Self-management Program in Patients With COPD

NCT07068269 | Completed

• 1 other identifier: Firasha- REC/RCR&AHS 24/0366
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstr Lung Disease

Keywords

Chronic obstructive pulmonary disease; Self-management program; Activity education and coping

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline, 3rd Week, 6th Week

• 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

  Baseline, 3rd Week, 6th Week

• 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.

  Baseline, 3rd Week, 6th Week

• 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.

  Baseline, 3rd Week, 6th Week

• 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.

  Baseline, 3rd Week, 6th Week

• 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.

  Baseline, 3rd Week, 6th Week

• 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.

  Baseline, 3rd Week, 6th Week

Study Arms (2)

Group A

EXPERIMENTAL

Self-Management Program

Other: Self-Management Program

Group B

ACTIVE COMPARATOR

Routine Physical Therapy Exercise

Other: Routine Physical Therapy Exercises

Interventions

Self-Management Program OTHER

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.

Group A

Routine Physical Therapy Exercises OTHER

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.

Group B

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 36253020 BACKGROUND

• 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.

  PMID: 32153009 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Danish Hassan, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: May 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)