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

15 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
    • Çorum
      • Çorum, Çorum, Turkije (Türkiye), 19100
        • Hitit University Çorum Erol Olçok Training and Research Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Respiratory Muscle Training
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.
Experimenteel: 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.
Gedragsmatig: Respiratory Muscle Training
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.
Gedragsmatig: Walking Exercise
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.
Experimenteel: 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.
Gedragsmatig: Walking Exercise
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.
Geen tussenkomst: Control
Participants in this arm did not receive any structured exercise intervention and continued their usual daily routine during the study period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Maximal Inspiratory Pressure
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Forced Vital Capacity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hitit University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • 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.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 januari 2023

Primaire voltooiing (Werkelijk)

26 mei 2023

Studie voltooiing (Werkelijk)

29 mei 2023

Studieregistratiedata

Eerst ingediend

11 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 juni 2026

Eerst geplaatst (Werkelijk)

18 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

15 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2022-98

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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