Yoga And Cardiovascular Health Trial (YACHT)
10 november 2016 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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London, Verenigd Koninkrijk, W2 1LA
- International Centre for Circulatory Health
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
35 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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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Geen tussenkomst: Usual care
Usual care (standard cardiac rehabilitation programme) only.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Cardiopulmonary function
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Blood pressure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nishi Chaturvedi, Imperial College London
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2012
Primaire voltooiing (Werkelijk)
1 april 2013
Studie voltooiing (Werkelijk)
1 april 2013
Studieregistratiedata
Eerst ingediend
8 mei 2012
Eerst ingediend dat voldeed aan de QC-criteria
14 mei 2012
Eerst geplaatst (Schatting)
15 mei 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
11 november 2016
Laatste update ingediend die voldeed aan QC-criteria
10 november 2016
Laatst geverifieerd
1 juni 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12/LO/0597
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
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