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

NCT ID: NCT05738720

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-12-20

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.

Conditions

COPD Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Homespirometer 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 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.

Group Type: EXPERIMENTAL

Teknikel Spirobank Home Type Respiratory Function Tester (Homespirometer)

Intervention Type: DEVICE

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

Intervention Type: OTHER

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.

Control 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.

Group Type: ACTIVE_COMPARATOR

Exercise Programme

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

ESRA PEHLIVAN

Assoc. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esra PEHLİVAN, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Erdoğan ÇETİNKAYA, Prof. Dr.

Role: STUDY_DIRECTOR

Saglik Bilimleri Universitesi

Mustafa ÇÖRTÜK, Assoc. Prof.

Role: STUDY_CHAIR

SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Fulya Senem KARAAHMETOĞLU, M. Sc.

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Zeynep Betül ÖZCAN, M. Sc.

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Locations

SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Erdoğan ÇETİNKAYA, Prof. Dr.

Role: CONTACT

erdogan.cetinkaya@sbu.edu.tr

+90 216 777 90 00

Facility Contacts

Erdoğan ÇETİNKAYA, Prof. Dr.

Role: primary

erdogan.cetinkaya@sbu.edu.tr

0212 409 02 00

Other Identifiers

Homespirometry1

Identifier Type: -

Identifier Source: org_study_id