Clinical trial NCT05738720: 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
Overall status: RECRUITING
Phase: NA
Conditions: COPD Exacerbation
Keywords: copd exacerbation
pulmonary rehabilitation
spirometry
hospital admission
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of exacerbations follow-up
timeFrame: 1 month after the evaluation
measure: Number of hospital admissions
timeFrame: 1 month after the evaluation
measure: Number of exacerbations follow-up
timeFrame: 3 month after the first evaluation
measure: Number of exacerbations follow-up
timeFrame: 6 month after the first evaluation
measure: Number of exacerbations follow-up
timeFrame: 12 month after the first evaluation
measure: Number of hospital admissions
timeFrame: 3 month after the first evaluation
measure: Number of hospital admissions
timeFrame: 6 month after the first evaluation
measure: Number of hospital admissions
timeFrame: 12 month after the first evaluation
Secondary outcomes:
measure: Pulmonary Function Test (PFT) with home spirometry for FVC (Forced Vital Capacity) value
timeFrame: Baseline to one year
measure: Daily Saturation Monitoring
timeFrame: Baseline to one year
measure: Symptom scoring
timeFrame: Baseline to one year
measure: Peripheral muscle strength measurement
timeFrame: Baseline to one year
measure: 6 minutes walking test
timeFrame: Baseline to one year
measure: Modified medical Council Dyspnea score
timeFrame: Baseline to one year
measure: Determination of quality of life
timeFrame: Baseline to one year
measure: Psychological status assessment
timeFrame: Baseline to one year
measure: Cognitive status assessment
timeFrame: Baseline to one year
measure: Physical activity level
timeFrame: Baseline to one year
measure: Heart Rate Monitoring
timeFrame: Baseline to one year
measure: Pulmonary Function Test (PFT) with home spirometry for FEV1 (Forced Expiratory Volume First Second) value
timeFrame: Baseline to one year
measure: Pulmonary Function Test (PFT) with home spirometry for FEV1/FVC (Tiffeneau indeksi) value
timeFrame: Baseline to one year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Esra PEHLİVAN, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Erdoğan ÇETİNKAYA, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
name: Mustafa ÇÖRTÜK, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Fulya Senem KARAAHMETOĞLU, M. Sc.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Zeynep Betül ÖZCAN, M. Sc.
role: STUDY_CHAIR
References: