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Vergelijking van pulmonale telerevalidatie en aanbevelingen voor lichaamsbeweging bij patiënten met postcovid-fibrose

29 september 2026 bijgewerkt door: Ozge Ertan, Istanbul University - Cerrahpasa

Vergelijking van de effectiviteit van longtelerevalidatie en aanbevelingen voor lichaamsbeweging bij patiënten met longfibrose als gevolg van COVID-19

Rehabilitation plays a very important role in the management of patients with COVID-19, focusing on respiratory and motor functions, and therefore the importance of establishing treatment strategies to ensure optimal recovery of these patients has been emphasized. It has been stated that physical activity recommendations should be clarified for the management of symptoms associated with prolonged COVID-19 Syndrome and for the continuation of activities of daily living. It has been stated that after COVID-19 pneumonia, it is necessary to evaluate the physical functions of patients with long-term follow-up and to establish rehabilitation programs. The importance of being included in the rehabilitation program was emphasized, especially for patients with lung fibrosis.

The primary aim of this study was to compare the effects of pulmonary telerehabilitation and physical activity recommendations on exercise capacity and peripheral muscle strength in patients with pulmonary fibrosis due to COVID-19.

The secondary aim of this study is to compare the effects of pulmonary telerehabilitation and physical activity recommendations on symptoms, activity and participation in patients with pulmonary fibrosis due to COVID-19.

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

30

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

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

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • >18 years old
  • Patients who have been infected with the COVID-19 virus at least 12 months ago and have been diagnosed with a positive PCR
  • Patients with post-COVID-19 pulmonary fibrosis followed by a pulmonologist
  • Patients who have sufficient technological infrastructure to participate in the telerehabilitation program and can adapt to online systems
  • Patients who are clinically stable

Exclusion Criteria:

  • Patients with orthopedic/neurological problems that prevent walking and exercise
  • Patients with uncontrolled cardiovascular disease
  • Patients with uncontrolled medical conditions

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: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Pulmonary Rehabilitation Group

A total of 24 sessions of breathing exercises and high-repetitive muscle endurance and strengthening exercises will be applied to the pulmonary telerehabilitation group for 8 weeks, two days a week and one day a week unsupervised, via online systems. High-repetition muscle endurance and strengthening exercises will be applied to large muscle groups of the lower and upper extremities by creating resistance with body weight and theraband.

High repetition muscle endurance and strengthening exercises Walking

Actieve vergelijker: Physical Activity Group

Respiratory exercises and physical activity recommendations will be given to the physical activity group. Physical activity recommendations are; It will include information about the importance of physical activity and walking 3-5 days a week for at least 30 minutes of moderate intensity (4-6 on the Modified Borg scale of perceived exertion level).

High repetition muscle endurance and strengthening exercises Walking

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Submaximal exercise capacity
Tijdsspanne: 1 week-8 week

Six minute walk test and

1 week-8 week
maximal exercise capacity
Tijdsspanne: 1 week-8 week

Incremental shuttle walk test

1 week-8 week
endurance exercise capacity
Tijdsspanne: 1 week-8 week

endurance shuttle walk test

1 week-8 week
Peripheral muscle strength
Tijdsspanne: 1 week-8 week

Hand-held dynamometer

1 week-8 week
Functional exercise capacity
Tijdsspanne: 1 week-8 week

1 min sit to stand test

1 week-8 week

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical activity
Tijdsspanne: 1 week-8 week also Participants will monitor their weekly step counts during the study

Pedometer

1 week-8 week also Participants will monitor their weekly step counts during the study
Physical activity
Tijdsspanne: 1 week-8 week

Physical activity will be assessed using a SenseWear Armband (BodyMedia Inc., Pittsburgh, PA, USA), worn for at least 72 hours.

1 week-8 week
Dyspnea
Tijdsspanne: 1 week-8 week

Modified Medical Research Council Dyspnea Scale stratifies severity of dyspnea in respiratory diseases. The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing

1 week-8 week
Fatigue
Tijdsspanne: 1 week-8 week

The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on patients. The FSS is a short questionnaire that requires to rate your level of fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. Patients read each statement and circle a number from 1 to 7, based on how accurately it reflects their condition during the past week and how much they agree or disagree that the statement applies to patients. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. Total score between 9-63. A total score of less than 36 suggests that you may not be suffering from fatigue.

1 week-8 week
Functionality
Tijdsspanne: 1 week-8 week

Post covid-19 functionality scale (PCFS): The PCFS scale stratifies functional status limitation as follows: grade 0 (No functional limitations), grade 1 (Negligible functional limitations), grade 2 (Slight functional limitations), grade 3 (Moderate functional limitations), grade 4 (Severe functional limitations), and grade 5 (death)

1 week-8 week
Emotional status
Tijdsspanne: 1 week-8 week

Hospital anxiety and depression scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).

1 week-8 week
Body composition
Tijdsspanne: 1 week-8 week

Bioelectrical impedence analysis

1 week-8 week
Activities of daily living
Tijdsspanne: 1 week-8 week

London chest activity of daily living scale: Perceived dyspnea while performing daily living activities is scored between 0-5. A high score indicates greater disability in performing ADLs. The minimum score 0 and maximum total score is 75.

1 week-8 week

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pulmonary Telerehabilitation Feasibility
Tijdsspanne: 8 week

Changes in clinical status will be assessed using the 'Global Change Scale' in order to determine the programme's effect on clinical status.

8 week
Pulmonary Telerehabilitation Feasibility
Tijdsspanne: 8 week

Adherence and drop-out rate

8 week
Pulmonary Telerehabilitation Feasibility
Tijdsspanne: 8 week

System usability: The usability of the telerehabilitation system was assessed using the "System Usability Scale (SUS)".

8 week
Pulmonary Telerehabilitation Feasibility
Tijdsspanne: 8 week

Safety

8 week

Medewerkers en onderzoekers

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

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)

4 september 2022

Primaire voltooiing (Werkelijk)

7 maart 2025

Studie voltooiing (Werkelijk)

7 maart 2025

Studieregistratiedata

Eerst ingediend

25 maart 2022

Eerst ingediend dat voldeed aan de QC-criteria

28 maart 2022

Eerst geplaatst (Werkelijk)

29 maart 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

29 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

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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