- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01597960
Yoga And Cardiovascular Health Trial (YACHT)
10. november 2016 opdateret af: Imperial College London
The benefits of alternative therapeutic approaches, such as yoga, are poorly understood and this is particularly true of the beneficial effects on cardiovascular disease (CVD) risk.
It is hoped that a better understanding of the value of this therapy will provide a sound scientific basis for including yoga in mainstream clinical practice.
The investigators propose to study a group of 80 participants (40 Indian Asians and 40 Europeans) recruited from a cardiac rehabilitation programme in West London post-angioplasty as treatment for an acute coronary syndrome.
Those who agree will undergo a series of baseline and follow-up measurements.
20 Indian Asians and 20 Europeans will be randomized to the yoga intervention plus their standard cardiac rehabilitation programme (usual care), and the remaining 20 Indian Asians and 20 Europeans will be randomized to usual care alone.
Baseline and follow-up measurements will be performed on all participants.
In order to determine the acute effects of yoga the group randomised to the yoga intervention will also undergo a series of acute tests before and after their first yoga session.
Studieoversigt
Detaljeret beskrivelse
The benefits of alternative therapeutic approaches, such as yoga, are poorly understood and this is particularly true of the beneficial effects on cardiovascular disease (CVD) risk.
It is hoped that a better understanding of the value of this therapy will provide a sound scientific basis for including yoga in mainstream clinical practice.
The investigators propose to study a group of 80 participants (40 Indian Asians and 40 Europeans) recruited from a cardiac rehabilitation programme in West London post-angioplasty as treatment for an acute coronary syndrome.
Those who agree will undergo a series of baseline and follow-up measurements.
20 Indian Asians and 20 Europeans will be randomized to the yoga intervention plus their standard cardiac rehabilitation programme (usual care), and the remaining 20 Indian Asians and 20 Europeans will be randomized to usual care alone.
Baseline and follow-up measurements will be performed on all participants; these include: Demographic & health questionnaire, Lifestyle questionnaires focusing on diet and exercise, Fasting bloods sampling (for cardiovascular risk factors and markers), Saliva sampling (x 5 samples for salivary cortisol and alpha-amylase), Anthropometrics - height, weight and waist and hip circumference, Bioimpedence - measurement of total body fat, 3D and Doppler echocardiography, Carotid IMT, Resting brachial blood pressure, Central blood pressure (tonometery at the radial artery), Pulse Wave Velocity, 12 lead ECG, Cardiopulmonary exercise testing, Combined 24hr BP & ECG monitor, Accelerometer (3 days).
In order to determine the acute effects of yoga the group randomised to the yoga intervention will also undergo a series of acute tests before and after their first yoga session.
These include: Exercise capacity, Saliva sampling (x 5 samples for salivary cortisol and alpha-amylase) and combined 24hr BP & ECG monitor.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
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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London, Det Forenede Kongerige, W2 1LA
- International Centre for Circulatory Health
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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
35 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Aged 35-80 years.
- Male or female.
- European or Indian Asian descent.
- Able to understand English or Punjabi.
- Referred to a cardiac rehabilitation programme in West London post-angioplasty as treatment for an acute coronary syndrome.
Exclusion Criteria:
- Adults under 35 years or above 80 years.
- Adults aged 35-80 years who are not competent to give consent.
- Co-morbid disease or mobility limitations that would preclude participation in cardiac rehabilitation and our investigations.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Yoga 12 week programme
Usual care (standard cardiac rehabilitation programme) plus yoga intervention.
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Those randomised to usual care plus the yoga intervention will be required to attend yoga classes twice a week for 12 weeks alongside their cardiac rehabilitation programme.
There will be 24 yoga classes in total, of which, we require the participant to attend a minimum of 18.
The yoga classes will be conducted by a teacher certified in yoga and cardiac rehabilitation and will encompass physical fitness (yoga poses), stress reduction (breath control and meditation) and positive lifestyle changes (diet, smoking and alcohol).
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Ingen indgriben: Usual care
Usual care (standard cardiac rehabilitation programme) only.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cardiopulmonary function
Tidsramme: Week 0 (pre intervention) and week 12 (post intervention)
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To perform a mechanistic study that determines the acute and chronic effects of yoga on cardiopulmonary function, autonomic function, blood pressure and heart rate.
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Week 0 (pre intervention) and week 12 (post intervention)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Blood pressure
Tidsramme: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Blood pressure will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
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Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Heart rate and heart rate variability
Tidsramme: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Heart rate and heart rate variability will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
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Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Stress hormones
Tidsramme: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Stress hormones will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
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Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Exercise capacity
Tidsramme: Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Exercise capacity will be measured at baseline, at the beginning and end of the first yoga class, and immediately after the 12 week intervention.
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Week 0 (pre intervention), week 1 (pre & post 1st yoga class), and week 12 (post intervention)
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Body fat
Tidsramme: Week 0 (pre intervention) and week 12 (post intervention)
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Body fat will be measured at baseline and immediately after the 12 week intervention.
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Week 0 (pre intervention) and week 12 (post intervention)
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Glucose and lipids
Tidsramme: Week 0 (pre intervention) and week 12 (post intervention)
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Glucose and lipids will be measured at baseline and immediately after the 12 week intervention.
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Week 0 (pre intervention) and week 12 (post intervention)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nishi Chaturvedi, Imperial College London
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. juni 2012
Primær færdiggørelse (Faktiske)
1. april 2013
Studieafslutning (Faktiske)
1. april 2013
Datoer for studieregistrering
Først indsendt
8. maj 2012
Først indsendt, der opfyldte QC-kriterier
14. maj 2012
Først opslået (Skøn)
15. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. november 2016
Sidst verificeret
1. juni 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12/LO/0597
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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 .
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