Effects of an Early Rehabilitation Program During Hospitalization in Adolescents and Adults Patients With Cystic Fibrosis: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Distance walked during the six minute walk test
研究概览
简要总结
Studies demonstrate that exercise increases the maximal oxygen uptake, peak oxygen consumption, reduce effort-induced lactic acid production, and increase skeletal muscle oxidative capacity, as well as psychological aspects such as increased self-esteem and improvement of the quality of life.
In the literature there is only one study involving rehabilitation in hospitalized pediatric patients with cystic fibrosis. Thus, more information on in-hospital rehabilitation is required in adult cystic fibrosis patients.
The present study aims to evaluate the effects of an early rehabilitation program, based on aerobic training and muscle strength training, in adolescent and adult patients with cystic fibrosis hospitalized at Hospital de Clinicas de Porto Alegre for exacerbation of lung disease.
详细描述
After completing the study inclusion criteria, the individual will be invited to participate and will receive the consent form for signature.
The patient will be submitted to the following evaluations: quality of life questionnaire for cystic fibrosis, spirometry, Shwachman-Kulczycki score, modified dyspnea questionnaire (Modified Medical Research Council), maximum repetition test, six minute walk test and blood sample for the determination of inflammatory markers. These evaluations should be performed within the first 48 hours of hospitalization, and will be repeated on the last day of hospitalization.
In the period up to 48 hours after hospital admission, patients will be randomized to either the intervention group or the control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16 years and older,
- •Regularly followed up in the Hospital de Clinicas de Porto Alegre Program for Adolescents and Adults with Cystic Fibrosis with a diagnosis of cystic fibrosis confirmed according to the consensus criteria,
- •Admitted to hospital admission due to exacerbation of lung disease.
- •Hospital stay will be defined as the stay equal to or greater than 24 hours in any Hospital de Clinicas de Porto Alegre unit.
排除标准
- •Patients with cardiac, orthopedic or trauma complications that make it impossible to perform the proposed exercises;
- •Pregnant patients;
- •Patients with hemodynamic instability, massive hemoptysis, pneumothorax, and continuous use of noninvasive ventilation.
研究组 & 干预措施
Control
Patients randomized to the control group will continue to receive the physiotherapeutic follow-up performed by the physiotherapist of the Program for Adults with CF during the hospitalization period. Supervision includes respiratory physiotherapy involving inhalation therapy and techniques for removal of secretions.
干预措施: Control (Other)
Exercise
Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive an early rehabilitation program, which will begin within the first 48 hours after admission. The patient will perform physical training (aerobic and anaerobic) 5 times a week during the hospitalization period, with sessions about an hour. The professional who supervises the training will be blinded to the results of the measurements.
干预措施: Exercise (Other)
结局指标
主要结局
Distance walked during the six minute walk test
时间窗: up to 14 days
The six-minute walk test will be performed at hospital discharge.
次要结局
- Cystic fibrosis quality of life questionary(up to 14 days)
- Interleukin-8(up to 14 days)
- Forced expiratory volume in the first second(up to 14 days)
- Tumor necrosis factor(up to 14 days)
- C-reative protein(up to 14 days)
- Interleukin-6(up to 14 days)