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

April 11, 2025 updated by: Bilecik Seyh Edebali Universitesi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Gulhane Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
pulmonary rehabilitation exercise + standard protocol
Behavioral: pulmonary rehabilitation exercise
pulmonary rehabilitation exercise + standard protocol
No Intervention: Control group
standard protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spielberger State-Trait Anxiety Inventory (STAI-I and STAI-II)
Time Frame: 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.
At baseline (first visit) and at 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 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.
At baseline (first visit) and at 8 weeks
6 Minute Walk Test (6MWT) Distance
Time Frame: At baseline (first visit) and at 8 weeks
Distance walked (meters) in the 6-Minute Walk Test. Higher distance indicates better functional capacity.
At baseline (first visit) and at 8 weeks
Modified Borg Dyspnea Scale (MBS)
Time Frame: 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).
At baseline (first visit) and at 8 weeks
Pulmonary Function Tests (FEV1)
Time Frame: 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.
At baseline (first visit) and at 8 weeks
Oxygen Saturation (SpO2, %) at Rest
Time Frame: At baseline (first visit) and at 8 weeks
Oxygen saturation (%) will be measured using a pulse oximeter at rest. Higher values indicate better oxygenation.
At baseline (first visit) and at 8 weeks
Pulmonary Function Tests (FVC)
Time Frame: 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.
At baseline (first visit) and at 8 weeks
Pulmonary Function Tests (FEV1/FVC)
Time Frame: 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.
At baseline (first visit) and at 8 weeks
Pulmonary Function Tests (FEF25-75%)
Time Frame: 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.
At baseline (first visit) and at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bilecik Seyh Edebali Universitesi

Investigators

  • Study Director: SABAHAT COŞKUN, Doç.Dr., Bilecik Seyh Edebali University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

April 11, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bilecik12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be shared upon request, in accordance with ethical guidelines and with participant consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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