The Impact of Education on the Rehabilitation of Patients Hospitalized Due to Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Dynamic lung capacities (spirometry)
研究概览
简要总结
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.
详细描述
The planned group size is 100 patients diagnosed with chronic obstructive pulmonary disease (COPD) and hospitalized due to exacerbation. The given population was calculated based on the sampling calculator, considering the following parameters: fraction size, confidence level, and maximum error.
Eligible patients will be randomly divided into two groups: a study group (50 patients) undergoing pulmonary rehabilitation supplemented with an education program and a control group (50 patients) undergoing conventional pulmonary rehabilitation.
Patients of both groups will be included 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, including 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. Patients from the study group will additionally undergo daily education 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.
The test will be performed three times: before the start of rehabilitation, after completing the rehabilitation program, and the follow-up after two months from the end of hospitalization to assess long-term effects. After the end of the study, people from the control group will also undergo education.
The patients' condition and the rehabilitation effects will be assessed using the following measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Dynamic lung capacities (spirometry)
时间窗: Second examination- at the end of the 14-day rehabilitation program
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 \[L\].
Oxygen saturation
时间窗: Second examination- at the end of the 14-day rehabilitation program
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).
Modified Tiffeneau-Pinelli index (spirometry)
时间窗: Second examination- at the end of the 14-day rehabilitation program
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.
Acid-base balance
时间窗: Second examination- at the end of the 14-day rehabilitation program
The gasometry results will be taken from patients' medical documentation. The parameters analyzed will be oxygen pressure (pO2) and carbon dioxide pressure (pCO2).
Pulse rate
时间窗: Second examination- at the end of the 14-day rehabilitation program
Measurements will be performed with pulse oximeter and the parameter analyzed will be the number of patients' heart beats per minute.
Fatigue assessment using modified Borg scale
时间窗: Third examination - two months after discharge from the hospital (follow- up)
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).
Exercise tolerance assessed by 6-minute walking test (6MWT)
时间窗: Second examination- at the end of the 14-day rehabilitation program
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.
Quality of life assessment using World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
时间窗: Third examination - two months after discharge from the hospital (follow- up)
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.
Anxiety and depression assessment using HADS scale
时间窗: Third examination - two months after discharge from the hospital (follow- up)
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.
Physical performance assessment by Fullerton functional fitness test
时间窗: Second examination- at the end of the 14-day rehabilitation program
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).
Dyspnea assessment with Medical Research Council dyspnea scale
时间窗: Third examination - two months after discharge from the hospital (follow- up)
Perceived breathlessness degree will be marked on a scale 0 (no breathlessness) to 4 (breathlessness at rest).
Activities of daily living assesment using Lawton Instrumental Activities of Daily Living (IADL) Scale
时间窗: Third examination - two months after discharge from the hospital (follow- up)
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).
次要结局
未报告次要终点
研究者
Renata Borys
Principal Investigator
University of Rzeszow