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Effect of Home Based Pulmonary Rehabilitation on Exacerbation and Hospital Admission in Severe COPD

Primary Purpose

COPD Exacerbation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Teknikel Spirobank Home Type Respiratory Function Tester (Homespirometer)
Exercise Programme
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring copd exacerbation, pulmonary rehabilitation, spirometry, hospital admission

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Homespirometer Group (HsGr)

Control Group (CGr)

Arm Description

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 their illness twice a week on days without exercise. The evaluations made after 2 tests. They will be sent to the researchers via the device.andthe video containing the exercises after the first training will be sent to them via whatsapp for the exercise compliance of the patients. In the first exercise week, the first 2 exercise sessions will be done one-on-one via video call, and the exercises will be done correctly.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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".
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.
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.
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.
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.

Full Information

First Posted
January 15, 2023
Last Updated
May 12, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05738720
Brief Title
Effect of Home Based Pulmonary Rehabilitation on Exacerbation and Hospital Admission in Severe COPD
Official Title
The Effect of Close Follow-Up Home Based Pulmonary Rehabilitation on Exacerbation Frequency and Hospital Admission in Severe COPD Cases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
September 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 hospital for control and evaluated at baseline, 3rd, 6th and 12th months. Evaluations include assessments such as exercise capacity measurement, muscle strength measurement, disease attack frequency, symptom scoring.
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 requires an active collaboration between the patient, family, and the Pulmonary Rehabilitation team. Due to the complex nature of respiratory diseases, many disciplines should be involved in the maintenance of treatment. Pulmonary rehabilitation is a useful treatment component in almost all chronic respiratory patients, especially COPD (Chronic obstructive pulmonary disease). There are studies showing that it reduces the number of attacks and the frequency of hospitalization even in COPD patients with frequent attacks. As pulmonary rehabilitation methods; It is possible to see that there are many types such as supervised exercise programs in the hospital, telephone monitoring or home programs.In-hospital supervised programs are time-consuming and costly applications. This situation causes an increase in the tendency towards applications without direct supervision and increases the need for studies on the effectiveness and benefits of these applications. The use of home-type spirometers are practical devices that provide close monitoring of respiratory functions and enable the detection of disease symptoms in a short time. The use of these devices has increased especially during the pandemic period. In a study conducted with asthma patients, it was reported that early diagnosis and intervention is possible in cases with self-monitoring by mobile spirometry. In another study, in which e-monitoring of cases with duchenne muscular dystrophy (DMD) was performed with a spirometer device during the covid 19 pandemic, the importance of regular spirometric follow-ups of DMD cases as a part of their daily routine and making it a part of health care services was emphasized. In our study, advanced stage COPD cases constitute the case group. The exacerbation and hospital admission rates are extremely high in these patients. There are also transfer problems to the hospital due to existing physical limitations. With the planned study, close follow-up of the patients with the help of home-type spirometry will be carried out over a 1-year period, and a pulmonary rehabilitation exercise program will be applied in this process. The effect of the applied follow-up and exercise program on disease exacerbation and hospital admission rates will be examined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
Keywords
copd exacerbation, pulmonary rehabilitation, spirometry, hospital admission

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Homespirometer Group (HsGr)
Arm Type
Experimental
Arm Description
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 their illness twice a week on days without exercise. The evaluations made after 2 tests. They will be sent to the researchers via the device.andthe video containing the exercises after the first training will be sent to them via whatsapp for the exercise compliance of the patients. In the first exercise week, the first 2 exercise sessions will be done one-on-one via video call, and the exercises will be done correctly.
Arm Title
Control Group (CGr)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Teknikel Spirobank Home Type Respiratory Function Tester (Homespirometer)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Programme
Intervention Description
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 breaks will be given when necessary. The exercises will be performed with a medium-hardness therabband. Exercises will be given for the upper extremity and lower extremity, and the patients will be asked to do 10 repetitions. Gait training: In line with the data obtained from the 6-minute walking test, gait training will be given on flat ground at 60% workload (land-based walking). Patients will be allowed to walk on flat ground at 60% workload, at a time calculated based on the results of the 6-minute walk test.
Primary Outcome Measure Information:
Title
Number of exacerbations follow-up
Description
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.
Time Frame
1 month after the evaluation
Title
Number of hospital admissions
Description
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.
Time Frame
1 month after the evaluation
Title
Number of exacerbations follow-up
Description
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.
Time Frame
3 month after the first evaluation
Title
Number of exacerbations follow-up
Description
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.
Time Frame
6 month after the first evaluation
Title
Number of exacerbations follow-up
Description
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.
Time Frame
12 month after the first evaluation
Title
Number of hospital admissions
Description
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.
Time Frame
3 month after the first evaluation
Title
Number of hospital admissions
Description
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.
Time Frame
6 month after the first evaluation
Title
Number of hospital admissions
Description
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.
Time Frame
12 month after the first evaluation
Secondary Outcome Measure Information:
Title
Pulmonary Function Test (PFT) with home spirometry for FVC (Forced Vital Capacity) value
Description
Pulmonary function test will be performed with Teknikel Spirobank home type pulmonary. The FVC value will be calculated.
Time Frame
Baseline to one year
Title
Daily Saturation Monitoring
Description
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.
Time Frame
Baseline to one year
Title
Symptom scoring
Description
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.
Time Frame
Baseline to one year
Title
Peripheral muscle strength measurement
Description
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.
Time Frame
Baseline to one year
Title
6 minutes walking test
Description
It will be carried out in the 30 meter corridor in accordance with ATS (American Thoracic Society) and ERS (European Respiratory Society) guidelines.
Time Frame
Baseline to one year
Title
Modified medical Council Dyspnea score
Description
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.
Time Frame
Baseline to one year
Title
Determination of quality of life
Description
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.
Time Frame
Baseline to one year
Title
Psychological status assessment
Description
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.
Time Frame
Baseline to one year
Title
Cognitive status assessment
Description
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".
Time Frame
Baseline to one year
Title
Physical activity level
Description
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.
Time Frame
Baseline to one year
Title
Heart Rate Monitoring
Description
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.
Time Frame
Baseline to one year
Title
Pulmonary Function Test (PFT) with home spirometry for FEV1 (Forced Expiratory Volume First Second) value
Description
Pulmonary function test will be performed with Teknikel Spirobank home type pulmonary. The FEV1 value will be calculated.
Time Frame
Baseline to one year
Title
Pulmonary Function Test (PFT) with home spirometry for FEV1/FVC (Tiffeneau indeksi) value
Description
Pulmonary function test will be performed with Teknikel Spirobank home type pulmonary. The FEV1/FVC value will be calculated.
Time Frame
Baseline to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erdoğan ÇETİNKAYA, Prof. Dr.
Phone
+90 216 777 90 00
Email
erdogan.cetinkaya@sbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra PEHLİVAN, Assoc. Prof.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erdoğan ÇETİNKAYA, Prof. Dr.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mustafa ÇÖRTÜK, Assoc. Prof.
Organizational Affiliation
SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fulya Senem KARAAHMETOĞLU, M. Sc.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zeynep Betül ÖZCAN, M. Sc.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
Facility Information:
Facility Name
SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erdoğan ÇETİNKAYA, Prof. Dr.
Phone
0212 409 02 00
Email
erdogan.cetinkaya@sbu.edu.tr

12. IPD Sharing Statement

Learn more about this trial

Effect of Home Based Pulmonary Rehabilitation on Exacerbation and Hospital Admission in Severe COPD

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