Efficacy Of Inpatient Pulmonary Rehabilitation Program In Elderly Patients With Acute Exacerbation Of COPD
Phase: NA
Conditions: COPD Received PR, Elderly (People Aged 65 or More), COPD, COPD Acute Exacerbation
Sponsor: Al-Azhar University

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Cover letter 
 
Unique Protocol ID: INPATIENT COPD REHABILITATION 
Official Title: Efficacy Of Inpatient Pulmonary Rehabilitation Program In 
Elderly Patients with Acute Exacerbation Of COPD   
Release date:8-5-2025

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EFFICACY OF INPATIENT PULMONARY REHABILITATION PROGRAM 
IN ELDERLY PATIENTS WITH ACUTE EXACERBATION OF COPD: A 
RANDOMIZED CONTROL TRIAL. 
Introduction 
Chronic Obstructive Pulmonary Disease (COPD) is now one of the top three 
causes of death worldwide, and 90% of these deaths occur in low- and middle-
income countries (LMICs) [1, 2] . Previous studies illustrated that older adults with 
COPD have a high risk of experiencing AECOPD, which typically leads to 
decreased lung function, an increased incidence of respiratory failure, and even 
death [3]. Acute exacerbation (AE) of COPD (AECOPD) is defined as episodes of 
acute worsening of respiratory symptoms (such as dyspnea, coughing, and sputum 
production) that require additional therapy [4]. AECOPD is responsible for 
patients’ clinical deterioration. 
 
Patients requiring hospitalisation are associated with poor outcomes, including 
accelerated declines in muscle strength and lung function, a reduced health status 
and quality of life (QOL), accelerated disease progression, a significant risk of 
recurrent exacerbation, and an increased risk of mortality [5] . Increase population 
ageing, in addition to a large percentage of elderly experiencing AECOP, will lead 
to extra efforts in healthcare systems, in addition to high costs of medical care 
services. Seeking cost-effective ways is the aim of international societies 
concerning COPD. 
 
 
The study aimed to identify the effect of early pulmonary rehabilitation in elderly 
patients with Acute exacerbation (AE) of COPD (AECOPD) on exercise tolerance, 
dyspnea, sleep quality, fatigue, and time from hospital admission till discharge 
from the hospital. 

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Methods 
Participants 
A prospective, supervised, blinded randomised controlled trial (RCT) will be 
conducted at Alzahraa University Hospital, in the inpatient department of Chest 
disease, Cairo, Egypt. Participants were allocated to the two groups using 
computer-generated random allocation sequences. The codes were determined by 
using serially numbered block sizes will be kept in sealed and opaque envelopes in 
a locked office. Participants’ healthcare providers were blinded to the group 
assignment. 
Sample size calculation. 
 
Before the participants were included in the study, the sample size was 
measured using Epi Info™ program version 7. 2. Based on the previous study [6]. 
Inclusion criteria 
Patients with mild to moderate acute exacerbation of COPD in both genders 2) 
were older than 65 years, 3) were in clear consciousness, 4) had been diagnosed 
with shortness of breath or dyspnea that was not caused by heart disease, 
pneumothorax, or pulmonary oedema 
Exclusion criteria were 1) systolic blood pressure lower than 90 mmHg, 2) an 
unstable psychological status, hemoptysis, pneumothorax, pulmonary oedema, and 
the use of a respirator 
Ethical considerations 
The study was approved by the ethical committee of the Faculty of Medicine 
for Girls- Al-Azhar University, Cairo, Egypt, number (2723). The principal 
investigator explained to the patients the objectives, the implementation process, 

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Inclusion criteria, and exclusion criteria of the study. In addition, the patients were 
informed that they could withdraw from the study at any time if they felt unwell, 
and they were enrolled only after signing informed consent forms 
Assessment 
Diagnosis of COPD 
The presence of non-fully reversible airflow obstruction (FEV1/FVC < 0.7 post-
bronchodilation) measured by spirometry confirms the diagnosis of COPD [7]. The 
patients were admitted to the hospital for over 24 hours and diagnosed with COPD 
based on the Global Initiative for Obstructive Lung Disease guideline. The presence 
of non-fully reversible airflow obstruction (FEV1/FVC < 0.7 post-bronchodilation) 
measured by spirometry confirms the diagnosis of COPD [7]. Patients medically 
controlled by medication recommended by GOLD2024. 
The diagnostic approach to AECOPD is confirmed based on the clinical setting and 
severity of the exacerbation. After history and examinations, including oximetry, 
sputum culture, chest X-ray [8]. 
 
Fatigue Severity Scale (FSS) 
The Fatigue Severity Scale (FSS) is a nine-item self-administered questionnaire. 
Each item is scored between 1 and 7, and a lower total score indicates a decrease in 
fatigue [9]. 
Exercise Program 
Group A: They will Perform a physical therapy program that will be 
completed two daily sessions till discharge from the hospital, starting from 
randomization until hospital discharge. Administered twice per day, seven 
times per week,  

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Group B: A control group will only receive medical treatment from hospital 
admission until discharge. 
 
 
REFERENCES 
 
1. 
Halpin, D.M.G., et al., The GOLD Summit on chronic obstructive pulmonary disease 
in low- and middle-income countries. The International Journal of Tuberculosis and 
Lung Disease, 2019. 23(11): p. 1131-1141. 
2. 
Meghji, J., et al., Improving lung health in low-income and middle-income countries: 
from challenges to solutions. The Lancet, 2021. 3G7(10277): p. 928-940. 
3. 
Jurado Gámez, B., et al., Home intervention and predictor variables for 
rehospitalisation in chronic obstructive pulmonary disease exacerbations. Arch 
Bronconeumol, 2013. 4G(1): p. 10-4. 
4. 
Wedzicha, J.A.E.C.-C., et al., Management of COPD exacerbations: a European 
Respiratory Society/American Thoracic Society guideline. Eur Respir J, 2017. 4G(3). 
5. 
Tung, L.F., et al., Effect of high-ffow nasal therapy during early pulmonary 
rehabilitation in patients with severe AECOPD: a randomized controlled study. 
Respir Res, 2020. 21(1): p. 84. 
6. 
Mohammed, M., et al., Efficacy of threshold inspiratory muscle trainer versus 
diaphragmatic plus pursed lip breathing in occupational COPD. Beni-Suef University 
Journal of Basic and Applied Sciences, 2023. 12. 
7. 
Report, G., GLOBAL STRATEGY FOR PREVENTION, DIAGNOSIS AND MANAGEMENT 
OF COPD. 2024 GOLD Report, 2024. 
8. 
Ko, F.W., et al., Acute exacerbation of COPD. Respirology, 2016. 21(7): p. 1152-65. 
9. 
Armutlu, K., et al., The validity and reliability of the Fatigue Severity Scale in Turkish 
multiple sclerosis patients. Int J Rehabil Res, 2007. 30(1): p. 81-5. 
Informed Consent 
 
I freely and voluntarily consent to participate in the research program under the 
direction of researcher/ Marwa Mohammed. A thorough description of the 
procedure has been provided, and I understand that I can withdraw my consent 
and discontinue my participation in this research at any time without prejudice. 
 
 
 
 
Date……………………. Participant’s signature…………………….