Effects of Walking and Home-Based Pulmonary Rehabilitation on Anxiety and Sleep Quality

NCT ID: NCT06862713

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-04-11

Brief Summary

Although pulmonary rehabilitation plays an important role in increasing exercise tolerance and reducing hospitalizations in patients with chronic obstructive pulmonary disease (COPD), adherence to treatment is often low. Therefore, home-based pulmonary rehabilitation (PR) programs stand out as an effective intervention to alleviate the physiological and psychological burden of COPD patients and improve their quality of life. Nursing should develop a holistic approach to addressing the physical and psychological needs of patients to enhance the effectiveness of these programs.

This study aims to evaluate the effects of an 8-week home-based PR program on cardiopulmonary parameters, respiratory function, anxiety levels, and sleep quality in COPD patients.

As a randomized controlled trial, COPD patients will be divided into experimental and control groups. Pre- and post-tests will include the 6-minute walking test (6 MWT), dyspnea score, oxygen saturation, respiratory function tests (FEV1, FVC, FEV1/FVC, FEF 25-75), anxiety (STAI-I and STAI-II), and sleep quality (PSQI). Post-tests will be collected after the eight-week intervention.

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease characterized by exposure to harmful agents, associated with increased chronic inflammatory response of the lung, causing shortness of breath and significant systemic effects. COPD symptoms include not only shortness of breath, chronic cough, and increased sputum production, but also decreased exercise tolerance.

Although there are various treatment options that can reduce COPD symptoms (smoking cessation, pharmacological treatment, vaccines, etc.), there is no treatment yet that can return lung functions to their pre-disease normal state. Therefore, pulmonary rehabilitation is an important scientifically based, safe, and effective non-pharmacological treatment option recommended in guidelines for COPD patients to maintain the patient's quality of life. The most important component of pulmonary rehabilitation in COPD is exercise training. Pulmonary rehabilitation has been shown to increase exercise tolerance in patients with COPD, reduce re-admissions to hospital, and improve health status. Home-based pulmonary rehabilitation stands out as an alternative model that can overcome these barriers and increase access and participation. Initial studies suggest that home-based PR is safe and may improve clinical outcomes. The effectiveness of pulmonary rehabilitation in COPD patients is directly related to the patient's compliance with the program.

Difficulties experienced due to COPD also negatively affect the psychosocial status of patients. Shortness of breath can trigger anxiety and panic attacks in COPD patients. Anxiety and depression can worsen the health status of COPD patients and cause increased morbidity. In a study was determined that exercise improves anxiety and depression symptoms in COPD patients and increases the quality of life of patients. In addition, patients often complain of chronic insomnia; nearly 50% of patients report difficulty falling asleep, staying asleep, or experiencing unrefreshing sleep. The fact that there is no study in our country on non-pharmacological methods (pulmonary rehabilitation and exercise) to improve both anxiety and sleep quality in COPD patients and that an individual-focused pulmonary rehabilitation training program has been designed reveals the importance of this study and its contribution to the literature. This study evaluates the effects of walking and home-based pulmonary rehabilitation programs on anxiety and sleep quality in COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

pulmonary rehabilitation exercise + standard protocol

Group Type: EXPERIMENTAL

pulmonary rehabilitation exercise

Intervention Type: BEHAVIORAL

pulmonary rehabilitation exercise + standard protocol

Control group

standard protocol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pulmonary rehabilitation exercise

pulmonary rehabilitation exercise + standard protocol

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Ability to speak and understand Turkish
• Baseline saturation > 85%
• Confirmed stage II or stage III COPD diagnosis according to GOLD guidelines
• No infection or COPD exacerbation in the last 3 months
• Not participating in a pulmonary rehabilitation program in the last 3 months
• Able to walk without assistance and lift weights up to 2 kg
• No history of serious and/or unstable heart disease, neuromuscular disease, orthopedic disease, or mental illness that may affect daily physical activities
• Agree to participate in the study and give written informed consent
• No communication problems

Exclusion Criteria

• Patients who require hospitalization after starting the study
• Patients receiving continuous oxygen therapy
• Patients with a history of pulmonary hypertension, malignancy, pulmonary thromboembolism, obstructive sleep apnea, unstable angina, or myocardial infarction
• Patients with a heart rate above 120/min

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bilecik Seyh Edebali Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SABAHAT COŞKUN, Doç.Dr.

Role: STUDY_DIRECTOR

Bilecik Şeyh Edebali Üniversity

Locations

Gulhane Education and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

Bilecik12

Identifier Type: -

Identifier Source: org_study_id