- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03588208
Progressive Resistance Training for Fibromyalgia
4. juli 2018 opdateret af: Anamaria Jones, Federal University of São Paulo
Evaluation of the Effectiveness of a Progressive Resistance Training Program for Patients With Fibromyalgia: a Randomized Controlled Trial
Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks.
The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum.
The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors.
In addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks.
Patients in the control group performed the same education program.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;
- Feminine gender;
- Age between 18 and 65 years;
- Pain between 3 and 8 cm in the Numerical Pain Scale (END);
- Have not changed treatment for fibromyalgia in the past three months;
- Agree to participate in the study and sign the informed consent form.
Exclusion Criteria:
- Cognitive deficit that does not allow the understanding of the evaluation instruments;
- Other diseases that make it impossible to perform the exercises;
- Physical activity started or changed in the last three months;
- Physical therapy in the last six months;
- In litigation.
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Interventionsgruppe
|
Progressive resistance training program were performed twice a week for 12 weeks.
The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum.
The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors.
In addition to strength training.
Structured education program were performed during one hour class once a week for five weeks
|
|
Aktiv komparator: Kontrolgruppe
|
Structured education program were performed during one hour class once a week for five weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in pain
Tidsramme: Baseline and after 6 and 12 weeks
|
Measured by numerical pain scale
|
Baseline and after 6 and 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Health related quality of life
Tidsramme: Baseline and after 6 and 12 weeks
|
Measured by Fibromyalgia Impact Questionnaire
|
Baseline and after 6 and 12 weeks
|
|
Change in Generic quality of life
Tidsramme: Baseline and after 6 and 12 weeks
|
Measured by the Medical Outcome Survey Short Form 36
|
Baseline and after 6 and 12 weeks
|
|
Change in Functional capacity
Tidsramme: Baseline and after 6 and 12 weeks
|
Measured by the 6-minute Walk Test
|
Baseline and after 6 and 12 weeks
|
|
Change in strength
Tidsramme: Baseline and after 6 and 12 weeks
|
Measured by the 1 repetition maximum
|
Baseline and after 6 and 12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. februar 2016
Primær færdiggørelse (Faktiske)
2. september 2017
Studieafslutning (Faktiske)
25. marts 2018
Datoer for studieregistrering
Først indsendt
4. juli 2018
Først indsendt, der opfyldte QC-kriterier
4. juli 2018
Først opslået (Faktiske)
17. juli 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CEP UNIFESP 482056
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