Short, Medium and Long-term Effects of Pulmonary Rehabilitation in Dyspnea, Health Status, Anxiety and Depression Symptoms, Functional Status and Postural Control and Its Relationship With Morbimortality in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Morbidity
研究概览
简要总结
Background: The pulmonary rehabilitation effects on various outcomes of COPD are well known. However, they may be lost over time due to poor adherence to therapy with absence of regular exercise maintenance in long term, disease progression, comorbidities, falls incidence and higher exacerbations frequency. Currently, the main focus is to make the patient more active and ensure the benefits maintenance. However, few studies have been concerned with the aim of to investigate the long-term effect of this intervention and the relationship of the change promoted in important outcomes of the disease with its morbidity and mortality.
Design: Non-controlled clinical trial, prospective and longitudinal. Setting: Outpatient pulmonary rehabilitation program in Florianopolis, Brazil
Subjects: Patients with COPD (GOLD II-IV).
Interventions: Pulmonary rehabilitation program (PRP) based on physical training, conducted over 24 sessions supervised, three times a week, including aerobic training in treadmill and resistance training for upper and lower limbs.
Main measures: Before, post-PRP, 6 months post-PRP and 12 months post-PRP will be measured Spirometry or Total Body Plethysmography, Triaxial Accelerometry by Dynaport Activity Monitor, Glittre ADL-Test to evaluated functional capacity and functional performance, Six-Minute Walk Test distance on tracks of 20 and 30 meters, muscle oxygenation variables by NIRS PortaLite®, force platform NeuroCom® SMART Equitest®, Timed Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence, Falls Efficacy Scale - International - Brasil, London Chest Activity of Daily Living score, Modified Medical Research Council score, Saint George Respiratory Questionnaire score, COPD Assessment Test score and Hospital Anxiety and Depression Scale, Behavioural Regulation in Exercise Questionnaire-2, Basic Psychological Needs in Exercise Scale, General self-efficacy scale, COPD self-efficacy scale, Pulmonary Rehabilitation Adapted Index of Self-Efficacy. The death cases and numbers of exacerbations and hospitalizations will be measured by monthly phone calls after PRP.
详细描述
Assigned Interventions: Pulmonary rehabilitation program (PRP) will be conducted according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Physical training will be conducted over 24 sessions supervised, three times a week. The program will include aerobic training in treadmill (with 30 min load determined by the dyspnea sensation - 4 to 6 on the modified Borg scale) and resistance training for upper limbs with free weights or elastic bands (movements performed based on the proprioceptive neuromuscular facilitation diagonals, performed in two series, lasting two minutes each) and lower limbs (quadriceps and triceps sural) with free weights and/or in the bodybuilding station. All the muscle exercised and the breathing accessory muscles will be stretched for 30s each. Eleven 30-minute educational sessions will be delivered addressing topics related to disease self-management.
The death cases and numbers of exacerbations and hospitalizations will be measured by monthly phone calls after PRP.
Before PRP, post-PRP, 6 months post-PRP and 12 months post-PRP will be evaluated:
Pulmonary function test: Spirometry (EasyOne, NDD) or Total Body Plethysmography (Eric Jaeger, Germany) will be performed in accordance with ATS/ERS standards in order to provide the level of pulmonary obstruction and severity of disease. The predicted values will be calculated with the equations derived from Brazilian population.
Triaxial Accelerometry by Dynaport Activity Monitor: In order to evaluate the physical activity in daily life (PADL), it will be used DynaPort Activity Monitor (McRoberts BV®, Netherlands). Monitoring took place on four consecutive days lasting 12 hours from awakening. Data processing and analysis will be performed with the Dyrector software (McRoberts BV®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages II, III and IV);
- •Clinical stability in the past four weeks.
排除标准
- •Hospital admission in the past 12 weeks;
- •Any other disease or health condition that could compromise the test´s execution or physical training;
- •Participation in pulmonary rehabilitation program completed in the last six months;
- •Current smoking or its cessation in less than six months;
- •Interruption of pulmonary rehabilitation program for any reason;
- •Any change in symptoms during the study protocol assessments.
结局指标
主要结局
Morbidity
时间窗: Every month after the PRP up to 24 months
Relationship of changes in outcomes with exacerbation, hospitalization and death
Mortality
时间窗: Every month after the PRP up to 24 months
Relationship of changes in outcomes with death
Physical activity in daily life
时间窗: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Change in physical activity in daily life monitoring by accelerometry
次要结局
- Health status - COPD Assessment Test (CAT)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Health status - Saint George Respiratory questionnaire (SGRQ)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Dyspnea(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Anxiety and depression symptoms - Hospital Anxiety and Depression Scale (HADS)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Postural balance - Falls Efficacy Scale - International - Brasil (FES-I-Brasil)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Peripheral muscle oxygenation during exercise and activities of daily living (oxyhemoglobin)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Peripheral muscle oxygenation during exercise and activities of daily living (deoxyhemoglobin)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Functional status - London Chest Activity of Daily Living (LCADL)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Postural balance - Activities-specific Balance Confidence (ABC)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Peripheral muscle oxygenation during exercise and activities of daily living(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Functional status - Glittre-ADL Test (TGlittre)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Functional status - Six-Minute Walk Test (6MWT)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Postural balance - force platform NeuroCom (COP)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Motivation - External regulation(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Motivation - Introjected regulation(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Disease-specific self-efficacy(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Pulmonary Rehabilitation self-efficacy(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Postural balance - Berg Balance Scale (BBS)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Motivation - Intrinsic regulation(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- General Self-efficacy(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Basic Psychological Needs(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Postural balance - force platform NeuroCom (COG)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Postural balance -Timed Up and Go (TUG) Test(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Peripheral muscle oxygenation during exercise and activities of daily living (total hemoglobin)(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Motivation - Identified regulation(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Motivation - Amotivation(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
- Motivation - Self determination(baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP)
研究者
Prof. Dra. Anamaria Fleig Mayer
Principal Investigator
University of the State of Santa Catarina