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Clinical Trial NCT05738720 for COPD Exacerbation is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Saglik Bilimleri UniversitesiEffect of Home Based Pulmonary Rehabilitation on Exacerbation and Hospital Admission in Severe COPD 24 Home-Based Randomized Exercise-Based
Clinical Trial NCT05738720 is an interventional study for COPD Exacerbation that is recruiting. It started on 1 February 2023 with plans to enroll 24 participants. Led by Saglik Bilimleri Universitesi, it is expected to complete by 20 December 2026. The latest data from ClinicalTrials.gov was last updated on 1 May 2025.
Brief Summary
The study is a randomized controlled trial. The cases will be divided into two groups as the Homespirometer group and the control group. Breathing exercises, aerobic exercise and peripheral muscle strengthening will be performed in both groups. A home-type spirometer will be given to the homespirometer group and it will be requested to send the spirometric measurement every week. The cases will be called to the hospi...Show More
Detailed Description
Pulmonary Rehabilitation (PR) is a comprehensive intervention designed to improve not only exercise, education and behavioral changes, but also the physical and psychological state of individuals, based on detailed patient evaluation and subsequent patient-specific therapies in individuals with chronic respiratory disease. It is integrated into the lifelong care and management of the chronic respiratory patient. It r...Show More
Official Title
The Effect of Close Follow-Up Home Based Pulmonary Rehabilitation on Exacerbation Frequency and Hospital Admission in Severe COPD Cases
Conditions
COPD ExacerbationOther Study IDs
- Homespirometry1
NCT ID Number
Start Date (Actual)
2023-02-01
Last Update Posted
2025-05-01
Completion Date (Estimated)
2026-12-20
Enrollment (Estimated)
24
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
copd exacerbation
pulmonary rehabilitation
spirometry
hospital admission
pulmonary rehabilitation
spirometry
hospital admission
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHomespirometer Group (HsGr) Patients will be taught to use the homespirometer device, download the phone application, use the application, use the video call feature, measure saturation and heart rate with the same device, and daily symptom scoring in the device's system.
Patients will be asked to perform pulmonary function tests with a spirometer device, measure saturation and heart rate, score symptoms, and write down any problems related to...Show More | Teknikel Spirobank Home Type Respiratory Function Tester (Homespirometer) Pulmonary Function Test (PFT): Pulmonary function test will be performed with a Teknikel Spirobank home pulmonary function test device. In the study group, the patient will make weekly measurements at home and send it to the physiotherapist. In the control group, evaluation will be made with the device only at the beginning and end of the treatment. Exercise Programme Exercise Program
* Breathing exercises: Chest, diaphragmatic breathing and lower basal breathing exercises will be performed with 10 repetitions.
* Resistance exercises: Strengthening exercises will be performed on the major muscle groups of the upper and lower extremities by using medium hardness therabant. During the exercises, the patient's fatigue and dyspnea levels will be questioned using the Borg scale, and b...Show More |
Active ComparatorControl Group (CGr) The same exercise training will be taught to the study group and the same exercise video will be sent to the patients via WhatsApp. The first 2 exercise sessions will be done one-on-one via video call (via whatsapp), and the exercises will be done correctly. Patients will be given an exercise diary and asked to take notes on their weekly exercises. | Exercise Programme Exercise Program
* Breathing exercises: Chest, diaphragmatic breathing and lower basal breathing exercises will be performed with 10 repetitions.
