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Chronic Obstr Lung DiseaseNCT07068269

Self-management Program in Patients With COPD

A study testing Self-Management Program and Routine Physical Therapy Exercises in people with Chronic Obstr Lung Disease, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevalent, preventable, and treatable condition known as chronic obstructive pulmonary disease (COPD) is characterized by ongoing respiratory symptoms and restricted airflow caused by abnormalities of the airways and alveoli. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Chronic Obstr Lung Disease
What is being tested?
Self-Management Program and Routine Physical Therapy Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 sitePakistan
Study dates
1 May 2025to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female
  • Age 40-65 years
  • Participants are eligible for the trial if they have an established diagnosis of COPD as defined by The Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria

Who cannot join

  • Unable to participate in the exercise component of the SPACE for COPD programme due to neurological, locomotive or psychiatric disability
  • Unable to participate in the exercise component of the SPACE for COPD programme due to other comorbidities where exercise would be a contraindication (e.g., unstable angina)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah Rehabilitation Clinic

    Lahore, Punjab Province, 54700

Other trials in Pakistan

About this study

Official title: Effects of Self-management Program of Activity Coping and Education on Quality of Life, Self-efficacy, Exercise Capacity and Anxiety and Depression in Patients With COPD

The prevalent, preventable, and treatable condition known as chronic obstructive pulmonary disease (COPD) is characterized by ongoing respiratory symptoms and restricted airflow caused by abnormalities of the airways and alveoli. Dyspnea, coughing, sputum production, and exacerbations are among the chronic respiratory symptoms of COPD. The objective of this study is to determine the effects of self-management program of activity coping and education on quality of life, self-efficacy, exercise capacity and anxiety and depression in patients with COPD. People with COPD should be given self-management support, according to national and international recommendations for managing the condition. Hospitalizations, COPD-specific health expenses, and health-related quality of life have all been demonstrated to improve when people with COPD receive interventions that promote self-management.

The study will be randomized clinical trial. Patients age between 45 to 60 years and diagnosed with COPD will be included. The Group A will receive self-management program of activity coping and education for 6 weeks whereas the Group B will receive routine physical therapy for 6 weeks. Pulmonary function testing will be used to evaluate the severity of COPD, St George Respiratory Questionnaire will be used to determine the quality of life, and Self-efficacy of patients will be assessed by COPD Self-efficacy Scale, 6-minute walk test will be used to find the exercise capacity of participants and anxiety and depression will be measured by the Hospital Anxiety and Depression Scale. Data will be analyzed using SPSS version 26.

Read the detailed description

The prevalent, preventable, and treatable condition known as chronic obstructive pulmonary disease (COPD) is characterized by ongoing respiratory symptoms and restricted airflow caused by abnormalities of the airways (bronchitis) and/or alveoli (emphysema), which are typically brought on by prolonged exposure to harmful particles or gases. Dyspnea, coughing, sputum production, and exacerbations are among the chronic respiratory symptoms of COPD. COPD is a global public health issue and one of the main causes of death and illness, particularly in developing nations. Approximately 30 million Americans are thought to suffer from COPD. Up to half of them are not even aware that they have it. The leading cause of chronic disease, COPD is expected to rank seventh globally in terms of disease burden by 2030. According to estimates, the prevalence of COPD in individuals over 40 is between 4 and 20% worldwide, and 6.3% in Asians. In addition, it is the fourth most frequent reason for hospitalization and the biggest financial burden among chronic illnesses affecting elderly patients.

