Yoga And Cardiovascular Health Trial (YACHT)
10 november 2016 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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London, Storbritannien, W2 1LA
- International Centre for Circulatory Health
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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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Inget ingripande: Usual care
Usual care (standard cardiac rehabilitation programme) only.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Cardiopulmonary function
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Nishi Chaturvedi, Imperial College London
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2012
Primärt slutförande (Faktisk)
1 april 2013
Avslutad studie (Faktisk)
1 april 2013
Studieregistreringsdatum
Först inskickad
8 maj 2012
Först inskickad som uppfyllde QC-kriterierna
14 maj 2012
Första postat (Uppskatta)
15 maj 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 november 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 november 2016
Senast verifierad
1 juni 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12/LO/0597
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
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