Respiratory Muscle Training and Walking Exercise in Women Recovering From COVID-19 Pneumonia (RECOVID-EX)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Çorum
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Çorum、Çorum、トルコ（Türkiye）、19100
- Hitit University Çorum Erol Olçok Training and Research Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
|
介入なし：Control
Participants in this arm did not receive any structured exercise intervention and continued their usual daily routine during the study period.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Maximal Inspiratory Pressure
時間枠：Baseline and Week 8
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Change in maximal inspiratory pressure from baseline to post-intervention.
Maximal inspiratory pressure was used to assess inspiratory respiratory muscle strength.
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Baseline and Week 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Forced Vital Capacity
時間枠：Baseline and Week 8
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Change in forced vital capacity from baseline to Week 8. Forced vital capacity was assessed using pulmonary function testing and reported in liters.
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Baseline and Week 8
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Change in Forced Expiratory Volume in 1 Second
時間枠：Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Peak Inspiratory Flow
時間枠：Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Inspiratory Volume
時間枠：Baseline and Week 8
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Change in inspiratory volume from baseline to Week 8. Inspiratory volume was assessed as a respiratory function parameter and reported in liters.
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Baseline and Week 8
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Change in 6-Minute Walk Test Distance
時間枠：Baseline and Week 8
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Change in functional exercise capacity from baseline to post-intervention, assessed by the 6-minute walk test.
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Baseline and Week 8
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Change in Modified Borg Dyspnea Score
時間枠：Baseline and Week 8
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Change in perceived dyspnea from baseline to post-intervention, assessed using the modified Borg scale.
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Baseline and Week 8
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Change in Nottingham Health Profile Score
時間枠：Baseline and Week 8
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Change in health-related quality of life from baseline to post-intervention, assessed using the Nottingham Health Profile.
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Baseline and Week 8
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Change in Pittsburgh Sleep Quality Index Score
時間枠：Baseline and Week 8
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Change in sleep quality from baseline to post-intervention, assessed using the Pittsburgh Sleep Quality Index.
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Baseline and Week 8
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Change in Blood Parameters
時間枠：Baseline and Week 8
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Change in selected blood parameters from baseline to post-intervention, including leukocyte count, erythrocyte count, and hemoglobin.
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Baseline and Week 8
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2022-98
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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