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

NCT05738720 | Recruiting

• 1 other identifier: Homespirometry1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

copd exacerbation; pulmonary rehabilitation; spirometry; hospital admission

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (13)

• Pulmonary Function Test (PFT) with home spirometry for FVC (Forced Vital Capacity) value

  Baseline to one year

• Daily Saturation Monitoring

  Baseline to one year

• Symptom scoring

  Baseline to one year

• Peripheral muscle strength measurement

  Baseline to one year

• 6 minutes walking test

  Baseline to one year

Study Arms (2)

Homespirometer Group (HsGr)

EXPERIMENTAL

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.

Device: Teknikel Spirobank Home Type Respiratory Function Tester (Homespirometer); Other: Exercise Programme

Control Group (CGr)

ACTIVE COMPARATOR

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.

Other: Exercise Programme

Interventions

Teknikel Spirobank Home Type Respiratory Function Tester (Homespirometer) 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.

Homespirometer Group (HsGr)

Exercise Programme 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); Homespirometer Group (HsGr)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Having the ability to use a smart phone and spirometer after training

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

• Esra PEHLİVAN, Assoc. Prof.

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Erdoğan ÇETİNKAYA, Prof. Dr.

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

• Mustafa ÇÖRTÜK, Assoc. Prof.

  SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

  STUDY CHAIR

• Fulya Senem KARAAHMETOĞLU, M. Sc.

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Zeynep Betül ÖZCAN, M. Sc.

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Central Study Contacts

Erdoğan ÇETİNKAYA, Prof. Dr.

CONTACT

+90 216 777 90 00; erdogan.cetinkaya@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: Prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: February 22, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

TU (1)