- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03684330
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
Intervention / Behandling
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
-
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Pernambuco
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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
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03 måneders WBV-træning tre gange om ugen
a dose once a week
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Placebo komparator: Vitamin D placebo
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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
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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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- croninflam
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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