Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension
8. januar 2013 opdateret af: Marshall Hagins, Long Island University
The proposed study will compare a well defined and integrated yoga practice (postures/breath control/meditation) to a conventional exercise program in reducing hypertension.
The expected outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial stress, and the autonomic system in individuals with pre- and Stage I hypertension.
The information gained in this study will have a positive impact by providing critical preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial on the effects of yoga on individuals with hypertension.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
Brooklyn, New York, Forenede Stater, 11201
- Long Island University
-
-
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
21 år til 74 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age: 21-64; Pre- or Stage I hypertension with mean office blood pressure (two measurements using aneroid sphygmomanometer) of systolic between 120 and 159 mmHg or Diastolic between less than or equal to 80 and 99 [1]
- Medically stable on any current medications; BMI (kg/m2) between 18.5 - 40
- English speaking
Exclusion Criteria:
- Taking anti-hypertensive medication; Current use of insulin or oral hypoglycemic agents
- Previous cardiovascular event (prior myocardial infarction, stroke, or angina pectoris)
- Current or previous cancer diagnosis
- Congestive heart failure
- History of kidney disease
- Signs or symptoms of significant peripheral vascular disease
- Significant co-morbidities that preclude successful completion of the study
- Yoga practitioner (participated in more than 3 yoga sessions within the last year)
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Yoga
The integrated yoga program was designed to: 1) include the three primary elements of yoga as most commonly practiced in western cultures (physical postures, breath control and meditation); and 2) be appropriate for those without any prior yoga experience and with pre- and Stage I hypertension.
The yoga program was designed by Eddie Stern, Founder and Director of "Ashtanga Yoga New York" (AYNY) in consultation with Drs.
Hagins and Rundle, and are in large part congruent with the yoga program we studied previously (see Preliminary Studies).
The yoga class includes: instruction on yogic principles regarding moral precepts (yamas and niyamas); active postures requiring mild-moderate physical exertion; conscious control of the breath in synchrony with active postures; and meditation.
We expect approximately 10-15 minutes of the integrated yoga program to consist of isolated practice of meditation (occurring independently of the moving postures, typically in seated or lying positions).
|
breathing, meditation, physical postures
|
|
Aktiv komparator: Conventional Exercise
Conventional exercise such as standing toe touch with arm swings, curl ups, push ups, leg lifts, etc.
All done at a relatively slow rate which will be non-aerobic and at an average rate across the session of 3 METs
|
Standard physical exercises such as toe touch in standing, curl ups, push ups, leg lifts
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ambulatory Blood Pressure
Tidsramme: Assessed within one week post a 12 week intervention
|
24 hour ambulatory blood pressure: systolic, diastolic
|
Assessed within one week post a 12 week intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Psychosocial Stress
Tidsramme: Assessed within one week after 12 week intervention
|
perceived stress, coping, tolerance of uncertainty, sense of control,
|
Assessed within one week after 12 week intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Marshall A Hagins, PhD, PT, Long Island University
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. september 2011
Primær færdiggørelse (Faktiske)
1. oktober 2012
Studieafslutning (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først indsendt
19. februar 2012
Først indsendt, der opfyldte QC-kriterier
25. februar 2012
Først opslået (Skøn)
2. marts 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. januar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. januar 2013
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1SC3GM088049-01A1 REVISED
- 1SC3GM088049-01A1 (U.S. NIH-bevilling/kontrakt)
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 .