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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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 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.
SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
RECRUITINGNumber 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 month after the first evaluation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to one year
Determination of quality of life
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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
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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to one year