An interventional study of Pulmonary rehabilitation in Chronic Obstructive Pulmonary Disease, sponsored by University of Health Sciences Lahore. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Supportive care
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition characterized by airflow limitation, dyspnea, and fatigue, significantly impairing quality of life. Globally, COPD is a leading cause of morbidity and mortality, with its burden disproportionately affecting low- and middle-income countries such as Pakistan, where healthcare resources are limited and structured rehabilitation programs are scarce. Despite evidence supporting pulmonary rehabilitation (PR) as an effective intervention for improving physical capacity, symptom control, and quality of life, its implementation in Pakistan remains minimal. Nurse-led PR programs, which integrate education, and exercise have demonstrated positive outcomes internationally; however, their feasibility and effectiveness in resource-limited settings are largely unexplored. Thus, the aim of this study is to assess the impact of a nurse-led PR program in improving dyspnea, fatigue and self-efficacy in patients with COPD. Adults (aged ≥40 years) meeting eligibility criteria will be randomly allocated to an intervention or control group. Prior to the start of the intervention, baseline data will be collected from both groups using Modified Medical Research Council Dyspnea, Fatigue Severity and COPD Self-Efficacy Scales to assess the severity of dyspnea, fatigue and level of COPD self-efficacy. The intervention group will be provided with a nurse-led structured PR program by the researcher which will include COPD education, breathing and strengthening exercises for 12 weeks. The first sessions will be conducted during outpatient visits and will be followed up by weekly telephonic reminders and bi-weekly face-to-face meet-up to ensure continued adherence and individualized guidance. While, the control group will receive standard care which include routine medical management. After completion of 12-week intervention, the same scales will be used to evaluate changes in the outcome variables i.e. dyspnea, fatigue and COPD self-efficacy. Descriptive statistics will be used to summarize the demographic and clinical characteristics. To evaluate the effectiveness of the pulmonary rehabilitation program on dyspnea and fatigue status, Chi-square / Fisher's exact test will be used to compare the post-intervention results between the two groups. Independent sample t-test / Mann-Whitney test will be used to compare the self-efficacy score between the intervention and control groups. The findings of this study are expected to provide empirical evidence of the effectiveness of nurse-led pulmonary rehabilitation and inform evidence-based healthcare policies. The findings may also support the integration of nurse-led PR into routine COPD care as a feasible, cost-effective strategy to improve symptom management and quality of life among patients with COPD.
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition characterized by airflow limitation, dyspnea, and fatigue, significantly impairing quality of life. Globally, COPD is a leading cause of morbidity and mortality, with its burden disproportionately affecting low- and middle-income countries such as Pakistan, where healthcare resources are limited and structured rehabilitation programs are scarce. Despite evidence supporting pulmonary rehabilitation (PR) as an effective intervention for improving physical capacity, symptom control, and quality of life, its implementation in Pakistan remains minimal. Nurse-led PR programs, which integrate education, and exercise have demonstrated positive outcomes internationally; however, their feasibility and effectiveness in resource-limited settings are largely unexplored.
This study aims to evaluate the effectiveness of a nurse-led pulmonary rehabilitation program on self-efficacy, dyspnea, and fatigue among COPD patients in Pakistan. The research will employ a randomized controlled trial (RCT) design, enrolling adults aged 40 years or older diagnosed with moderate to severe COPD. Participants will be randomly assigned to either an intervention group receiving a structured 12-week nurse-led PR program or a control group receiving routine care. The intervention will include weekly sessions focusing on disease education, breathing exercises and physical activity delivered through OPD visits and telephonic follow-ups. Each pulmonary rehabilitation session will last between 60 to 90 minutes, incorporating exercise training and educational components. Researcher will provide individualized guidance and monitor adherence through patient regular check-ins. Regular check-ins will occur bi-weekly and involve either a phone call or in-person meeting to discuss the patient's progress, answer any questions, and address concerns. During these sessions, the researcher will evaluate the patient's adherence to the program and provide further guidance or adjustments to the rehabilitation plan.
