- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02401958
Acute Effect of Resistance Training in Inflammatory Markers in Women With Rheumatoid Arthritis
16 maj 2016 uppdaterad av: Ana Carolina Pereira Nunes Pinto, Federal University of São Paulo
ABSTRACT Introduction: Rheumatoid arthritis (RA) is a systemic inflammatory, chronic and progressive disease that can lead to joint destruction and important functional disability.
Chronic inflammation, with a substantial increase in the amount of pro-inflammatory cytokines in synovial joint, is one of the biggest challenges in controlling RA.
Resistance exercise has been recognized for positively modulate inflammation in healthy subjects.
Objective: To evaluate the effect of an acute bout of resistance exercise on serum concentrations of tumor necrosis factor alpha (TNF-α), interleukin 1 receptor antagonist(IL-1ra), interleukin 1 beta (IL-1β), C reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), and cartilage oligomeric matrix protein (COMP) in postmenopausal women with RA and women without the disease.
Methods: 17 volunteers with RA and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM.
The exercises performed were: knee extension, knee flexion, hip abduction and hip adduction.
Blood samples were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session.
Serum glucose concentrations prior to exercise were also measured.
The investigators used the Student's't test, the model of analysis of variance with repeated measures and Bonferroni method of multiple comparisons to analyze the data, being considered statistically significant levels of p <0.05.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
34
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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SP
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Sao Paulo, SP, Brasilien, 04023900
- Federal University of São Paulo
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
*Rheumatoid Arthritis Group
Inclusion Criteria:
- Women classified acording to the American College of Rheumatology's criteria to rheumatoid arthritis
- Post menopausal women
- Stable medication three months before study
Exclusion Criteria:
- Women with rheumatoid arthritis with functional class IV, acording to ACR criteria
- Women engaged in some type of regular exercise program;
- Failure: heart, coronary, respiratory, renal and / or hepatic (uncompensated);
- Uncompensated systemic hypertension;
- Volunteers with other associated inflammatory diseases;
Unable to perform the exercises.
- Control group We included in the control group of this study postmenopausal volunteers, without Rheumatoid Arthritis. Exclusion criteria were the same as those adopted for the participants of the Rheumatoid Arthritis Group
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Rheumatoid Arthritis Group
Resistance Training
|
17 volunteers with RA and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM.
The exercises performed were: knee extension, knee flexion, hip abduction and hip adduction.
Blood samples were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session.
|
Aktiv komparator: Healthy control Group
Resistance Training
|
17 volunteers with RA and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM.
The exercises performed were: knee extension, knee flexion, hip abduction and hip adduction.
Blood samples were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in one (or more) of the inflammatory markers
Tidsram: 30 minutes before training; 5 minutes before training; 5 minutes after training; 1 hour after training; 2 hours after training; 24 hours after training
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TNF-alfa, IL1-beta, IL1-ra, PCR, IL10, IL6
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30 minutes before training; 5 minutes before training; 5 minutes after training; 1 hour after training; 2 hours after training; 24 hours after training
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
No change in inflammatory markers
Tidsram: 30 minutes before training; 5 minutes before training; 5 minutes after training; 1 hour after training; 2 hours after training; 24 hours after training
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TNF-alfa, IL1-beta, IL1-ra, PCR, IL10, IL6
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30 minutes before training; 5 minutes before training; 5 minutes after training; 1 hour after training; 2 hours after training; 24 hours after training
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2014
Primärt slutförande (Faktisk)
1 juli 2015
Avslutad studie (Faktisk)
1 augusti 2015
Studieregistreringsdatum
Först inskickad
19 mars 2015
Först inskickad som uppfyllde QC-kriterierna
24 mars 2015
Första postat (Uppskatta)
30 mars 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 maj 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 maj 2016
Senast verifierad
1 maj 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CEP UNIFESP -
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