Effect of Home Based Pulmonary Rehabilitation on Exacerbation and Hospital Admission in Severe COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teknikel Spirobank Home Type Respiratory Function Tester (Homespirometer), Exercise Programme.
- Who it may be relevant to
- Registry conditions: COPD Exacerbation. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Close Follow-Up Home Based Pulmonary Rehabilitation on Exacerbation Frequency and Hospital Admission in Severe COPD Cases
Overview
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.
Interventions
- 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 mediu
Primary outcome measures
- Number of exacerbations follow-up [Time frame: 1 month after the evaluation]
- Number of hospital admissions [Time frame: 1 month after the evaluation]
- Number of exacerbations follow-up [Time frame: 3 month after the first evaluation]
- Number of exacerbations follow-up [Time frame: 6 month after the first evaluation]
- Number of exacerbations follow-up [Time frame: 12 month after the first evaluation]
- Number of hospital admissions [Time frame: 3 month after the first evaluation]
- Number of hospital admissions [Time frame: 6 month after the first evaluation]
- Number of hospital admissions [Time frame: 12 month after the first evaluation]
Secondary outcome measures (12)
- Pulmonary Function Test (PFT) with home spirometry for FVC (Forced Vital Capacity) value [Time frame: Baseline to one year]
- Daily Saturation Monitoring [Time frame: Baseline to one year]
- Symptom scoring [Time frame: Baseline to one year]
- Peripheral muscle strength measurement [Time frame: Baseline to one year]
- 6 minutes walking test [Time frame: Baseline to one year]
- Modified medical Council Dyspnea score [Time frame: Baseline to one year]
- Determination of quality of life [Time frame: Baseline to one year]
- Psychological status assessment [Time frame: Baseline to one year]
- Cognitive status assessment [Time frame: Baseline to one year]
- Physical activity level [Time frame: Baseline to one year]
- Heart Rate Monitoring [Time frame: Baseline to one year]
- Pulmonary Function Test (PFT) with home spirometry for FEV1 (Forced Expiratory Volume First Second) value [Time frame: Baseline to one year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital — Istanbul
Identifiers
NCT: NCT05738720 · Homespirometry1