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

COPD Exacerbation Clinical Trial

Official title:

The Effect of Close Follow-Up Home Based Pulmonary Rehabilitation on Exacerbation Frequency and Hospital Admission in Severe COPD Cases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738720
• Other study ID #: Homespirometry1
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: April 2024
• Source: Saglik Bilimleri Universitesi
• Contact: Erdogan ÇETINKAYA, Prof. Dr.
• Phone: +90 216 777 90 00
• Email: erdogan.cetinkaya[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• 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.

Other:
• 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 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.

Locations

Country	Name	City	State
Turkey	SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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