Evaluation of Blood Inflammatory Markers and Their Comparison with Exercise Capacity Indices in Patients with Chronic Obstructive Pulmonary Disease Following Short-Term Pulmonary Rehabilitation

Evaluation of Blood Inflammatory Markers and Their Comparison with Exercise Capacity Indices in Patients with Chronic Obstructive Pulmonary Disease Following Short‑Term Pulmonary Rehabilitation

In this study, which will be conducted in phase III of a clinical trial, a total of 206 patients will be enrolled according to the inclusion and exclusion criteria. After obtaining written informed consent, they will be randomly assigned (using permuted block randomization) in a single‑blind manner into two groups: intervention and control.

This study is a phase III clinical trial conducted in a randomized (using permuted block randomization) and single‑blind manner on patients with chronic obstructive pulmonary disease (COPD) who are referred to Masih Daneshvari Hospital.

The inclusion criteria for the study include a definite diagnosis of chronic obstructive pulmonary disease based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, age above 18 years, stability of the patient’s clinical condition at the time of entry into the study, and the ability to perform functional tests. Patients who develop acute respiratory symptoms or infection during the rehabilitation period, patients with a history of exacerbation, or those who are unwilling to cooperate will be excluded from the study.

In the control group, patients receive respiratory physiotherapy and bedside exercises. In the intervention group, in addition to active care, training in caregiving techniques, and bedside physiotherapy, patients receive the full rehabilitation program and participate in a pulmonary rehabilitation program.

Platelet-to-lymphocyte ratio, erythrocyte sedimentation rate, neutrophil-to-lymphocyte ratio

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.

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