- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05375422
Effects of SARAH Protocol in Women With Rheumatoid Arthritis
11. mai 2022 oppdatert av: Samira Tatiyama Miyamoto, PhD, Federal University of Espirito Santo
Effects of the Strengthening and Stretching Protocol for Rheumatoid Arthritis in the Hands (SARAH) on Hand Function in Women With Rheumatoid Arthritis
The aim of this randomized controlled trial is to analyze the effect of the SARAH protocol, which is a set of exercises with components of muscle strengthening, range of motion gain and home exercises, combined with an educational intervention, on hand function in women with rheumatoid arthritis (RA).
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The volunteers will be randomized between groups: control group (n=30), which will receive usual guidelines and the SARAH group (n=30), which will perform the SARAH protocol exercises (brazilian portuguese version) along with the usual guidelines.
To participate in the research, patients must be diagnosed with RA using disease-modifying antirheumatic medication for at least 3 months, and age equal to or older to 18 years.
Participants with incomplete elementary school and score <24 on the Mini-Mental State Examination Questionnaire (MMSE) will be excluded from the study.
The participants will be evaluated before and after the intervention regarding the variables: hand function (Michigan Hand Outcomes Questionnaire), pain (Brief Pain Inventory), handgrip strength (Jamar® manual dynamometer), quality of life (Euro Quality of Life Instrument-5D), functional capacity (Health Assessment Questionnaire), RA disease activity (DAS28).
The SARAH group will receive an exercise book containing 7 mobility exercises and 4 strength exercises that are performed using elastic materials that provide progressive degrees of resistance to movement.
Patients will be guided in person by a trained professional, so that they are carried out without their presence, in the home environment, daily and monitored at periodically scheduled meetings.
A total of 4 face-to-face meetings will be held during the 3-month follow-up.
The SARAH group and the control group will receive information related to joint protection, use of splints, assistive devices and other general advice, as needed, will receive some booklets to reinforce the guidelines.
The program will last 12 weeks, with 4 face-to-face meetings lasting 40 minutes and monitored in periodically scheduled meetings.
Studietype
Intervensjonell
Registrering (Forventet)
60
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: Samira T Miyamoto, PhD
- Telefonnummer: +55 27 997606447
- E-post: sa.miyamoto@hotmail.com
Studer Kontakt Backup
- Navn: Ludmila Forechi, PhD
- Telefonnummer: +55 21 998132300
- E-post: ludimilaforechi@yahoo.com.br
Studiesteder
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ES
-
Vitória, ES, Brasil, 29050-780
- Rekruttering
- Samira Tatiyama Miyamoto, PhD
-
Ta kontakt med:
- Samira T Miyamoto, PhD
- Telefonnummer: +55 27 997606447
- E-post: sa.miyamoto@hotmail.com
-
-
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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- patients must be diagnosed with RA
- using disease-modifying antirheumatic medication for at least 3 months
- over 18 years old
Exclusion Criteria:
- incomplete elementary school and score <24 on the Mini-Mental State Examination Questionnaire (MMSE)
- diagnosis of another associated autoimmune disease
- having undergone previous surgical procedures on the hands
- having suffered a fracture in the joints of the upper limbs in the last six months
- being a patient on the waiting list for orthopedic surgery of the upper limb
- being pregnant.
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: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: SARAH group
The SARAH group will receive an exercise book containing 7 mobility exercises and 4 strength exercises that are performed using elastic materials that provide progressive degrees of resistance to movement.
Patients will be guided in person by a trained professional, so that they are carried out without their presence, in the home environment, daily and monitored at periodically scheduled meetings.
A total of 4 face-to-face meetings will be held during the 3-month follow-up.
The SARAH group and the control group will receive information related to joint protection, use of splints, assistive devices and other general advice, as needed, will receive some booklets to reinforce the guidelines.
The program will last 12 weeks, with 4 face-to-face meetings lasting 40 minutes and monitored in periodically scheduled meetings.
|
Set of exercises with components of muscle strengthening, range of motion gain and home exercises.
Information related to joint protection, use of splints, assistive devices and other general advice, as needed.
|
Aktiv komparator: Control group
Control group will receive information related to joint protection, use of splints, assistive devices and other general advice, as needed, will receive some booklets to reinforce the guidelines. After 12 weeks, the control group will also be invited to perform the SARAH protocol exercises. |
Information related to joint protection, use of splints, assistive devices and other general advice, as needed.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Hand function
Tidsramme: 3 months
|
Michigan Hand Outcomes Questionnaire.
A total of 37 items assess six domains: general hand function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction with hand function.
The participant must score each item using Likert-type scales ranging from 1 to 5.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pain inventory
Tidsramme: 3 months
|
Brief Pain Inventory.
It classifies pain as mild when scored from 1 to 4, moderate when scored from 5 to 7, and severe when the participant selects values from 8 to 10 points.
|
3 months
|
Hand grip strength
Tidsramme: 3 months
|
Hand dynamometer.
The participant should press the dynamometer with maximum force for 3 seconds and rest for 60 seconds.
All values must be recorded for later calculation of the average of three attempts.
|
3 months
|
Healthy related quality of life
Tidsramme: 3 months
|
Euro Quality of Life Instrument-5D (EQ-5D).
The questionnaire consists of questions about health and disease states, such as: mobility, personal care, usual activities, pain/discomfort, anxiety/depression, and each of these has three associated levels of severity, corresponding to no problems (level 1).
), some problems (level 2) and extreme problems (level 3) experienced or felt by the individual.
|
3 months
|
Functional capacity
Tidsramme: 3 months
|
Health Assesment Questionnaire (HAQ).
Eight categories with scores from 0 (no problem) to 3 (unable to do) per category.
The score for each category appears at the highest number of any of its items, and the final HAQ score is the average of the scores for the eight categories.
|
3 months
|
Disease activity
Tidsramme: 3 months
|
Disease Activity Score (DAS-28).
The DAS-28 score can be interpreted on a categorical scale: it is indicative of disease remission values <2.6, light activity when it has a result between 2.6 and 3.2, moderate activity when values >3.2 to 5, 1 and high disease activity when the result is greater than 5.1.
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3 months
|
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)
7. februar 2022
Primær fullføring (Faktiske)
7. mai 2022
Studiet fullført (Forventet)
7. februar 2024
Datoer for studieregistrering
Først innsendt
11. mai 2022
Først innsendt som oppfylte QC-kriteriene
11. mai 2022
Først lagt ut (Faktiske)
16. mai 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2022
Sist bekreftet
1. mai 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FUEspiritoSanto03
Plan for individuelle deltakerdata (IPD)
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NEI
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