Effectiveness and cost-effectiveness of a Yoga-based Cardiac Rehabilitation (Yoga-CaRe) program following acute myocardial infarction: study rationale and design of a multi-centre randomized controlled trial

© 2019 Background: Cardiac rehabilitation (CR) is a standard treatment for secondary prevention of acute myocardial infarction (AMI) in high income countries (HICs), but it is inaccessible to most patients in India due to high costs and skills required for multidisciplinary CR teams. We developed a low-cost and scalable CR program based on culturally-acceptable practice of yoga (Yoga-CaRe). In this paper, we report the rationale and design for evaluation of its effectiveness and cost-effectiveness. Methods: This is a multi-center, single-blind, two-arm parallel-group randomized controlled trial across 22 cardiac care hospitals in India. Four thousand patients aged 18–80 years with AMI will be recruited and randomized 1:1 to receive Yoga-CaRe program (13 sessions supervised by an instructor and encouragement to self-practice daily) or enhanced standard care (3 sessions of health education) delivered over a period of three months. Participants will be followed 3-monthly till the end of the trial. The co-primary outcomes are a) time to occurrence of first cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and emergency cardiovascular hospitalization), and b) quality of life (Euro-QoL-5L) at 12 weeks. Secondary outcomes include need for revascularization procedures, return to pre-infarct activities, tobacco cessation, medication adherence, and cost-effectiveness of the intervention. Conclusion: This trial will alone contribute >20% participants to existing meta-analyses of randomized trials of CR worldwide. If Yoga-CaRe is found to be effective, it has the potential to save millions of lives and transform care of AMI patients in India and other low and middle income country settings

Yoga-Based Cardiac Rehabilitation After Acute Myocardial Infarction: A Randomized Trial.

BACKGROUND: Given the shortage of cardiac rehabilitation (CR) programs in India and poor uptake worldwide, there is an urgent need to find alternative models of CR that are inexpensive and may offer choice to subgroups with poor uptake (e.g., women and elderly). OBJECTIVES: This study sought to evaluate the effects of yoga-based CR (Yoga-CaRe) on major cardiovascular events and self-rated health in a multicenter randomized controlled trial. METHODS: The trial was conducted in 24 medical centers across India. This study recruited 3,959 patients with acute myocardial infarction with a median and minimum follow-up of 22 and 6 months. Patients were individually randomized to receive either a Yoga-CaRe program (n = 1,970) or enhanced standard care involving educational advice (n = 1,989). The co-primary outcomes were: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the European Quality of Life-5 Dimensions-5 Level visual analogue scale at 12 weeks. RESULTS: MACE occurred in 131 (6.7%) patients in the Yoga-CaRe group and 146 (7.4%) patients in the enhanced standard care group (hazard ratio with Yoga-CaRe: 0.90; 95% confidence interval [CI]: 0.71 to 1.15; p = 0.41). Self-rated health was 77 in Yoga-CaRe and 75.7 in the enhanced standard care group (baseline-adjusted mean difference in favor of Yoga-CaRe: 1.5; 95% CI: 0.5 to 2.5; p = 0.002). The Yoga-CaRe group had greater return to pre-infarct activities, but there was no difference in tobacco cessation or medication adherence between the treatment groups (secondary outcomes). CONCLUSIONS: Yoga-CaRe improved self-rated health and return to pre-infarct activities after acute myocardial infarction, but the trial lacked statistical power to show a difference in MACE. Yoga-CaRe may be an option when conventional CR is unavailable or unacceptable to individuals. (A study on effectiveness of YOGA based cardiac rehabilitation programme in India and United Kingdom; CTRI/2012/02/002408)

Impact of opioid-free analgesia on pain severity and patient satisfaction after discharge from surgery: multispecialty, prospective cohort study in 25 countries

Background: Balancing opioid stewardship and the need for adequate analgesia following discharge after surgery is challenging. This study aimed to compare the outcomes for patients discharged with opioid versus opioid-free analgesia after common surgical procedures.Methods: This international, multicentre, prospective cohort study collected data from patients undergoing common acute and elective general surgical, urological, gynaecological, and orthopaedic procedures. The primary outcomes were patient-reported time in severe pain measured on a numerical analogue scale from 0 to 100% and patient-reported satisfaction with pain relief during the first week following discharge. Data were collected by in-hospital chart review and patient telephone interview 1 week after discharge.Results: The study recruited 4273 patients from 144 centres in 25 countries; 1311 patients (30.7%) were prescribed opioid analgesia at discharge. Patients reported being in severe pain for 10 (i.q.r. 1-30)% of the first week after discharge and rated satisfaction with analgesia as 90 (i.q.r. 80-100) of 100. After adjustment for confounders, opioid analgesia on discharge was independently associated with increased pain severity (risk ratio 1.52, 95% c.i. 1.31 to 1.76; P < 0.001) and re-presentation to healthcare providers owing to side-effects of medication (OR 2.38, 95% c.i. 1.36 to 4.17; P = 0.004), but not with satisfaction with analgesia (beta coefficient 0.92, 95% c.i. -1.52 to 3.36; P = 0.468) compared with opioid-free analgesia. Although opioid prescribing varied greatly between high-income and low- and middle-income countries, patient-reported outcomes did not.Conclusion: Opioid analgesia prescription on surgical discharge is associated with a higher risk of re-presentation owing to side-effects of medication and increased patient-reported pain, but not with changes in patient-reported satisfaction. Opioid-free discharge analgesia should be adopted routinely

