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Vitamin D Supplementation and WBV in Inflammatory Markers, Strength and Body Composition in Old Patients With COPD

24. september 2018 opdateret af: Maíra F Pessoa

Efficacy of Vitamin D Supplementation Added to WBV Chronic Protocol in Inflammatory Markers, Peripheral and Respiratory Strength and Body Composition in Old Patients With COPD

Verify the influence off vitamin D supplementation and a whole body vibration (WBV) protocol during 03 months in older patients chronic obstructive pulmonary disease

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

59

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pernambuco
      • Recife, Pernambuco, Brasilien, 50740-560
        • UFPE

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

60 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Older patients with COPD
  • Both genders
  • Sedentary according to International Physical Activity Questionnaire (IPAQ) short form
  • BMI in between 22.9 and 28 kg/m2.
  • Older patients with COPD should have a clinical-functional diagnosis of the disease according to GOLD (GOLD, 2018), have been ex-smokers and have not used corticosteroids or have used this drug in a stable way for at least one year (without dosage or medication modifications).
  • Older volunteers should be self-referenced healthy or, if they had systemic arterial hypertension or diabetes mellitus, these comorbidities should be controlled by diet or regular medication use.

Exclusion Criteria:

  • Older patients with COPD who had episodes of exacerbation in the last three months, those with pulmonary rehabilitation programs in the last year, those who used home oxygen therapy, and patients with COPD associated comorbidities were excluded.
  • Volunteers of both groups who were taking vitamin D were excluded, as well as the current smokers, although occasional, volunteers with a history of labyrinthitis or thromboembolism, who had undergone surgical procedures of any size in the last year, such as plaques, pins or cardiac pacemakers, those with unconsolidated fractures that used medications that affected bone metabolism or lean mass, or those who had difficulties adapting to the assessment or the training protocol.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Vitamin D supplementation
03 måneders WBV-træning tre gange om ugen
a dose once a week
Placebo komparator: Vitamin D placebo
03 måneders WBV-træning tre gange om ugen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
serum inflammatory marker Interleukine-6 (IL-6)
Tidsramme: before and immediately up to 12 weeks in WBV training.
changes in total serum values of interleukine 6
before and immediately up to 12 weeks in WBV training.
serum inflammatory marker Interleukine-8 (IL-8)
Tidsramme: before and immediately up to 12 weeks in WBV training.
changes in total serum values of interleukine 8
before and immediately up to 12 weeks in WBV training.
serum inflammatory marker TNF-alpha ( and BDNF)
Tidsramme: before and immediately up to 12 weeks in WBV training.
changes in total serum values of tumoral necrose factor alpha
before and immediately up to 12 weeks in WBV training.
serum inflammatory marker and brain derived neurotrophic factor (BDNF)
Tidsramme: before and immediately up to 12 weeks in WBV training.
changes in total serum values of brain derived neurotrophic factor
before and immediately up to 12 weeks in WBV training.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peripheral strength
Tidsramme: before and immediately up to 12 weeks in WBV training.
Changes in Peripheral muscle strength assessed by the hand dynamometer (device that assess strength) in values obtained from the mean of 03 maneuvers of isokinetic contraction, in centimeters of water
before and immediately up to 12 weeks in WBV training.
Body composition
Tidsramme: before and immediately up to 12 weeks in WBV training.
Changes in electrical bioimpedance assessing lean mass in segmental areas and trunk
before and immediately up to 12 weeks in WBV training.
Respiratory strength
Tidsramme: before and immediately up to 12 weeks in WBV training.
Changes in respiratory strength obtained from a manovacuometer, collecting the major value of 03 maneuvers of the maximal inspiration (vacuometer) to the maximal expiration pressures (manometer), with values obtained in centimeters of water
before and immediately up to 12 weeks in WBV training.

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)

20. maj 2018

Primær færdiggørelse (Faktiske)

30. august 2018

Studieafslutning (Forventet)

30. september 2018

Datoer for studieregistrering

Først indsendt

22. september 2018

Først indsendt, der opfyldte QC-kriterier

24. september 2018

Først opslået (Faktiske)

25. september 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • croninflam

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Kliniske forsøg med helkropsvibration (WBV)

3
Abonner