FrailityNCT07472530
Respiratory Exercises in Frail Elderly COPD Patients
A study testing breathing exercises in people with Fraility and COPD (Chronic Obstructive Pulmonary Disease), run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fraility, COPD (Chronic Obstructive Pulmonary Disease), Older Adults (65 Years and Older)
- What is being tested?
- breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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),
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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").
- Being tested
- breathing exercises
- Keywords
- COPD, frailty, pulmonary rehabilitation, dyspnea, older adults
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Frailty, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function Test (PFT)-FVC
Forced vital capacity (FVC) is measured in liters.
Measured: 8 WEEKS
Pulmonary Function Test (PFT)- FEV1
Forced inspiratory volume in 1 second (FEV1) is measured in liters.
Measured: 8 WEEKS
Pulmonary Function Test (PFT)- FEF25-75
Forced expiratory flow rate (FEF25-75) is measured in liters/second.
Measured: 8 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Aug 2023
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Gönen Şentürk, PhD, RN, Çankırı Karatekin University
- Investigators
- Serap KINDAP, MD, Study director, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472530
- Sponsor's protocol ID
- 20-06-2023/8
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiratory Exercises on Frailty and Dyspnea in Geriatric Patients With Chronic Obstructive Pulmonary Disease: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07472530
- Acronym / sponsor ID
- 20-06-2023/8
- Keywords
- COPD, frailty, pulmonary rehabilitation, dyspnea, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Group Performing Breathing Exercises | Experimental | Other: breathing exercisesSubsequently, 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breathing exercisesInitially, 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. | Other | Intervention Group Performing Breathing Exercises |
Primary outcome
Pulmonary Function Test (PFT)-FVC
Time frame: 8 WEEKS
Forced vital capacity (FVC) is measured in liters.
Pulmonary Function Test (PFT)- FEV1
Time frame: 8 WEEKS
Forced inspiratory volume in 1 second (FEV1) is measured in liters.
Pulmonary Function Test (PFT)- FEF25-75
Time frame: 8 WEEKS
Forced expiratory flow rate (FEF25-75) is measured in liters/second.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap KINDAP, MD study director
Çankırı Karatekin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breathing exercises in people with Fraility and COPD (Chronic Obstructive Pulmonary Disease), run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test (PFT)-FVC (time frame: 8 WEEKS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.