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Sammenligning av pulmonal telerehabilitering og fysisk aktivitetsanbefalinger hos pasienter med post covid fibrose

29. september 2026 oppdatert av: Ozge Ertan, Istanbul University - Cerrahpasa

Sammenligning av effektiviteten av pulmonal telerehabilitering og fysisk aktivitetsanbefalinger hos pasienter med lungefibrose på grunn av 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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

Aktiv komparator: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Submaximal exercise capacity
Tidsramme: 1 week-8 week

Six minute walk test and

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

Incremental shuttle walk test

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

endurance shuttle walk test

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

Hand-held dynamometer

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

1 min sit to stand test

1 week-8 week

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 week-8 week

Bioelectrical impedence analysis

1 week-8 week
Activities of daily living
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pulmonary Telerehabilitation Feasibility
Tidsramme: 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
Tidsramme: 8 week

Adherence and drop-out rate

8 week
Pulmonary Telerehabilitation Feasibility
Tidsramme: 8 week

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

8 week
Pulmonary Telerehabilitation Feasibility
Tidsramme: 8 week

Safety

8 week

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. september 2022

Primær fullføring (Faktiske)

7. mars 2025

Studiet fullført (Faktiske)

7. mars 2025

Datoer for studieregistrering

Først innsendt

25. mars 2022

Først innsendt som oppfylte QC-kriteriene

28. mars 2022

Først lagt ut (Faktiske)

29. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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