Education Impact on Rehabilitation of Hospitalized Patients with Chronic Obstructive Pulmonary Disease.

NCT06028711 | Completed

• 1 other identifier: URzeszow/2023/06/0034/W
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The planned research will enable the assessment of rehabilitation's effects using two pulmonary rehabilitation models: conventional and supplemented with an education program for patients hospitalized due to chronic obstructive pulmonary disease.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

pulmonary rehabilitation; COPD patients' education

Outcome Measures

Primary Outcomes (29)

• Dynamic lung capacities (spirometry)

  Measurements will be performed with certified spirometer and the parameters analyzed will be Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) measured in litres \[L\].

  First examination- before the start of the interventions

• Dynamic lung capacities (spirometry)

  Measurements will be performed with certified spirometer and the parameters analyzed will be Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) measured in litres \[L\].

  Second examination- at the end of the 14-day rehabilitation program

• Modified Tiffeneau-Pinelli index (spirometry)

  Measurement will be performed with certified spirometer and the parameter analyzed will be the ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC ratio) presented as a decimal fraction.

  First examination- before the start of the interventions

• Modified Tiffeneau-Pinelli index (spirometry)

  Measurement will be performed with certified spirometer and the parameter analyzed will be the ratio of Forced Expiratory Volume in 1 Second to Forced Vital Capacity (FEV1/FVC ratio) presented as a decimal fraction.

  Second examination- at the end of the 14-day rehabilitation program

• Oxygen saturation

  Measurements will be performed with pulse oximeter and the parameter analyzed will be oxygen saturation by pulse oximetry (SpO2, percentage of oxygen in patients' blood).

  First examination- before the start of the interventions

• Oxygen saturation

  Measurements will be performed with pulse oximeter and the parameter analyzed will be oxygen saturation by pulse oximetry (SpO2, percentage of oxygen in patients' blood).

  Second examination- at the end of the 14-day rehabilitation program

• Pulse rate

  Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.

  First examination- before the start of the interventions

• Pulse rate

  Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.

  Second examination- at the end of the 14-day rehabilitation program

• Acid-base balance

  The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).

  First examination- before the start of the interventions

• Acid-base balance

  The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).

  Second examination- at the end of the 14-day rehabilitation program

• Exercise tolerance assessed by 6-minute walking test (6MWT)

  The test will be performed in 20-meter long hospital corridor. The patient should walk the distance at his own rhythm and pace, using orthopedic aids (if necessary). The patient will be informed that they can stop the test at any time if they feel it is necessary. The distance traveled in meters in 6 minutes will be analyzed.

  First examination- before the start of the interventions

• Exercise tolerance assessed by 6-minute walking test (6MWT)

  The test will be performed in 20-meter long hospital corridor. The patient should walk the distance at his own rhythm and pace, using orthopedic aids (if necessary). The patient will be informed that they can stop the test at any time if they feel it is necessary. The distance traveled in meters in 6 minutes will be analyzed.

  Second examination- at the end of the 14-day rehabilitation program

• Physical performance assessment by Fullerton functional fitness test

  The test comprising muscle endurance, aerobic capacity, flexibility, agility, and balance assessment. The test consist of 6 activities: 1. Arm Curl Test (number of forearm flexions in 30 seconds); 2. Back Scratch (the distance between middle fingers); 3. 30 Second Chair Stand (number of standings in 30 seconds); 4. Chair Sit-and-Reach ( '+' if fingers can reach toes in sitting position, '-' if fingers cannot reach toes in sitting position); 5. 8 - Foot Up-and-Go (8-foot walking time); 6. 2-Minute Step-in-Place (the number of lifts of the right leg).

  First examination- before the start of the interventions

• Physical performance assessment by Fullerton functional fitness test

  The test comprising muscle endurance, aerobic capacity, flexibility, agility, and balance assessment. The test consist of 6 activities: 1. Arm Curl Test (number of forearm flexions in 30 seconds); 2. Back Scratch (the distance between middle fingers); 3. 30 Second Chair Stand (number of standings in 30 seconds); 4. Chair Sit-and-Reach ( '+' if fingers can reach toes in sitting position, '-' if fingers cannot reach toes in sitting position); 5. 8 - Foot Up-and-Go (8-foot walking time); 6. 2-Minute Step-in-Place (the number of lifts of the right leg).

  Second examination- at the end of the 14-day rehabilitation program

• Fatigue assessment using modified Borg scale

  Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).

  First examination- before the start of the interventions

• Fatigue assessment using modified Borg scale

  Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).

  Second examination- at the end of the 14-day rehabilitation program

• Fatigue assessment using modified Borg scale

  Fatigue will be examined during physical activity and the level of fatigue will be marked on a scale from 1 (no fatigue) to 10 (very very hard fatigue).

