Yoga And Cardiovascular Health Trial (YACHT)
10. november 2016 oppdatert av: 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.
Studieoversikt
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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London, Storbritannia, W2 1LA
- International Centre for Circulatory Health
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
35 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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 inngripen: Usual care
Usual care (standard cardiac rehabilitation programme) only.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nishi Chaturvedi, Imperial College London
Publikasjoner og nyttige lenker
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Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. juni 2012
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
1. april 2013
Datoer for studieregistrering
Først innsendt
8. mai 2012
Først innsendt som oppfylte QC-kriteriene
14. mai 2012
Først lagt ut (Anslag)
15. mai 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. november 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. november 2016
Sist bekreftet
1. juni 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12/LO/0597
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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