Primary outcomes-self-efficacy, Dyspnea, and fatigue-will be assessed using validated tools: the COPD Self-Efficacy Scale (CSES), Modified Medical Research Council (mMRC) Dyspnea Scale, and Fatigue Severity Scale (FSS). The intervention will last 12 weeks, followed by post test. The 12-week duration of the pulmonary rehabilitation program is based on established evidence that suggests this period is sufficient for significant improvement in COPD symptoms, exercise capacity, and overall well-being. Studies have demonstrated that a 12-week program leads to reduced Dyspnea, improved physical fitness, and enhanced quality of life for patients with COPD. To evaluate the effectiveness of the pulmonary rehabilitation program on Dyspnea and fatigue status, Chi-square / Fisher's exact test will be used to compare the post-intervention results between the two groups. Independent sample t-test / Mann-Whitney test will be used to compare the self-efficacy score between the intervention and control groups.
The anticipated results include reduced Dyspnea severity, alleviated fatigue and improved self-efficacy in the intervention group compared to controls. These findings will provide evidence for the feasibility and effectiveness of nurse-led PR programs in Pakistan, offering a cost-effective strategy to enhance COPD management in resource-limited settings. The study's outcomes have the potential to inform healthcare policy, promote integration of nurse-led interventions into chronic care models, and ultimately improve quality of life for COPD patients.
4,263 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 714 are open to participants now.
This study's planned enrollment of 74 is close to the median of 70 across 3,016 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University of Health Sciences Lahore is the lead sponsor of 82 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Intervention group receiving nurse led pulmonary rehabilitation including disease education, breathing and strengthening exercises
Other: Pulmonary rehabilitation
Control group receiving standard care
The nurse-led pulmonary rehabilitation program will be conducted in intervention group following the guidelines outlined in the COPD Handbook (Lung Health Foundation, 2021), which provides comprehensive education on COPD definition, signs and symptoms and home based rehabilitation strategies. Each pulmonary rehabilitation session will last between 60 to 90 minutes, incorporating exercise training for 20-45 minutes and educational components for 45-60 minutes, as supported by previous studies and clinical guidelines.
Also known as: nurse-led pulmonary rehabilitation, disease education, breathing exercises, strengthening exercise
Dyspnea
Dyspnea is defined as the sensation of breathlessness, and in this study, it will be measured using the Modified Medical Research Council (mMRC) Dyspnea Scale, which classifies breathlessness severity from 0 (no breathlessness) to 4 (severe breathlessness) Higher score indicates greater dyspnoea and lower score indicates improvement in dyspnoea
Time frame: 12 weeks
Fatigue
The Fatigue Severity Scale (FSS), developed by Krupp and LaRocca (1989), is a 9-item scale designed to measure the severity of fatigue and its impact on daily functioning. Each item is rated on a 7-point Likert scale, with higher scores indicating greater fatigue severity. The Cronbach's alpha of 0.88 demonstrates the scale's excellent internal consistency. The total score ranges from 9 to 63, Based on the FSS scoring system, low fatigue is defined as a total score ranging from 9 to 36, while high fatigue is defined as a score ranging from 37 to 63. This classification will help in understanding the severity of fatigue in participants and the potential impact on their daily lives
Time frame: 12 weeks
Self efficacy
The COPD Self-Efficacy Scale (CSES), developed by Wigal et al. (1991), is a 34-item tool designed to assess a patient's confidence in managing their COPD symptoms across various situations. Using a 5-point Likert scale, patients rate their confidence from "Very confident" to "Not at all confident" in handling challenges related to physical exertion, emotional stress, environmental factors, and behavioral risks. Higher scores indicate greater self-efficacy.
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Oct 2026; primary completion for Mar 2027, 5 months later.
Of 798 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 5 months is below that.
Counting every sponsor, half of 850 studies reached it within 24 months; a quarter within 11 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Lahore