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临床试验/NCT02731482
NCT02731482已完成不适用

Short-and Long-term Effects of a Home-based Rehabilitation Program on Functional Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: Randomized Controlled Trial

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Distance, in meters, performed in the Incremental Shuttle Walk Test

研究概览

简要总结

This study will investigate the short-and long-term effects of the home-based pulmonary rehabilitation on peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. The participants will be randomized into two groups: control group (usual care and recommendations for practice exercise) and training group, that will perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight weeks, three times a week. At baseline, immediately after finishing and after six months the patients will undergo assessments.

详细描述

Home-based pulmonary rehabilitation (HBPR) has been used in patients with chronic obstructive pulmonary disease, asthma and pulmonary fibrosis. Results from HBPR have been similar to those observe in the outpatient pulmonary rehabilitation such improvement in exercise capacity, symptoms and quality of life. However, HBPR has not yet been investigated in patients with bronchiectasis, a progressive and debilitating disease with a high socioeconomic impact. Objective: To investigate the short-and long-term effects of the home rehabilitation program in peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. Methods: Patients diagnosed with bronchiectasis will be recruited from the Obstructive Diseases Outpatient Clinic of the Hospital das Clínicas - Medicine School, University of São Paulo. Participants will be randomized into two groups: control group (usual care and recommendations for performing exercises and respiratory physiotherapy) and training group, that will perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight weeks, three times a week. All patients will receive a phone call once a week and patients allocated to the training group, additionally, will get a home visit every 15 days. At baseline, immediately after finishing and after six months of the HBPR patients will undergo to assessments. Expected results: HBPR will have positive effects on exercise tolerance and quality of life. Also, this study will contribute to future guidelines on the recommendation of HBPR for patients with bronchiectasis.

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 (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis and/or tomographic bronchiectasis Clinically stable (no change in symptoms of dyspnea, in the amount and color of the secretion) Have completed the outpatient pulmonary rehabilitation for more than a year Not engaged in a regular physical activity.

排除标准

  • Smokers With other lung related diseases (asthma, COPD and cystic fibrosis) Severe cardiovascular diseases Musculoskeletal limitation Unable to perform the tests and the training protocol due desaturation (pulse oxygen saturation ≤ 80%) over the recommended exercise intensity.

研究组 & 干预措施

Training Group

Experimental

Patients with bronchiectasis in home-based pulmonary rehabilitation

干预措施: Training Group (Other)

Control Group

Active Comparator

Patients with bronchiectasis in usual care and recommendations for performing exercises

干预措施: Control Group (Other)

结局指标

主要结局

Distance, in meters, performed in the Incremental Shuttle Walk Test

时间窗: up to 9 months

Measurement of functional capacity and exercise tolerance

次要结局

  • Time, in seconds, performed in the Endurance Shuttle Walk Test(up to 9 monthsst)
  • Kilogram-force (kgf) of quadriceps femoris(up to 9 months)
  • Number of steps performed in the Incremental Step Test(up to 9 months)
  • Physical functioning domain scale in the Quality of Life Questionnaire-Bronchiectasis (QoL-B)(up to 9 months)
  • Number of steps per day, measured by a pedometer(up to 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anderson José

PT, PhD

University of Nove de Julho

研究点 (2)

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