- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02400515
Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic Individuals
23. marts 2015 opdateret af: Andrea Sanches, University of Campinas, Brazil
Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic and Hypertensive Individuals
This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on glucose and lipid metabolism as well as the scales of anxiety and depression and levels of salivary cortisol in women with type 2 diabetes.
Studieoversigt
Detaljeret beskrivelse
This quasi-experimental study aim to performed a 12-week training program (3 times/week, 60 minutes per session) which consisted of a supervised moderate aerobic exercise previously determined (50% to 70% of maximal Heart Rate) in women with type 2 diabetes.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
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
40 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- having normal physical examinations,
- no participation in regular, moderate or intensive exercise for at least 6 months before the study and
- not be following a diet
Exclusion Criteria:
- the use of insulin and beta-blocker medications and
- the functional inability to perform exercise
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Moderate Exercise
Aerobic physical exercise was applied during 3 months, 3x/week on women with type 2 diabetic.
The evaluation occurred before and after exercise in the same (and only) group, considering that this is a quasi-experimental study.
|
This is a quasi-experimental study and the same group was evaluated before and after the exercise.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Glucose levels
Tidsramme: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glucose test.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Systolic and Diastolic blood pressure
Tidsramme: 3 months
|
Change in Systolic and Diastolic blood pressure were evaluated before and after physical exercise, during 3 months.
|
3 months
|
|
Heart Rate measurement
Tidsramme: 3 months
|
Change in heart rate was evaluated before, during and after physical exercise, during 3 months.
|
3 months
|
|
Glycated hemoglobin levels
Tidsramme: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Glycated hemoglobin test.
|
3 months
|
|
Proteinuria levels
Tidsramme: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for proteinuria test.
|
3 months
|
|
Triglycerides levels
Tidsramme: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for triglycerides test.
|
3 months
|
|
High Density Level (HDL) Cholesterol levels
Tidsramme: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for High Density Level Cholesterol test.
|
3 months
|
|
Low Density Level (LDL) Cholesterol levels
Tidsramme: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new collection of blood for Low Density Level Cholesterol test.
|
3 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Salivary cortisol
Tidsramme: 3 months
|
After practicing the exercise for 3 months, patients were submitted to a new saliva collection for the salivary cortisol measure.
|
3 months
|
|
Hospital Anxiety and Depression scale (HADS)
Tidsramme: 3 months
|
After 3 months of the physical exercise, the HADS was evaluated.
|
3 months
|
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
1. august 2007
Primær færdiggørelse (Faktiske)
1. marts 2008
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
5. marts 2015
Først indsendt, der opfyldte QC-kriterier
23. marts 2015
Først opslået (Skøn)
27. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. marts 2015
Sidst verificeret
1. marts 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 030/2007
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Diabetes mellitus, type 2
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