Chronic Obstructive Pulmonary DiseaseRCTNCT07913334
Impact of Nurse-Led Pulmonary Rehabilitation on Dyspnea, Fatigue and Self-Efficacy in COPD Patients
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Health Sciences Lahore.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition characterized by airflow limitation, dyspnea, and fatigue, significantly impairing quality of life. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2026to 16 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed cases of COPD, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
- Adults aged > 40 years (WHO, 2023; GOLD, 2024).
- Both genders (male \& female).
- Hemodynamically stable (vital signs: BP > 90/60 mmHg, heart rate between 60-100 bpm).
- Dyspnea Grade ≥ 2 on the mMRC Dyspnoea Scale.
- Oxygen saturation (SpO2) ≥ 88% on room air.
Who cannot join
- Comorbid respiratory diseases (e.g., asthma, pulmonary fibrosis).
- Severe cardiovascular or neurological conditions.
- Recent hospitalization for COPD or other respiratory issues (within 4 weeks).
- Pregnancy or planning pregnancy during the study.
- Unable or unwilling to comply with the study protocol.
- Terminal illness or life expectancy < 6 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Nurse-Led Pulmonary Rehabilitation on Dyspnea, Fatigue and Self-Efficacy in Chronic Obstructive Pulmonary Disease Patients in Tertiary Care Hospital, Lahore
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.
Read the detailed description
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation
- Keywords
- COPD, Nurse-led, Dyspnea, Fatigue, Self Efficacy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
Also called nurse-led pulmonary rehabilitation, disease education, breathing exercises, strengthening exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group receiving nurse led pulmonary rehabilitation including disease education, breathing and strengthening exercises Receives: Other: Pulmonary rehabilitation |
| Control group | No intervention | Control group receiving standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (2)
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
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start14 Oct 2026 (estimated)
- Primary completion16 Mar 2027 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madiha Shahzadi, University of Health Sciences Lahore
- Investigators
- Samina Kausar Prof, PhD Nursing, Study director, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913334
- Sponsor's protocol ID
- UHS786
- Acronym
- RCT
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sadek Ramadan, S. and Nagah Hasan Mohamed, S., 2021. Effect of Nurse-Led Pulmonary Rehabilitation Program on Dyspnea and Fatigue for Patients with Chronic Obstructive Pulmonary Disease. Egyptian Journal of Health Care, 12(2):608-629.
Aranburu-Imatz A, Lopez-Carrasco JC, Moreno-Luque A, Jimenez-Pastor JM, Valverde-Leon MDR, Rodriguez-Cortes FJ, Arevalo-Buitrago P, Lopez-Soto PJ, Morales-Cane I. Nurse-Led Interventions in Chronic Obstructive Pulmonary Disease Patients: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Jul 26;19(15):9101. doi: 10.3390/ijerph19159101.
PubMed 35897469
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nurse-Led Pulmonary Rehabilitation on Dyspnea, Fatigue and Self-Efficacy in Chronic Obstructive Pulmonary Disease Patients in Tertiary Care Hospital, Lahore
- ClinicalTrials.gov ID
- NCT07913334
- Acronym / sponsor ID
- RCT / UHS786
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Nurse-led, Dyspnea, Fatigue, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pulmonary rehabilitationIntervention group receiving nurse led pulmonary rehabilitation including disease education, breathing and strengthening exercises |
| Control group | No intervention | –Control group receiving standard care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed cases of COPD, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
- Adults aged > 40 years (WHO, 2023; GOLD, 2024).
- Both genders (male \& female).
- Hemodynamically stable (vital signs: BP > 90/60 mmHg, heart rate between 60-100 bpm).
- Dyspnea Grade ≥ 2 on the mMRC Dyspnoea Scale.
Key exclusion criteria (6 listed)
- Comorbid respiratory diseases (e.g., asthma, pulmonary fibrosis).
- Severe cardiovascular or neurological conditions.
- Recent hospitalization for COPD or other respiratory issues (within 4 weeks).
- Pregnancy or planning pregnancy during the study.
- Unable or unwilling to comply with the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationAlso: nurse-led pulmonary rehabilitation, disease education, breathing exercises, strengthening exerciseThe 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. | Other | Intervention group |
Primary outcome
Dyspnea
Time frame: 12 weeks
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
2 secondary outcomes
Fatigue
Time frame: 12 weeks
Self efficacy
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- BackgroundSadek Ramadan, S. and Nagah Hasan Mohamed, S., 2021. Effect of Nurse-Led Pulmonary Rehabilitation Program on Dyspnea and Fatigue for Patients with Chronic Obstructive Pulmonary Disease. Egyptian Journal of Health Care, 12(2):608-629.
- Background: PubMed 35897469Aranburu-Imatz A, Lopez-Carrasco JC, Moreno-Luque A, Jimenez-Pastor JM, Valverde-Leon MDR, Rodriguez-Cortes FJ, Arevalo-Buitrago P, Lopez-Soto PJ, Morales-Cane I. Nurse-Led Interventions in Chronic Obstructive Pulmonary Disease Patients: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Jul 26;19(15):9101. doi: 10.3390/ijerph19159101.
- Educational GuidanceLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samina Kausar Prof, PhD Nursing study director
University of Health Sciences Lahore
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Health Sciences Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madiha Shahzadi, MS Nursing (+923452929254, madihashahzadi786@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07913334, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.