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IRCT20210813052172N4 IRCT 2026-05-05 Shahid Beheshti University of Medical Sciences Assessment of the Effect of Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease Evaluation of Blood Inflammatory Markers and Their Comparison with Exercise Capacity Indices in Patients with Chronic Obstructive Pulmonary Disease Following Short-Term Pulmonary Rehabilitation 2026-06-22 anticipated 206 Pending https://irct.ir/trial/89809 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method used is permuted block randomization. For this purpose, two treatment groups, A and B, are defined in blocks as AB and BA. Then, numbers from a random table in the range 0 to 9 are considered. Numbers 0 to 4 are assigned to block AB, and numbers 5 to 9 are assigned to block BA. Random numbers are then selected from the table. If the number 0 appears, it corresponds to block AB, and therefore two individuals enter this block, such that the first individual receives treatment A and the second individual receives treatment B. In the same way, the treatment groups for the remaining participants are determined. Although in this method the number of observations in both groups will be equal, because of the small block sizes, there is a high probability that the person conducting the study may predict the treatment group assignment. To solve this problem, the randomization list is prepared before the start of the study by a blinded individual who is not part of the treatment team. Additionally, the block sizes will be increased, Blinding description: Given the nature of the study, which involves pulmonary rehabilitation, blinding of participants and therapists is not feasible, as patients will be aware of the type of treatment they receive. To minimize potential bias, the outcome assessor and the statistical data analyst will be blinded to group allocation. For this purpose, patient information will be provided to the outcome assessor and the statistical analyst in a coded format, and they will not have access to information regarding the type of intervention. Data analysis will be conducted solely based on the assigned codes. 3 Chronic obstructive pulmonary disease. Intervention 1: Intervention group: In addition to active care, patients receive education on care techniques and bedside physiotherapy, undergo a full rehabilitation program, and participate in a structured 10-session pulmonary rehabilitation program. Intervention 2: Control group: Patients receive active care and only basic respiratory education and care techniques (teaching sitting posture, simple diaphragmatic breathing, pursed-lip breathing), education and counseling (medication management, breathlessness management, teaching breathlessness control), and respiratory physiotherapy and bedside exercises (range-of-motion exercises and strengthening of respiratory muscles in a seated position in bed, isometric exercises, and prescribed exercises to maintain daily activities). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no furthor information.
public Maryam Sadat Mirenayat
Masih Daneshvari Hospital, Daarabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2612 5050 MirenayaT_M@yahoo.com Shahid Beheshti University of Medical Sciences scientific Masoumeh Zoghali
Masih Daneshvari Hospital, Daarabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2612 5050 masoumezoghali@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of COPD based on GOLD criteria Age over 18 years Stability of the patient’s clinical condition at the time of study entry Ability to perform functional tests 18 years no limit Both Exacerbation of the disease within the past two weeks Acute respiratory symptoms or infection during pulmonary rehabilitation period Incomplete training sessions for any reason Lack of willingness to cooperate in performing functional tests or completing questionnaires J44.9 Chronic obstructive pulmonary disease, unspecified Rehabilitation Rehabilitation Intervention group: In addition to active care, patients receive education on care techniques and bedside physiotherapy, undergo a full rehabilitation program, and participate in a structured 10-session pulmonary rehabilitation program. Control group: Patients receive active care and only basic respiratory education and care techniques (teaching sitting posture, simple diaphragmatic breathing, pursed-lip breathing), education and counseling (medication management, breathlessness management, teaching breathlessness control), and respiratory physiotherapy and bedside exercises (range-of-motion exercises and strengthening of respiratory muscles in a seated position in bed, isometric exercises, and prescribed exercises to maintain daily activities). Neutrophil-to-lymphocyte ratio. Timepoint: Before starting pulmonary rehabilitation and after completing 10 days of pulmonary rehabilitation. Method of measurement: Complete Blood Count. Platelet-to-lymphocyte ratio. Timepoint: Before starting pulmonary rehabilitation and after completing 10 days of pulmonary rehabilitation. Method of measurement: Complete Blood Count. Erythrocyte sedimentation. Timepoint: Before starting pulmonary rehabilitation and after completing 10 days of pulmonary rehabilitation. Method of measurement: Complete Blood Count. Exercise capacity. Timepoint: Before initiation pulmonary rehabilitation and after 10 days pulmonary rehabilitation. Method of measurement: Six minute walk test. Strength and endurance of the lower limb muscles. Timepoint: Before starting pulmonary rehabilitation and after completing 10 days of pulmonary rehabilitation. Method of measurement: Sit to stand test. Dyspnea. Timepoint: Before starting pulmonary rehabilitation and after completing 10 days of pulmonary rehabilitation. Method of measurement: Borg scale questionnaire. Fatigue. Timepoint: Before starting pulmonary rehabilitation and after completing 10 days of pulmonary rehabilitation. Method of measurement: Borg scale questionnaire. Quality of life. Timepoint: Before starting pulmonary rehabilitation and after completing 10 days of pulmonary rehabilitation. Method of measurement: St. George's Questionnaires and Chronic Obstructive Pulmonary Disease Assessment Test (CAT). Shahid Beheshti University of Medical Sciences Approved 2026-02-17 Ethics Committee of School of Medicine, Shahid Beheshti University of Medical Sciences Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)