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Respiratory Muscle Training and Walking Exercise in Women Recovering From COVID-19 Pneumonia (RECOVID-EX)

2026年6月15日 更新者:Mehmet İsmail TOSUN、Hitit University

Investigation of the Effects of Respiratory Muscle Training and Walking Exercises on Some Blood and Respiratory Parameters in Patients Recovering From COVID-19 Lung Inflammation

This experimental study was designed to investigate the effects of respiratory muscle training and walking exercise on selected blood, respiratory, functional, dyspnea, sleep quality, and quality-of-life outcomes in women who had recovered from COVID-19-related lung inflammation/pneumonia. The study included women aged 20 to 45 years who had experienced COVID-19 with pneumonia, reported dyspnea, and had reduced quality of life.

A total of 80 female participants were divided into four groups: respiratory muscle training plus walking exercise, respiratory muscle training alone, walking exercise alone, and a control group, with 20 participants in each group. Measurements were performed before and after the intervention period. The assessments included pulmonary function testing, maximal inspiratory pressure, the 6-minute walk test, the modified Borg scale for dyspnea, the Nottingham Health Profile, the Pittsburgh Sleep Quality Index, and selected blood parameters. The study aimed to determine whether respiratory muscle training, walking exercise, or their combination could improve respiratory function, inspiratory muscle strength, functional capacity, dyspnea, sleep quality, quality of life, and blood-related parameters in this population.

研究概览

详细说明

This was a single-blind, experimental, pretest-posttest intervention study conducted in adult women who had recovered from COVID-19-related pneumonia and continued to experience dyspnea during the post-discharge period. Participants were recruited from routine post-discharge follow-up settings and were informed about the study procedures before participation. Written informed consent was obtained from all participants before any study-related procedures were performed.

Before the start of the intervention period, participants completed a familiarization session and trial measurements to reduce learning-related variability during the actual assessments. Baseline measurements were then performed, and participants were allocated into four study groups according to their pretest results: respiratory muscle training, respiratory muscle training plus walking exercise, walking exercise, and control.

The respiratory muscle training intervention was performed for 8 weeks using a pressure-threshold respiratory muscle training device. The training load was set at 50% of each participant's maximal inspiratory pressure. Participants in the respiratory muscle training group performed the intervention 5 days per week, twice daily, with 30 breaths in each session. Respiratory muscle strength was reassessed weekly, and the training load was updated according to changes in maximal inspiratory pressure.

The combined intervention group completed the same respiratory muscle training protocol in addition to a structured walking exercise program. The walking exercise consisted of 40 minutes of walking, 3 days per week, either outdoors or on a treadmill, at a pace of approximately 4 to 6 km/hour. Exercise intensity was prescribed using a target heart rate approach corresponding to 40% intensity and was monitored during the sessions with an optical heart rate sensor. Before walking exercise, participants completed a 10-minute warm-up and stretching routine for the upper and lower extremities.

The walking exercise group completed only the structured walking program using the same frequency, duration, intensity, and monitoring procedures as the walking component of the combined intervention group. The control group did not receive a structured exercise intervention and continued their usual daily routine during the study period.

Study data were collected using individual participant forms. These forms included health history, medication use, smoking status, previous physical activity status, basic physical characteristics, and all pre- and post-intervention measurement values. The intervention process and exercise sessions were monitored throughout the study period. Measurements were repeated after the 8-week intervention period to evaluate changes within and between the study groups.

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Çorum
      • Çorum、Çorum、土耳其(türkiye)、19100
        • Hitit University Çorum Erol Olçok Training and Research Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Female participants aged 20 to 45 years
  • History of COVID-19-related pneumonia
  • Presence of dyspnea after COVID-19
  • Modified Borg dyspnea score between 1 and 7 after the 6-minute walk test
  • Resting oxygen saturation between 90% and 95%
  • Incomplete resolution of COVID-19-related lesions on chest radiography
  • Voluntary agreement to participate in the study
  • Signed written informed consent form

Exclusion Criteria:

  • Modified Borg dyspnea score between 0 and 1
  • Modified Borg dyspnea score greater than 7
  • History of chronic obstructive pulmonary disease, heart failure, or pulmonary fibrosis causing dyspnea before COVID-19 pneumonia
  • Upper abdominal or thoracic surgery within the previous 3 months
  • Cancer
  • Pregnancy
  • Presence of another disease contributing to dyspnea in addition to COVID-19-related dyspnea
  • Cardiovascular, musculoskeletal, or nervous system involvement related to COVID-19
  • Mental disorder or mental instability
  • Language barrier preventing understanding of Turkish
  • Refusal to participate or withdrawal from the study at any stage
  • History of being a competitive athlete
  • Lack of voluntary participation or refusal to sign the written informed consent form

