab Pakistan