People with COPD should be given self-management support, according to national and international recommendations for managing the condition. Hospitalizations, COPD-specific health expenses, and health-related quality of life have all been demonstrated to improve when people with COPD receive interventions that promote self-management. Although self-care is implied by the name "self," self-management always entails collaboration with a health care provider, who plays a supportive role. In general, COPD self-management programs are designed to give participants the skills necessary to follow long-term disease-specific medication regimes. The goals of SPACE for COPD, a Self-Management Program of Activity Coping and Education, are to help individuals with COPD manage daily tasks, reduce symptom load, encourage behavior changes that improve health, and improve psychological well-being. Programs for self-management should include physical activity, quitting smoking, managing social interactions, managing medications, and being able to identify and react to symptoms. The SPACE for COPD guidebook, which incorporates both general self-management techniques and disease-specific activities, serves as the framework for the program. Few studies have attempted to assess the cost-effectiveness of self-management programs for individuals with COPD. Some studies simply included the program's expenses. Self-management programs have been shown to be cost-effective in both lowering costs and improving patient outcomes.

This study is significant because it has the potential to concentrate on non-pharmacological interventions, such as self-management programs. A self-management program (SMP) for COPD is a patient-oriented approach that enables the patient to take charge of their condition through appropriate choice making, physical activity, emotional management, education on a continuous basis and encouraging adherence to the treatment plans. Such a program aims at enhancing the quality of life of the patient, and decreasing the frequency of exacerbations while increasing the overall functional ability of the patient. Moreover it reduces hospital admissions and emergency room visits which can alleviate pressure on healthcare systems. Self-management program (SMP) can raise awareness about COPD leading to greater community support. Improved management of symptoms can lead to a more active lifestyle for patients, benefiting overall societal health and productivity.

Being tested
Self-Management Program, Routine Physical Therapy Exercises
Keywords
Chronic obstructive pulmonary disease, Self-management program, Activity education and coping
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Management ProgramOther

    Week 1: Learn about COPD, practice pursed-lip and diaphragmatic breathing (2-3 sets, 10-15 reps, 2-3x/day), start 5-10 min light walking, conserve energy with frequent rests.

    Week 2: Understand benefits of activity and oxygen use, add seated marches/leg raises, walk 10-15 min, pace activities with rest breaks.

    Week 3: Begin strength exercises (sit-to-stand, wall push-ups, 2 sets of 10), increase walking to 15-20 min, practice relaxation for anxiety.

    Week 4: Focus on nutrition, walk 20-25 min, continue strength work, recognize flare-up signs, create action plan.

    Week 5: Seek social support, walk 25-30 min, add stretching (2-3x/week), track activity daily.

    Week 6: Set SMART goals, maintain daily walking 30 min, review coping strategies, add new activities if desired.

  • Routine Physical Therapy ExercisesOther

    Week 1: Practice pursed-lip and diaphragmatic breathing (2-3 sets, 10-15 breaths, 2-3x/day), start walking 5-10 min (3-5x/week), add gentle upper body stretches (20-30 sec holds, 2-3 reps).

    Week 2: Continue breathing exercises, increase walking slightly each session, maintain stretches 3-5x/week for flexibility.

    Week 3: Keep breathing routines, walk or cycle 15-20 min (4-5x/week), start sit-to-stand strength exercises (2-3 sets of 10-15 reps, 2-3x/week), keep stretching routine.

    Week 4: Maintain breathing drills, increase walking/cycling intensity if tolerated, continue strength work and flexibility exercises.

    Week 5: Keep up breathing exercises, walk/cycle 20-30 min (5x/week), do sit-to-stand exercises (3 sets of 10-15 reps, 3x/week), maintain upper body stretching.

    Week 6: Sustain daily breathing practice, aim for 30 min walking/cycling daily, continue strength and stretch exercises, adjust intensity as needed for long-term progress.

Study groups in NCT07068269
Study groupRoleWhat they receive
Group AExperimentalSelf-Management Program
Receives: Other: Self-Management Program
Group BActive comparatorRoutine Physical Therapy Exercise
Receives: Other: Routine Physical Therapy Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FEV1

    FEV1 (Forced Expiratory Volume in the first second) is a crucial pulmonary function test that measures the volume of air forcefully exhaled in the first second of a deep breath. It assesses how quickly lungs can empty, making it vital for diagnosing and monitoring obstructive diseases like COPD.