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Respiratory Muscle Training
Participants in this arm received respiratory muscle training for 8 weeks using a pressure-threshold respiratory muscle training device. The training intensity was set at 50% of each participant's maximal inspiratory pressure and was updated according to weekly changes in respiratory muscle strength.
Participants performed respiratory muscle training for 8 weeks using a pressure-threshold respiratory muscle training device. The training load was set at 50% of each participant's maximal inspiratory pressure. Training was performed 5 days per week, twice daily, with 30 breaths in each session. Maximal inspiratory pressure was reassessed weekly, and the training load was adjusted according to the updated value.
实验性的:Respiratory Muscle Training Plus Walking Exercise
Participants in this arm received respiratory muscle training in addition to a structured walking exercise program for 8 weeks. The walking exercise was performed 3 days per week for 40 minutes at 40% intensity based on the target heart rate method, either outdoors or on a treadmill. Exercise intensity was monitored using an optical heart rate sensor.
Participants performed respiratory muscle training for 8 weeks using a pressure-threshold respiratory muscle training device. The training load was set at 50% of each participant's maximal inspiratory pressure. Training was performed 5 days per week, twice daily, with 30 breaths in each session. Maximal inspiratory pressure was reassessed weekly, and the training load was adjusted according to the updated value.
Participants performed a structured walking exercise program for 8 weeks. Walking exercise was performed 3 days per week for 40 minutes at an intensity corresponding to 40% based on the target heart rate method. Walking was performed either outdoors or on a treadmill at an approximate pace of 4 to 6 km/hour. Exercise intensity was monitored using a Polar Verity Sense optical heart rate sensor. Before walking, participants completed a 10-minute warm-up and stretching protocol for the upper and lower extremities.
实验性的:Walking Exercise
Participants in this arm performed structured walking exercise for 8 weeks. Walking was performed 3 days per week for 40 minutes at a pace of approximately 4-6 km/hour and at 40% intensity based on the target heart rate method. Exercise intensity was monitored during the sessions using an optical heart rate sensor.
Participants performed a structured walking exercise program for 8 weeks. Walking exercise was performed 3 days per week for 40 minutes at an intensity corresponding to 40% based on the target heart rate method. Walking was performed either outdoors or on a treadmill at an approximate pace of 4 to 6 km/hour. Exercise intensity was monitored using a Polar Verity Sense optical heart rate sensor. Before walking, participants completed a 10-minute warm-up and stretching protocol for the upper and lower extremities.
无干预:Control
Participants in this arm did not receive any structured exercise intervention and continued their usual daily routine during the study period.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Maximal Inspiratory Pressure
大体时间:Baseline and Week 8
Change in maximal inspiratory pressure from baseline to post-intervention. Maximal inspiratory pressure was used to assess inspiratory respiratory muscle strength.
Baseline and Week 8

次要结果测量

结果测量
措施说明
大体时间
Change in Forced Vital Capacity
大体时间:Baseline and Week 8
Change in forced vital capacity from baseline to Week 8. Forced vital capacity was assessed using pulmonary function testing and reported in liters.
Baseline and Week 8
Change in Forced Expiratory Volume in 1 Second
大体时间:Baseline and Week 8
Change in forced expiratory volume in 1 second from baseline to Week 8. Forced expiratory volume in 1 second was assessed using pulmonary function testing and reported in liters.
Baseline and Week 8
Change in Peak Inspiratory Flow
大体时间:Baseline and Week 8
Change in peak inspiratory flow from baseline to Week 8. Peak inspiratory flow was assessed as a respiratory function parameter and reported in liters per second.
Baseline and Week 8
Change in Inspiratory Volume
大体时间:Baseline and Week 8
Change in inspiratory volume from baseline to Week 8. Inspiratory volume was assessed as a respiratory function parameter and reported in liters.
Baseline and Week 8
Change in 6-Minute Walk Test Distance
大体时间:Baseline and Week 8
Change in functional exercise capacity from baseline to post-intervention, assessed by the 6-minute walk test.
Baseline and Week 8
Change in Modified Borg Dyspnea Score
大体时间:Baseline and Week 8
Change in perceived dyspnea from baseline to post-intervention, assessed using the modified Borg scale.
Baseline and Week 8
Change in Nottingham Health Profile Score
大体时间:Baseline and Week 8
Change in health-related quality of life from baseline to post-intervention, assessed using the Nottingham Health Profile.
Baseline and Week 8
Change in Pittsburgh Sleep Quality Index Score
大体时间:Baseline and Week 8
Change in sleep quality from baseline to post-intervention, assessed using the Pittsburgh Sleep Quality Index.
Baseline and Week 8
Change in Blood Parameters
大体时间:Baseline and Week 8
Change in selected blood parameters from baseline to post-intervention, including leukocyte count, erythrocyte count, and hemoglobin.
Baseline and Week 8

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • Tosun MI. Investigation of the Effects of Respiratory Muscle Training and Walking Exercises on Some Blood and Respiratory Parameters in Patients Recovered From COVID-19 Lung Inflammation. Doctoral dissertation. Hitit University, Graduate School, Department of Physical Education and Sports; 2023.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年1月16日

初级完成 (实际的)

2023年5月26日

研究完成 (实际的)

2023年5月29日

研究注册日期

首次提交

2026年6月11日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared publicly because the dataset contains personal health-related information collected from female participants who had recovered from COVID-19-related pneumonia. The data were collected as part of a doctoral thesis study and were analyzed in de-identified form for the purposes of the study.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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