- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02219022
Progressive Resistance Exercise in Rheumatoid Arthritis
Progressive Resistance Exercise in Rheumatoid Arthritis Patients: a Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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SP
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Sao Paulo, SP, Brasilien, 04023-900
- Universidade Federal de Sao Paulo
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Rheumatoid arthritis according to American College of Rheumatology 2010
- Both genders
- Age between 18 and 65 years
- Functional class I, II and III
- Stable medication within the three months preceding the study
- Haven't done any kind of regular exercise (two or more times per Week) for at least three months before study start
- Have agreed to participate in the study and signed an informed consent form.
Exclusion Criteria:
- Participating in another type of study
- Have difficulty understanding the evaluation tools with fibromyalgia
- Joint deformities that make impossible do the exercises
- Other musculoskeletal diseases
- Other diseases that contraindicate exercises.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Control group
Patient remain with their usual clinical treatment.
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Andre navne:
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Eksperimentel: Experimental group
Patients in experimental group participated in a 12-week progressive resistance training using a maximum repetition exercise in which patients performed 1 Maximum Repetition with the maximum bearable weight. Once the 1 Maximum Repetitionwas determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1 Maximum Repetition. The exercises were knee extension and flexion and hip abduction and adduction, elbow extension and flexion, wrist extension and flexion and shoulder abduction and adduction and spine extension and flexion all performed in machines. The 1 Maximum Repetition load was reevaluated every 6 weeks. Patient remain with their usual clinical treatment. |
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in pain - Visual analogue scale
Tidsramme: baseline, 6, 12 and 24 weeks
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baseline, 6, 12 and 24 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in function capacity - Health Assessment questionaire
Tidsramme: Baseline, after 6, 12 and 24 weeks
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Baseline, after 6, 12 and 24 weeks
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Change in quality of life - Short form 36
Tidsramme: baseline, after 6, 12 and 24 weeks
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baseline, after 6, 12 and 24 weeks
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Change in strength - 1 maximum repetition
Tidsramme: baseline, after 6, 12 and 24 weeks
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baseline, after 6, 12 and 24 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CEP/UNIFESP 1826/10
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