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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT06862713
• Lead Sponsor: Bilecik Seyh Edebali Universitesi

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.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-04-01
• Study First Submitted: 2025-02-11
• Primary Completion: 2025-03-01
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-06
• Study Completion: 2025-04-11
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Spielberger State-Trait Anxiety Inventory (STAI-I and STAI-II)	At baseline (first visit) and at 8 weeks	The Spielberger State-Trait Anxiety Inventory (STAI-I and STAI-II), developed by Spielberger et al. (1970) and adapted to Turkish by Öner and Le Compte (1995), assesses anxiety levels in individuals aged 14 and above. The inventory consists of two subscales, each with 20 items rated on a 4-point Likert scale.; STAI-I (State Anxiety): Measures how an individual feels at a specific moment under certain conditions (1 = Not at all, 4 = Completely). STAI-II (Trait Anxiety): Evaluates the individual's general anxiety tendency in the absence of external threats (1 = Almost never, 4 = Almost always). Each subscale includes reverse-scored items (10 in STAI-I, 7 in STAI-II). Total scores range from 20 to 80, with higher scores indicating greater anxiety. The average scores typically range between 36 and 41.
Pittsburgh Sleep Quality Index (PSQI)	At baseline (first visit) and at 8 weeks	The Pittsburgh Sleep Quality Index (PSQI), assesses sleep quality and habits over the past month. The scale consists of 19 self-reported items and 5 additional items answered by a bed partner or roommate (not included in scoring).; The PSQI includes seven components: Subjective sleep quality Sleep latency Sleep duration Habitual sleep efficiency Sleep disturbances Use of sleep medication Daytime dysfunction Each component is scored between 0 (best) and 3 (worst), with a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and a total score above 5 is considered indicative of poor sleep quality. The PSQI does not diagnose sleep disorders but serves as a useful tool for evaluating overall sleep quality. The reliability analysis reported a Cronbach's α of 0.80.
Pulmonary Function Tests (FEV1/FVC)	At baseline (first visit) and at 8 weeks	The FEV1/FVC ratio is the ratio of the patient's forced expiratory volume in the first 1 second to the total mandatory vital capacity. FEV1/FVC ratio will be measured using spirometry. Unit of Measure: percent (%), Higher FEV1/FVC percentile is associated with better respiratory function.
6 Minute Walk Test (6MWT) Distance	At baseline (first visit) and at 8 weeks	Distance walked (meters) in the 6-Minute Walk Test. Higher distance indicates better functional capacity.
Modified Borg Dyspnea Scale (MBS)	At baseline (first visit) and at 8 weeks	The Modified Borg Scale (MBS) assess perceived exertion during physical activity. It is one of the most reliable scales for evaluating dyspnea severity during both rest and exertion.The MBS consists of 10 items, each describing increasing levels of dyspnea intensity. It is simple to use and has been shown to correlate with pulmonary function tests. Dyspnea is assessed using the MBS at the end of the 6-Minute Walk Test (6MWT).; The scale ranges from 0 (no breathlessness) to 10 (maximum breathlessness).
Pulmonary Function Tests (FEV1)	At baseline (first visit) and at 8 weeks	Forced expiratory volume in 1 second (FEV1), Unit of Measure: percent (%), Higher FEV1 percentile is associated with better respiratory function.
Oxygen Saturation (SpO2, %) at Rest	At baseline (first visit) and at 8 weeks	Oxygen saturation (%) will be measured using a pulse oximeter at rest. Higher values indicate better oxygenation.
Pulmonary Function Tests (FVC)	At baseline (first visit) and at 8 weeks	Forced vital capacity (FVC), Unit of Measure: percent (%), Higher FVC percentile is associated with better respiratory function.
Pulmonary Function Tests (FEF25-75%)	At baseline (first visit) and at 8 weeks	Forced expiratory flow rate (FEF25-75%) represents the midairway flow rate between 25% and 75% of forced expiration. Unit of Measure: percent (%).An increase in FEF 25-75% may indicate improvement in small airways and a decrease in obstructive airway diseases.

Trial Locations

Locations (1)

Gulhane Education and Research Hospital; 🇹🇷 Ankara, Turkey