The Effects of Telerehabilitation in Patients With COPD (COPD)
5. mai 2021 oppdatert av: Beyza Karakaş, Kırıkkale University
The Effects of Telerehabilitation on Respiratory Functions, Quality of Life, Exercise Capacity, Fatigue and Psychosocial Factors in Patients With COPD
Chronic Obstructive Pulmonary Disease is a serious public health problem worldwide and it is a leading cause of mortality and morbidity. Nowadays, COPD patients are increasing in all societies and the problems that arise during the life of these patients increase the need for care and rehabilitation. Pulmonary rehabilitation has proven to be the best supportive treatment for individuals with COPD. However, there are difficulties in rehabilitation practices in terms of the fragility of patients, transportation and access problems. Telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. There are different studies demonstrating the effect of telerehabilitation in COPD patients and confirming that it is safe, but it is a developing area and has a limited area of use.
In this randomized controlled study, it is aimed to examine the effect of telerehabilitation training on respiratory functions, exercise capacity, quality of life, fatigue and psychosocial factors in individuals with COPD via video conferencing including respiratory exercises and postural exercises.
Studieoversikt
Studietype
Intervensjonell
Registrering (Forventet)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Beyza Karakaş
- Telefonnummer: 05062187342
- E-post: beyzakarakas071@gmail.com
Studiesteder
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Kırıkkale, Tyrkia
- Rekruttering
- Kırıkkale High Specialization Hospital
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Ta kontakt med:
- Selma Demir
- Telefonnummer: 05054895758
- E-post: drmed64@gmail.com
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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
40 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Having been diagnosed with chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
- Not having an attack in the last 2 months
- Volunteering to participate in the study
- Being between the ages of 40-80
- To have a device that can be used in telerehabilitation application and an active internet connection.
Exclusion Criteria:
- Unstable angina, previous myocardial infarction, severe congestive heart failure resistant to medical therapy, uncontrolled hypertension, cancer, neurological or musculoskeletal disorders with functional limitations
- Currently addicted to alcohol or drugs
- Having an injury to the lower extremity such as sprains, sprains or fractures in the last 6 months, not being able to perform independent ambulation
- Having serious vision and hearing problems
- Having severe cognitive impairment
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Kontrollgruppe
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Eksperimentell: Behandlingsgruppe
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Telerehabilitation including pulmonary rehabilitation and posture exercises at 8 weeks in total with 2 sessions per week
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change from Baseline in respiratory functions on the spirometry at week 8
Tidsramme: Baseline - Week 8
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Spirometry is a standard test doctors use to measure how well your lungs are functioning.
The test works by measuring airflow into and out of your lungs.Spirometry measures two key factors: expiratory forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
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Baseline - Week 8
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Change from Baseline in exercise capacity on six-minute walk test at week 8
Tidsramme: Baseline - Week 8
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The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
The goal is for the individual to walk as far as possible in six minutes.A lower score (reflecting less distance covered in 6 minutes) indicates worse function.
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Baseline - Week 8
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Change from Baseline in health-related quality of life on Saint George's Respiratory Questionnaire at week 8
Tidsramme: Baseline - Week 8
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Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.Scores range from 0 to 100, with higher scores indicating more limitations.
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Baseline - Week 8
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Change from Baseline in psychosocial factors on Beck Depression and Beck Anxiety Inventory at week 8
Tidsramme: Baseline - Week 8
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Beck Depression Inventory is a self-assessment scale that determines the risk of individuals in terms of depression and measures the level of depressive symptoms and the change in severity.Beck Anxiety Inventory is a likert type self-assessment scale that determines the frequency of anxiety symptoms experienced by individuals.
The high score the individual gets from the scale indicates the severity of anxiety experienced.
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Baseline - Week 8
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Change from Baseline in fatigue on COPD and Asthma Fatigue Scale at week 8
Tidsramme: Baseline - Week 8
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The COPD and Asthma Fatigue Scale , was developed for use in clinical trials and other studies in respiratory diseases.
The COPD and Asthma Fatigue Scale was intended to be sufficiently comprehensive to capture fatigue experienced by patients with either asthma or COPD, yet be brief and patient centered.
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Baseline - Week 8
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change from Baseline in dyspnea on Modified Medical Research Council Dyspnea Scale at week 8
Tidsramme: Baseline - Week 8
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The modified Medical Research Council (mMRC) scale is the most commonly used validated scale to assess dyspnea in daily living in chronic respiratory diseases.
It is a scale scored between 0 and 5 based on various factors causing dyspnea.
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Baseline - Week 8
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Meral Sertel, Associate professor at Kırıkkale University
- Studieleder: Beyza Karakaş, Graduate student at Kırıkkale University
- Hovedetterforsker: Selma Demir, Chest Diseases Specialist at Kırıkkale High Specialization Hospital
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)
1. april 2021
Primær fullføring (Forventet)
1. september 2021
Studiet fullført (Forventet)
1. desember 2021
Datoer for studieregistrering
Først innsendt
5. mai 2021
Først innsendt som oppfylte QC-kriteriene
5. mai 2021
Først lagt ut (Faktiske)
10. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. mai 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. mai 2021
Sist bekreftet
1. mai 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- KKUniversity
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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