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临床试验/NCT06091280
NCT06091280已完成不适用

Home-Based Respiratory Muscle Strength Training Program for Individuals With Post-COVID-19 Persistent Dyspnea

University of South Florida2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Modified Medical Research Council Scale

研究概览

简要总结

To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory breathing exercises compared to expiratory breathing exercises alone will help to improve shortness of breath, respiratory symptoms, breathing function, distance walked, and quality of life in those who are experiencing persistent shortness of breath after having had COVID-19. Measurements will take place at the beginning, 6 weeks, and at 12 weeks in the study.

详细描述

To evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory muscle strength training exercises as compared to a prior study of expiratory muscle strength training alone is effective in improving dyspnea, respiratory symptoms, quantitative measures of pulmonary function, physical performance, and quality of life in individuals reporting persistent dyspnea post-COVID-19 at baseline, six and twelve weeks.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-reported history of a positive COVID-19 diagnosis in the past.
  • Able to walk independently
  • Cognitively intact
  • English-speaking
  • Dyspnea at rest or with activity rated at 3 or greater on the Dyspnea on Exertion scale.
  • May use oxygen.
  • May be taking medications.

排除标准

  • Individuals who are wheelchair bound or who cannot walk independently.
  • Individuals hospitalized for COVID-19 who self-report that they received mechanical ventilation during hospitalization.

结局指标

主要结局

Modified Medical Research Council Scale

时间窗: Baseline, 6-weeks, and 12-week measurements

Scale of 0-4 with 4 being the most severe dyspnea.

COPD Assessment Test

时间窗: Baseline, 6-weeks, and 12-week measurements.

8-item questionnaire with a semantic, 6-point differential scale for each item. Scores range from 0-40 with higher scores indicating more severe respiratory symptoms.

EuroQoL-5 Dimension-5 Level

时间窗: Baseline, 6-weeks, and 12-week measurements.

EuroQoL-5 Dimension-5 Level to evaluate 5 dimensions of quality of life including mobility, self-care, usual activities, discomfort and pain, anxiety, and depression. Each is scored using a 5-point semantic scale.

Forced Expiratory Volume over 1 second (FEV1)

时间窗: Baseline, 6-weeks, and 12-week measurements

Using the Microlife Digital Peak Flow and FEV1 Meter (Clearwater, FL).

Peak Inspiratory Flow

时间窗: Baseline, 6-weeks, and 12-week measurements.

Using the In-Check Peak Inspiratory Flow meter (Granbury, TX).

Thoracic Expansion Measures

时间窗: Baseline, 6-weeks, and 12-week measurements

Gulick tape measure positioned around the participant's chest at the 4th intercostal space. Participant breathes in and out as far as possible and the difference between the 2 values equals thoracic expansion.

Physical Capacity

时间窗: Baseline, 6-weeks, and 12-week measurements.

6 Minute Walk Test following the American Thoracic Society Procedure: 50-meter distance is marked. Participant walks as quickly as possible for 6 minutes. Results recorded in meters. Vital signs and oxygen saturation monitored and recorded.

次要结局

  • Feasibility and Acceptability of the Intervention(12-weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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