  Third examination - two months after discharge from the hospital (follow- up)

• Dyspnea assessment with Medical Research Council dyspnea scale

  Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).

  First examination- before the start of the interventions

• Dyspnea assessment with Medical Research Council dyspnea scale

  Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).

  Second examination- at the end of the 14-day rehabilitation program

• Dyspnea assessment with Medical Research Council dyspnea scale

  Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).

  Third examination - two months after discharge from the hospital (follow- up)

• Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)

  Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.

  First examination- before the start of the interventions

• Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)

  Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.

  Second examination- at the end of the 14-day rehabilitation program

• Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)

  Assessment of quality of life, health and other areas. The scale contains 26 items, divided into four domains: physical health (7 items), psychological health (6 items), social relations (3 items), and environmental health (8 items), as well overall quality of life and general health (2 items). Patients express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). The final score is transformed linearly to a 0-100-scale, where higher scores denote higher quality of life.

  Third examination - two months after discharge from the hospital (follow- up)

• Anxiety and depression assessment using HADS scale

  The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.

  First examination- before the start of the interventions

• Anxiety and depression assessment using HADS scale

  The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.

  Second examination- at the end of the 14-day rehabilitation program

• Anxiety and depression assessment using HADS scale

  The scale consists of 16 statements to which the respondent refers on a four-point scale. Eight statements are used to measure anxiety and depression, each of which is rated on a scale of 0 to 3 points. The cut-off threshold is 7 points for depression and 7 points for anxiety. The intensity of depressed mood and anxiety will be analyzed.

  Third examination - two months after discharge from the hospital (follow- up)

• Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale

  Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).

  First examination- before the start of the interventions

• Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale

  Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).

  Second examination- at the end of the 14-day rehabilitation program

• Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale

  Life independence test, i.e. ensuring the functioning of the household by a sick person based on his/her ability to cope in the external environment or with a complex activity such as using the telephone and ensuring the related opportunities. The ability of basic functioning in the environment will be analyzed and each of 8 items will be rate trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The final total score ranges from 8 (low functioning, dependent) to 24 (high function, independent).

  Third examination - two months after discharge from the hospital (follow- up)

Study Arms (2)

Education program and Pulmonary rehabilitation

EXPERIMENTAL

Conventional pulmonary rehabilitation coupled with original education program.

Other: Education program; Other: Pulmonary rehabilitation

Pulmonary rehabilitation

OTHER

Conventional pulmonary rehabilitation

Other: Pulmonary rehabilitation

Interventions

Education program OTHER

Patients in a study group will participate in daily education program using an original brochure containing information on the benefits of appropriately adapted physical activity, practical tips on airway clearance techniques or physical exercise, and risk factors for exacerbation of COPD.

Education program and Pulmonary rehabilitation

Pulmonary rehabilitation OTHER

The patients will participate in a 14-day rehabilitation program (Monday to Saturday). Treatments and therapies will be continued for a maximum of two hours daily. The program will be applied individually to each patient and include active and assisted exercises, effective cough exercises, pursed-lips breathing, positive expiratory pressure exercises, exercises to strengthen the diaphragm and intercostal muscles and cardiopulmonary exercises.

Education program and Pulmonary rehabilitation; Pulmonary rehabilitation

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed chronic obstructive pulmonary disease in the exacerbation phase
• Moderate stage (II) of the disease
• Independence in basic activities of daily living (above 86 points on the Barthel scale)
• Age 55 y.o. to 70 y.o.
• No additional respiratory support (e.a. cardiopulmonary bypass machine, ventilator)
• Informed, voluntary consent to participate in research.

You may not qualify if:

• Diagnosed chronic obstructive pulmonary disease in remission
• Stages I, III and IV of the disease - a forms with mild, severe, and very severe obstruction
• Hospitalization in the intensive care unit, current health condition precluding participation in the study
• Age under 55 y.o. and over 70 y.o.
• Cognitive deficits impairing the ability to understand and execute commands
• Concomitant oncological, neurological, orthopedic, and psychiatric diseases may affect the examined persons' circulatory and respiratory functions, functional efficiency, quality of life, and emotional state.
• Failure to complete a 14-day rehabilitation program
• Lack of informed, voluntary consent to participate in research.

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszów

Rzeszów, 35-959, Poland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Renata Borys, MSc

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

• Agnieszka Guzik, A/Prof.

  University of Rzeszow

  STUDY DIRECTOR

• Magdalena Kołodziej, PhD

  University of Rzeszow

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: random selection to two groups (study group and control group)

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 8, 2023
• Study Start: July 28, 2023
• Primary Completion: September 2, 2024
• Study Completion: October 7, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

PL (1)