- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05493384
Telerehabilitation in Rheumatic Diseases
6. august 2022 opdateret af: Songul Baglan Yentur, Gazi University
Telerehabilitation in Rheumatic Diseases During the Process of COVID-19 Pandemic
Telerehabilitation (TR) became more popular during COVID-19 pandemic due to social isolation and curfew.
Exercise is one of treatments for patients with rheumatic diseases that are known to have low levels of physical activity.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Telerehabilitation (TR) aims to decrease barriers such as distance, time and cost by using technology to patients and clinicians.
It provides to obtain rehabilitation for patients who cannot go to a medical center due to physical, environmental or economic inadequacies.
COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2).
It was firstly seen in December 2019 in Wuhan, China and spread rapidly all over the world.
World Health Organization (WHO) was declared COVID-19 as a pandemic in March 2020.
The most common symptoms are fever, cough and dyspnoea.
Social isolation and staying home have been suggested to reduce the spreading rate of COVID-19 pandemic in many countries.
In addition, curfew except necessity was applied in some countries and time of curfew varied by country.
Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression.
In addition, old age and having concomitant chronic disease are among risk factors for coronavirus.
Therefore, national health services recommend patients to practice self-isolation and self-quarantine.
However, social isolation was concluded with more increased physical inactivity and sedentary lifestyle.
Physical inactivity and disuse are proven to cause joint destruction, decreased aerobic capacity and muscle atrophy in patients with rheumatic diseases.The importance and requirement for TR were observed better during the COVID-19 pandemic.
Therefore, aim of this study was to investigate the effects of TR on fatigue, depression, anxiety, sleep quality, disease activity and quality of life.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Songul B Yentur
- Telefonnummer: +90 424 2370000
- E-mail: songulbaglan23@hotmail.com
Studiesteder
-
-
-
Elazığ, Kalkun, 23119
- Rekruttering
- Songul Baglan Yentur
-
Kontakt:
- Songul B Yentur
- Telefonnummer: +90 424 2370000
- E-mail: songulbaglan23@hotmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Between the ages of 18 to 65
- Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia
Exclusion Criteria:
- Being pregnant
- Diagnosed with malignancy
- Had changes of medical treatment in the last 3 months
- Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits
- Had regular exercise habit (minimally three days in a week)
- Had cardiac symphtoms according to New York Heart Association
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Telerehabilitation group
The Telerehabilitation Group will be performed exercise program including stretching, strengthening, posture and relaxation exercises by an experienced physiotherapist for 3 times a week for 8 weeks via Zoom.
|
The program will include stretching, strengthening, breathing, posture, proprioceptive, relaxation exercises and segmental extremity movements.
Each exercise will be performed 10 times in a session for the first 4 weeks and 15 times for the last 4 weeks.
Exercises will be performed progressively on the patients.
|
Ingen indgriben: No Intervention group
No additional therapy will be performed to the Control Group and they were suggested to continue their usual physical activity.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Træthedsgrad skala
Tidsramme: 2 minutter
|
Træthed er en normal reaktion på fysisk anstrengelse eller stress, men kan også være et tegn på en fysisk lidelse.
I almindelig sund fornuft er træthed en tilstand kendt af alle fra hans eller hendes egen erfaring, uanset hans eller hendes alder, køn eller helbred.
Træthedsskalaen består af ni spørgsmål; hvert spørgsmål gives fra 1 til 7
|
2 minutter
|
Hospital Anxiety and Depression Scale
Tidsramme: 2 minutes
|
It consists of 14 questions that which 7 of them evaluate depression and 7 of them evaluate anxiety.
Each question is scored from 0 to 3 and high scores indicate severe anxiety and depression
|
2 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pittsburg Sleep Quality Index
Tidsramme: 3 minutes
|
It assesses sleep quality and disturbances over a month's time interval and consists of 19 self-rated items and five questions.It contains 7 subscales and total score is sum of these subscales.
Each item is scored 0-3 and total score is changed between 0 to 21 which high scores indicate worse sleep quality.
|
3 minutes
|
Health Assessment Questionnaire
Tidsramme: 2 minutes
|
The questions of Health Assessment Questionnaire are about dressing and grooming, arising, eating, walking, hygiene, reach, grip and activity.
The questionnaire consists of 20 questions and each question is scored from 0 to 3. Higher scores indicate worse quality of life
|
2 minutes
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. juli 2022
Primær færdiggørelse (Forventet)
20. oktober 2022
Studieafslutning (Forventet)
20. november 2022
Datoer for studieregistrering
Først indsendt
2. august 2022
Først indsendt, der opfyldte QC-kriterier
6. august 2022
Først opslået (Faktiske)
9. august 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. august 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. august 2022
Sidst verificeret
1. august 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 7099
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Telerehabilitation Group
-
Gazi UniversityIkke rekrutterer endnuNeurologisk sygdomKalkun
-
NODEHealth FoundationAfsluttetMyokardieinfarkt | Myokardieiskæmi | Hjertesygdomme | Koronararteriesygdom | Angina, stabil | Hjertekrampe | Ventilsygdom, hjerte | Koronararteriestenose | Ventil hjertesygdomForenede Stater
-
Centro de Atenção ao Assoalho PélvicoIndústria Brasileira Equipamentos Médicos - IBRAMEDRekrutteringErektil dysfunktionBrasilien
-
Boston Medical CenterNational Institute of Mental Health (NIMH)AfsluttetPost traumatisk stress syndromForenede Stater
-
Hui-Hsun ChiangAfsluttetUddannelsesmæssige problemer | Ammende | Vold på arbejdspladsenTaiwan
-
Ayşegül İşler DalgıçHorizonIkke rekrutterer endnuStress, følelsesmæssig | Sundhedsrisikoadfærd | Sundhedsrelateret adfærd | Sund livsstil | Fysisk inaktivitet | Sund ernæring | Indeks for sund kost | Ikke-smitsomme sygdommeKalkun
-
RenJi HospitalIkke rekrutterer endnuFlydende reaktionsevne | Slagvolumen variation | SVV-FloTrac | Thorax elektrisk bioimpedansKina
-
RenJi HospitalIkke rekrutterer endnuFlydende reaktionsevne | Slagvolumen variation | SVV-FloTrac | Thorax elektrisk bioimpedansKina
-
University of California, San FranciscoMount Zion Health Fund; Pritzker Family Foundation; Mental Insight FoundationAfsluttetDepression, UnipolarForenede Stater
-
Shengjing HospitalRekruttering