* Resistance exercises: Strengthening exercises will be performed on the major muscle groups of the upper and lower extremities by using medium hardness therabant. During the exercises, the patient's fatigue and dyspnea levels will be questioned using the Borg scale, and b...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of exacerbations follow-up | After the first evaluation, he will be questioned at the 1st month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device. | 1 month after the evaluation |
Number of hospital admissions | After the first evaluation, he will be questioned at the 1st month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device. | 1 month after the evaluation |
Number of exacerbations follow-up | After the first evaluation, he will be questioned at the 3rd month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device. | 3 month after the first evaluation |
Number of exacerbations follow-up | After the first evaluation, he will be questioned at the 6th month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device. | 6 month after the first evaluation |
Number of exacerbations follow-up | After the first evaluation, he will be questioned at the 12th month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device. | 12 month after the first evaluation |
Number of hospital admissions | After the first evaluation, he will be questioned at the 3rd month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device. | 3 month after the first evaluation |
Number of hospital admissions | After the first evaluation, he will be questioned at the 6th month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device. | 6 month after the first evaluation |
Number of hospital admissions | After the first evaluation, he will be questioned at the 12th month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device. | 12 month after the first evaluation |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pulmonary Function Test (PFT) with home spirometry for FVC (Forced Vital Capacity) value | Pulmonary function test will be performed with Teknikel Spirobank home type pulmonary. The FVC value will be calculated. | Baseline to one year |
Daily Saturation Monitoring | Saturation monitoring can be done in the PFT device. The patient will be asked to take measurements twice a week (on the specified days) and record them on the device. | Baseline to one year |
Symptom scoring | Questions about the symptomatic situation will be requested to be answered within the PFT device. The questions include questioning dyspnea and fatigue with a 3-point Likert scale. While 3 points define increased dyspnea or fatigue with 3 points, symptoms expected to decrease as they approach 0 points. | Baseline to one year |
Peripheral muscle strength measurement | The muscle groups to be tested are: (shoulder flexors, elbow flexors, hand grip, hip flexors, knee extensors and dorsi flexors. The test will be done by Lafayette brand digital muscle strength meter. | Baseline to one year |
6 minutes walking test | It will be carried out in the 30 meter corridor in accordance with ATS (American Thoracic Society) and ERS (European Respiratory Society) guidelines. | Baseline to one year |
Modified medical Council Dyspnea score | The scale is a score that measures the reflections of dyspnea degrees ranging from 0 to 4 on activities of daily living. While scoring, the patients were asked to mark the activity level that caused dyspnea in them. On this scale, 1 point defines the best condition in terms of dyspnea, and 5 points the worst. | Baseline to one year |
Determination of quality of life | The Saint George Respiratory Questionnaire (SGRQ) will be used. All of the patients will be answered the questions themselves and scores will be calculated using the score calculation algorithm (SGRQ manual version 2). The total score ranges from 0-100. A score of zero indicates normal and a score of 100 indicates maximum disability. | Baseline to one year |
Psychological status assessment | The Hospital Anxiety and Depression Scale will be used. By adding the subscale scores of the questionnaire, 0-21 points can be obtained from each of the Depression and Anxiety subscales. It is stated that 0-7 points for each subscale are in the normal range, 8-10 points suggest the presence of a mood disorder, and a score of 11 and above indicates possible mood disorder. | Baseline to one year |
Cognitive status assessment | The Montreal Cognitive Assessment (MOCA) questionnaire will be used. The highest score that can be obtained from the test is 30. A score of 21 and above is considered "normal". | Baseline to one year |
Physical activity level | The short form of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used. ollowing the IPAQ guidelines, the respondents will be categorized as engaged in vigorous physical activity, moderate physical activity, or low physical activity. MET-Minute (Metabolic Equivalent of Task-Minute) is calculated by multiplying the minute of activity with the MET score. When classifying populations categorically, there are three levels of physical activity identified - 'inactive', 'minimally active' and 'very active (physical activity that increases well-being)'. The 'very active' category falls on the higher threshold of activity. | Baseline to one year |
Heart Rate Monitoring | Heart rate monitoring can be done in the PFT device. The patient will be asked to take measurements twice a week (on the specified days) and record them on the device. | Baseline to one year |
Pulmonary Function Test (PFT) with home spirometry for FEV1 (Forced Expiratory Volume First Second) value | Pulmonary function test will be performed with Teknikel Spirobank home type pulmonary. The FEV1 value will be calculated. | Baseline to one year |
Pulmonary Function Test (PFT) with home spirometry for FEV1/FVC (Tiffeneau indeksi) value | Pulmonary function test will be performed with Teknikel Spirobank home type pulmonary. The FEV1/FVC value will be calculated. | Baseline to one year |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Being between the ages of 18-75
- Having a diagnosis of COPD stages C and D diagnosed according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) clinical diagnostic criteria
- Presence of dyspnea on exertion
- Stable clinical condition at the time of inclusion without infection or exacerbation in the previous 4 weeks
- Having the ability to use a smart phone and spirometer after training
- Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy \(˃ 3-4 L \min\).
- A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
- Participation in a pulmonary rehabilitation program within the past 12 months.
Saglik Bilimleri Universitesi141 active studies to exploreStudy Responsible Party
ESRA PEHLIVAN, Principal Investigator, Assoc. Prof. Dr., Saglik Bilimleri Universitesi
Study Central Contact
Contact: Erdoğan ÇETİNKAYA, Prof. Dr., +90 216 777 90 00, [email protected]
1 Study Locations in 1 Countries
SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey (Türkiye)
Erdoğan ÇETİNKAYA, Prof. Dr., Contact, 0212 409 02 00, [email protected]
Recruiting