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

NCT06862713 | Completed

• 1 other identifier: Bilecik12
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; pulmonary rehabilitation; exercise; anxiety; sleep quality; randomized controlled trial

Outcome Measures

Primary Outcomes (9)

• Spielberger State-Trait Anxiety Inventory (STAI-I and STAI-II)

  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)

  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

  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)

  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)

  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

  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)

  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)

  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%)

  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

Study Arms (2)

Intervention group

EXPERIMENTAL

pulmonary rehabilitation exercise + standard protocol

Behavioral: pulmonary rehabilitation exercise

Control group

NO INTERVENTION

standard protocol

Interventions

pulmonary rehabilitation exercise BEHAVIORAL

pulmonary rehabilitation exercise + standard protocol

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Gulhane Education and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (13)

• Xu J, He S, Han Y, Pan J, Cao L. Effects of modified pulmonary rehabilitation on patients with moderate to severe chronic obstructive pulmonary disease: A randomized controlled trail. Int J Nurs Sci. 2017 Jun 27;4(3):219-224. doi: 10.1016/j.ijnss.2017.06.011. eCollection 2017 Jul 10.

  PMID: 31406744 BACKGROUND

• Zhang Y, Li G, Liu C, Guan J, Zhang Y, Shi Z. Comparing the efficacy of different types of exercise for the treatment and prevention of depression in youths: a systematic review and network meta-analysis. Front Psychiatry. 2023 Jun 2;14:1199510. doi: 10.3389/fpsyt.2023.1199510. eCollection 2023.

  PMID: 37333923 BACKGROUND

• Yang PY, Ho KH, Chen HC, Chien MY. Exercise training improves sleep quality in middle-aged and older adults with sleep problems: a systematic review. J Physiother. 2012;58(3):157-63. doi: 10.1016/S1836-9553(12)70106-6.

  PMID: 22884182 BACKGROUND

• Soler X, Diaz-Piedra C, Ries AL. Pulmonary rehabilitation improves sleep quality in chronic lung disease. COPD. 2013 Apr;10(2):156-63. doi: 10.3109/15412555.2012.729622. Epub 2013 Mar 20.

  PMID: 23514215 BACKGROUND

• Li M, An X, Wang Q, Ma J, Wang Y, Ma J. Effect of Hope Theory combined with active cycle of breathing techniques on pulmonary rehabilitation among COPD patients: A quasi-experiment study. Appl Nurs Res. 2024 Oct;79:151842. doi: 10.1016/j.apnr.2024.151842. Epub 2024 Aug 26.

  PMID: 39256012 BACKGROUND

• Li J, Lu Y, Li N, Li P, Su J, Wang Z, Wang T, Yang Z, Yang Y, Chen H, Xiao L, Duan H, Wu W, Liu X. Muscle metabolomics analysis reveals potential biomarkers of exercise-dependent improvement of the diaphragm function in chronic obstructive pulmonary disease. Int J Mol Med. 2020 Jun;45(6):1644-1660. doi: 10.3892/ijmm.2020.4537. Epub 2020 Mar 12.

  PMID: 32186768 BACKGROUND

• Cox NS, Pepin V, Burge AT, Hill CJ, Lee AL, Bondarenko J, Moore R, Nicolson C, Lahham A, Parwanta Z, McDonald CF, Holland AE. Pulmonary Rehabilitation does not Improve Objective Measures of Sleep Quality in People with Chronic Obstructive Pulmonary Disease. COPD. 2019 Feb;16(1):25-29. doi: 10.1080/15412555.2019.1567701. Epub 2019 Mar 19.

  PMID: 30884984 BACKGROUND

• Higginson R, Parry A. Managing chronic obstructive pulmonary disease in the community setting. Br J Community Nurs. 2018 Jan 2;23(1):6-12. doi: 10.12968/bjcn.2018.23.1.6.

  PMID: 29281912 BACKGROUND

• Bains D, Chahal A, Shaphe MA, Kashoo FZ, Ali T, Alghadir AH, Khan M. Effects of Muscle Energy Technique and Joint Manipulation on Pulmonary Functions, Mobility, Disease Exacerbations, and Health-Related Quality of Life in Chronic Obstructive Pulmonary Disease Patients: A Quasiexperimental Study. Biomed Res Int. 2022 Jul 30;2022:5528724. doi: 10.1155/2022/5528724. eCollection 2022.

  PMID: 35941972 BACKGROUND

• Alnawwar MA, Alraddadi MI, Algethmi RA, Salem GA, Salem MA, Alharbi AA. The Effect of Physical Activity on Sleep Quality and Sleep Disorder: A Systematic Review. Cureus. 2023 Aug 16;15(8):e43595. doi: 10.7759/cureus.43595. eCollection 2023 Aug.

  PMID: 37719583 BACKGROUND

• Aiello M, Frizzelli A, Pisi R, Accogli R, Marchese A, Carlacci F, Bondarenko O, Tzani P, Chetta A. Effects of Daily Physical Activity on Exercise Capacity in Chronic Obstructive Pulmonary Disease. Medicina (Kaunas). 2024 Jun 21;60(7):1026. doi: 10.3390/medicina60071026.

  PMID: 39064455 BACKGROUND

• Adeloye D, Agarwal D, Barnes PJ, Bonay M, van Boven JF, Bryant J, Caramori G, Dockrell D, D'Urzo A, Ekstrom M, Erhabor G, Esteban C, Greene CM, Hurst J, Juvekar S, Khoo EM, Ko FW, Lipworth B, Lopez-Campos JL, Maddocks M, Mannino DM, Martinez FJ, Martinez-Garcia MA, McNamara RJ, Miravitlles M, Pinnock H, Pooler A, Quint JK, Schwarz P, Slavich GM, Song P, Tai A, Watz H, Wedzicha JA, Williams MC, Campbell H, Sheikh A, Rudan I. Research priorities to address the global burden of chronic obstructive pulmonary disease (COPD) in the next decade. J Glob Health. 2021 Oct 9;11:15003. doi: 10.7189/jogh.11.15003. eCollection 2021.

  PMID: 34737870 BACKGROUND

• Coskun S, Simsek NY, Arslan Y. Effects of Home-Based Pulmonary Rehabilitation on Walking, Anxiety and Sleep in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Int J Nurs Pract. 2025 Dec;31(6):e70085. doi: 10.1111/ijn.70085.

  PMID: 41351250 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• SABAHAT COŞKUN, Doç.Dr.

  Bilecik Şeyh Edebali Üniversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 6, 2025
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 11, 2025
• Last Updated: April 15, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)