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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSaglik Bilimleri Universitesi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Exercise Programme

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Homespirometer Group (HsGr)Experimental treatment 2 interventions
Group B: Control Group (CGr)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month after the evaluation
2

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.

Time frame
1 month after the evaluation
3

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.

Time frame
3 month after the first evaluation
4

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.

Time frame
6 month after the first evaluation

Secondary outcomes

1

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.

Time frame
Baseline to one year
2

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.

Time frame
Baseline to one year
3

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.

Time frame
Baseline to one year
4

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.

Time frame
Baseline to one year

Other outcomes

Sponsors and contacts

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