    Measured: Baseline, 3rd Week, 6th Week

  2. FVC

    Forced Vital Capacity (FVC) is a key spirometry measurement representing the total amount of air a person can forcibly exhale after taking a deep breath, typically measuring around liters in healthy adults. It is critical for diagnosing lung diseases (COPD, fibrosis), with low values indicating restrictive patterns or severe obstruction

    Measured: Baseline, 3rd Week, 6th Week

  3. PEF

    Peak Expiratory Flow (PEF) is a quick,, portable, and non-invasive pulmonary function test (PFT) measuring the maximum speed of exhalation, primarily used for diagnosing and monitoring asthma and chronic obstructive pulmonary disease (COPD). Using a peak flow meter, individuals record their highest reading to assess airway obstruction and manage medication.

    Measured: Baseline, 3rd Week, 6th Week

  4. St George Respiratory Questionnaire

    St. George's Respiratory Questionnaire (SGRQ) is a 50-item survey measuring health impairment in COPD/asthma patients, with scores from 0 to 100 (higher = worse health). It calculates three domain scores-Symptoms, Activity, Impacts-and a Total Score. A 4-unit change is considered clinically relevant.

    Measured: Baseline, 3rd Week, 6th Week

  5. COPD Self-Efficacy Scale

    The COPD Self-Efficacy Scale (CSES) measures a patient's confidence in managing breathing difficulties across various situations, typically using a 5-point Likert scale (5=Very confident, 1=Not at all confident). Total scores, or mean scores for subscales, indicate higher self-efficacy with higher values, often used to assess coping with physical exertion and emotional distress. Each of the 34 items (or 24/51 in some modified versions) is rated from 1 to 5. Total/Mean Score: Sum the responses and divide by the number of items (often 34) to get a mean score. A higher mean score indicates greater self-efficacy (confidence in managing symptoms). A mean score of 3 or higher suggests some degree of confidence.

    Measured: Baseline, 3rd Week, 6th Week

  6. 6-min walk Distance

    The 6-Minute Walk Test (6MWT) measures the distance (6MWD) a person can walk on a flat, hard surface in 6 minutes, with healthy adults typically covering 400 to 700 meters. It assesses functional capacity, with lower distances indicating increased risk for illness or, specifically for surgery, a higher risk of complications if under 500 meters.

    Measured: Baseline, 3rd Week, 6th Week

  7. Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-report tool (7 anxiety, 7 depression) scoring 0-21 per subscale. Each item is scored 0-3. Scores of 0-7 are considered normal, 8-10 borderline/mild, and 11-21 indicate a probable, clinically significant case.

    Measured: Baseline, 3rd Week, 6th Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2025
  2. Study start1 May 2025
  3. Primary completion30 Nov 2025
  4. Study completion30 Dec 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07068269
Sponsor's protocol ID
Firasha- REC/RCR&AHS 24/0366
Status last verified
Feb 2026
First submitted
7 Jul 2025
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bourne C, Houchen-Wolloff L, Patel P, Bankart J, Singh S. Self-management programme of activity coping and education-SPACE for COPD(C)-in primary care: a pragmatic randomised trial. BMJ Open Respir Res. 2022 Oct;9(1):e001443. doi: 10.1136/bmjresp-2022-001443.

    PubMed 36253020
  • Gupta N, Agrawal S, Chakrabarti S, Ish P. COPD 2020 Guidelines - what is new and why? Adv Respir Med. 2020;88(1):38-40. doi: 10.5603/ARM.2020.0080. No abstract available.

    PubMed 32153009

Questions about this trial

What is this clinical trial studying?

A study testing Self-Management Program and Routine Physical Therapy Exercises in people with Chronic Obstr Lung Disease, run by Riphah International University at 1 site in Pakistan.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1 (time frame: Baseline, 3rd Week, 6th Week). The study lists 7 primary outcomes in all. 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 NCT07068269, 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 25 Feb 2026.

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