Respiratory Exercises in Frail Elderly COPD Patients

The Effect of Respiratory Exercises on Frailty and Dyspnea in Geriatric Patients With Chronic Obstructive Pulmonary Disease: A Single-Blind Randomized Controlled Trial

Purpose: This study evaluated the impact of a structured intervention on frailty, lung function, physical capacity, and dyspnea in elderly COPD patients. COPD, common in older adults, often coexists with frailty, which worsens health outcomes. While pulmonary rehabilitation improves function, its effect on frailty remains unclear. Procedures: A total of 66 patients with a confirmed diagnosis of COPD were randomly allocated into two equal groups: an intervention group (n=33) and a control group (n=33). Participants in the intervention group completed a six-week pulmonary rehabilitation program. Both baseline and post-intervention evaluations comprised spirometric measurements (FVC, FEV1, FEV1/FVC ratio, FEF25-75, and PEF), the Edmonton Frailty Scale (EFS), the six-minute walk test (6MWT), oxygen saturation levels, and assessments of dyspnea severity. Results: Significant improvements were observed in the intervention group in FVC, FEV1, FEV1/FVC, and PEF (p<0.05). Total EFS scores and subdimensions such as mood, general health, and cognitive status also improved significantly (p<0.05). Additionally, the intervention group showed increased 6MWT distance, higher oxygen saturation, and reduced dyspnea scores post-intervention (p<0.05), with minimal changes in the control group. Conclusion: The findings suggest that pulmonary rehabilitation not only enhances pulmonary function and exercise capacity but also reduces frailty severity in elderly COPD patients. Integrating frailty-focused strategies into routine COPD management may improve outcomes and quality of life in this population.

Study Overview

• Status: Completed
• Conditions: COPD (Chronic Obstructive Pulmonary Disease); Fraility; Older Adults (65 Years and Older)
• Intervention / Treatment: Other: breathing exercises

Detailed Description

This prospective, single-blind, randomized controlled study was conducted between August 2023 and October 2023. A total of 70 patients who presented to the Chest Diseases Outpatient Clinic of Çerkeş State Hospital were enrolled.

T Following a one-month baseline assessment period, 32 patients who did not meet the inclusion criteria were excluded. Stratified randomization was employed to ensure equal assignment to groups based on age, sex, and COPD stage. Group allocations were determined using a computer-based program (random.org), randomly assigning 35 patients to the intervention group and 35 to the control group. Patients were blinded to their group assignments.

Initially, pre-test data were collected from both the intervention and control groups using the measurement instruments prior to the commencement of the exercise program. Subsequently, the intervention group underwent an eight-week exercise program using an incentive spirometer (Triflow) provided by the researchers. Patients were each given the same brand and model of Triflow device (manufactured in Turkey). Practical training on the use of the Triflow was provided, and visual materials prepared by the researcher were given to the patients. Exercise training was administered to the patients in the Chest Diseases Outpatient Clinic by the second author. Patients were instructed to perform the exercise hourly, 10 times per repetition, after waking up at home. The breathing exercise program was evaluated weekly via telephone calls with the patients. No changes were made to the patients' inhaler treatments during the study period.

During the study, one patient in the intervention group withdrew due to death, and another due to the initiation of treatment for pneumonia. A total of 33 patients completed the 8-week exercise program. No exercise regimen was applied to the control group; however, they were contacted regularly each week to inquire about any changes in their health status. Two patients in the control group were lost to follow-up, and therefore their post-test data could not be collected. At the conclusion of the exercise program, the measurement instruments were re-administered to 33 patients in the intervention group and 33 patients in the control group.Data Collection Instruments Data for the research were collected using the "Personal and Medical Characteristics Information Form" developed based on a literature review , along with the Six-Minute Walk Test , Modified Borg Dyspnea Scale , Pulmonary Function Test , and the Edmonton Frailty Scale.

