Clinical trial NCT06862713: Effects of Walking and Home-Based Pulmonary Rehabilitation on Anxiety and Sleep Quality
Official title: Determination of the Effects of Walking and Home-Based Pulmonary Rehabilitation on Anxiety and Sleep Quality in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
pulmonary rehabilitation
exercise
anxiety
sleep quality
randomized controlled trial
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Population and Sample The study population will consist of patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) who visit the chest diseases outpatient clinic of a training and research hospital and meet the study criteria. In this study, the anxiety level in COPD patients is determined as the primary observational variable. A power analysis is planned to determine the sample size of the study. Before conducting the power analysis, the effect size will be estimated based on a similar study previously conducted in the literature. Based on this study, Type-1 error (α) = 0.05, power (1-β) = 0.90, and effect size calculated for the Student's t-test (d = 0.364) were determined. Based on these parameters, the minimum required sample size is expected to be 41 patients per group, with a total of 82 participants. However, considering potential losses during the study process, it is planned to include a total of 90 patients.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Spielberger State-Trait Anxiety Inventory (STAI-I and STAI-II)
timeFrame: At baseline (first visit) and at 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At baseline (first visit) and at 8 weeks
measure: 6 Minute Walk Test (6MWT) Distance
timeFrame: At baseline (first visit) and at 8 weeks
measure: Modified Borg Dyspnea Scale (MBS)
timeFrame: At baseline (first visit) and at 8 weeks
measure: Pulmonary Function Tests (FEV1)
timeFrame: At baseline (first visit) and at 8 weeks
measure: Oxygen Saturation (SpO2, %) at Rest
timeFrame: At baseline (first visit) and at 8 weeks
measure: Pulmonary Function Tests (FVC)
timeFrame: At baseline (first visit) and at 8 weeks
measure: Pulmonary Function Tests (FEV1/FVC)
timeFrame: At baseline (first visit) and at 8 weeks
measure: Pulmonary Function Tests (FEF25-75%)
timeFrame: At baseline (first visit) and at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Education and Research Hospital
Study officials:
affiliation: Bilecik Şeyh Edebali Üniversity
name: SABAHAT COŞKUN, Doç.Dr.
role: STUDY_DIRECTOR
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