Respiratory Exercises in Frail Elderly COPD Patients

NCT07472530 | Completed

• 1 other identifier: 20-06-2023/8
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fraility; COPD (Chronic Obstructive Pulmonary Disease); Older Adults (65 Years and Older)

Keywords

COPD; frailty; pulmonary rehabilitation; dyspnea; older adults

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention Group Performing Breathing Exercises

EXPERIMENTAL

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

Control Group without Breathing Exercises

NO INTERVENTION

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.

Interventions

breathing exercises OTHER

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.

Intervention Group Performing Breathing Exercises

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Çerkeş State Hospital

Çankırı, Merkez, 18100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Frailty; Dyspnea

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Serap KINDAP, MD

  Çankırı Karatekin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Prof. Dr.

Model Details: Study Design and Setting 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. The inclusion criteria were as follows: 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, and no participation in any pulmonary rehabilitation or exercise program within the last year \[11\]. Exclusion criteria comprised: 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, O

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: March 16, 2026
• Study Start: August 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2023
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)