Statistical analyses were carried out using IBM SPSS Statistics version 26. Descriptive data were summarized by calculating means, standard deviations, frequencies, and percentages. The assumptions of normality were assessed through skewness and kurtosis values, with acceptable ranges set at ±1.5 to confirm normal distribution. To assess differences between the intervention and control groups before and after treatment, Independent Samples t-tests were employed. Changes within groups from pre- to post-intervention were evaluated using Paired Samples t-tests. Categorical data comparisons were conducted with Chi-square and Fisher's Exact tests, where appropriate. Statistical significance was set at p < 0.05 for all analyses. Furthermore, A power analysis was conducted using the G*Power 3.1.9.7 software package. Based on the study results, the effect size was calculated as 1.23. Accordingly, with a sample size of 66 participants (33 in the intervention group and 33 in the control group), the study achieved a statistical power of 99.84% at a significance level of α = 0.05.

Ethical principles The authors affirm that all human subject experiments were performed in compliance with the Declaration of Helsinki, and that informed consent was obtained from all participants prior to the procedures. The study was approved by the "This area has been blinded" Ethics Committee (Number: "This area has been blinded"., Date: "This area has been blinded").

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Merkez
    • Çankırı, Merkez, Turkey (Türkiye), 18100
      • Çerkeş State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• a diagnosis of COPD for at least one year prior to participation,
• age 65 years or older,
• normal thoracic and vertebral spine and lower extremities,
• a score of 5 or higher on the Edmonton Frailty Scale,
• no participation in any pulmonary rehabilitation or exercise program within the last year

Exclusion Criteria:

• a history of myocardial infarction within the last 3 months,
• a history of angina pectoris or cerebrovascular event within the last month,
• uncontrolled arrhythmia,
• heart rate >120 beats/min,
• uncontrolled hypertension (BP >180/100 mmHg),
• advanced heart failure (Stage 3/Stage 4),
• severe anemia (Hb <7 g/dL),
• active or chronic infection (COPD exacerbation, Tuberculosis, Osteomyelitis, Rheumatoid Arthritis),
• resting or exertional dyspnea, exertional angina,
• increased cough and sputum complaints within the last week,
• hospitalization within the last month,
• blood transfusion within the last month
• the presence of physical or mental health problems that would impede communication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group Performing Breathing Exercises; Subsequently, the intervention group underwent an eight-week exercise program using an incentive spirometer (Triflow) provided by the researchers. Patients were each given the same brand and model of Triflow device (manufactured in Turkey). Practical training on the use of the Triflow was provided, and visual materials prepared by the researcher were given to the patients. Exercise training was administered to the patients in the Chest Diseases Outpatient Clinic by the second author. Patients were instructed to perform the exercise hourly, 10 times per repetition, after waking up at home. The breathing exercise program was evaluated weekly via telephone calls with the patients. No changes were made to the patients' inhaler treatments during the study period.	Other: breathing exercises; Initially, pre-test data were collected from both the intervention and control groups using the measurement instruments prior to the commencement of the exercise program. Subsequently, the intervention group underwent an eight-week exercise program using an incentive spirometer (Triflow) provided by the researchers. Patients were each given the same brand and model of Triflow device (manufactured in Turkey). Practical training on the use of the Triflow was provided, and visual materials prepared by the researcher were given to the patients. Exercise training was administered to the patients in the Chest Diseases Outpatient Clinic by the second author. Patients were instructed to perform the exercise hourly, 10 times per repetition, after waking up at home [14]. The breathing exercise program was evaluated weekly via telephone calls with the patients. No changes were made to the patients' inhaler treatments during the study period.
No Intervention: Control Group without Breathing Exercises; No exercise regimen was applied to the control group; however, they were contacted regularly each week to inquire about any changes in their health status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Function Test (PFT)-FVC	Forced vital capacity (FVC) is measured in liters.	8 WEEKS
Pulmonary Function Test (PFT)- FEV1	Forced inspiratory volume in 1 second (FEV1) is measured in liters.	8 WEEKS
Pulmonary Function Test (PFT)- FEF25-75	Forced expiratory flow rate (FEF25-75) is measured in liters/second.	8 WEEKS

Collaborators and Investigators

• Sponsor: Çankırı Karatekin University
• Investigators: Study Director: Serap KINDAP, MD, Çankırı Karatekin University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: older adults; COPD; frailty; pulmonary rehabilitation; dyspnea
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Pulmonary Disease, Chronic Obstructive; Dyspnea; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Breathing Exercises
• Other Study ID Numbers: 20-06-2023/8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No