CIGR E-Journal Volume 7

Peer Reviewed Original Research Articles --- 1.) A. Tambunan, Y. Sagara, Y. Seo, and Y. Kawagoe. Image Analysis on Temperature Distribution within Lettuce Undergoing Vacuum Cooling. Manuscript FP 04 002. Vol. VII. January 2005. --- 2.) S. Nimmermark and G. Gustafsson. Influence of Temperature, Humidity, and Ventilation Rate on the Release of Odour and Ammonia in a Floor Housing System for Laying Hens. Manuscript BC 04 008. Vol. VII. March 2005. --- 3.) S. Hassan-Beygi and B. Ghobadian. Noise Attenuation Characteristics of Different Road Surfaces During Power Tiller Transport. Manuscript PM 04 009. Vol.VII. March 2005. 4.) L. Pan, P. Shao, and S. Jiang. Separation of Phytosterol and Synthesized VE Succinate from Rapeseed Oil Deodorizer Distillate. Manuscript FP 04 010. March 2005. --- 5.) S. Shrestha, F. Kazama, Y. Sakamoto, and S. Bastola. Statistical Modeling of Pollutant Load in Subbasins of the Fuji River Basin, Japan. Manuscript LW 05 001. Vol. VII. March, 2005. --- 6.) M. Rijo and C. Arranja. Hydraulic Performance of a Downstream Controlled Irrigation Canal Equipped with Different Offtake Types. Manuscript LW 04 014. Vol. VII. March, 2005. --- 7.) J. Krahl, A. Munack, O. Schroeder, H. Stein, L. Herbst, A. Kaufmann, and J. Buenger. Fuel Design as Constructional Element with the Example of Biogenic and Fossil Diesel Fuels. Manuscript EE 04 008. Vol. VII. March, 2005. --- 8.) M. Aradas, I. Naas, and D. Salgado. Comparing the Thermal Environment in Broiler Houses Using Two Bird Densities Under Tropical Conditions. Manuscript BC 03 017. Vol. VII. March, 2005. 9.) N. Kyei-Baffour. The Effect of Quality of Rising Capillary Water on Soil Surface Sodicity. Manuscript LW 04 013. April, 2005. 10.) P. Soni, V. Salokhe, and H. Tantau. Effect of Screen Porosity on Selected Microclimatic Parameters of Naturally Ventilated Tropical Greenhouses. Manuscript BC 05 002. Vol. VII. April, 2005. --- 11.) I. Naas, S. Campos, and K. Silva. Comparison of Manual and Electronic Traceability in Swine Production. Manuscript IT 05 001. Vol. VII. April, 2005. --- 12.) V. Assaad, J. Jofriet, S. Negi, and G. Hayward. Corrosion of Reinforced Concrete Specimens Exposed to Hydrogen Sulfide and Sodium Sulfate. Manuscript BC 03 013. Vol. VII. April, 2005. 13.) S. Sivakumar, R. Manian, K. Kathirvel, and G. Raghavan. Investigation on the Influence of Machine and Operational Parameters for the Development of a Manually-Drawn Rice Seeder for Direct Sowing. Manuscript PM 04 008. Vol. VII. May, 2005. --- 14.) S. Jekayinfa and O. Omisakin. The Energy Potentials of some Agricultural Wastes as Local Fuel Materials in Nigeria. Manuscript EE 05 003. Vol. VII. May, 2005. --- 15.) S. Pedersen, S. Morsing, and J. Strom. Simulation of Heat Requirement and Air Quality in Weaner Houses for Three Climate Regions Using CIGR 2002 Heat Production Equations. Manuscript BC 05 001. Vol. VII. June, 2005. --- 16.) V. Carvalho, I. Naas, M. Mollo, and V. Massafera. Prediction of the Occurrence of Lameness in Dairy Cows using a Fuzzy-Logic Based Expert System??t I. Manuscript IT 05 002. Vol. VII. June, 2005. --- 17.) H. Pandorfi and I. Da Silva. Evaluation of the Behavior of Piglets in Different Heating Systems using Analysis of Image and Electronic Identification. BC 03 021. Vol. VII. August, 2005. 18.) T. Ozturk and M. Bayrakh. The Possibilities of using Tobacco Wastes in Producing Lightweight Concrete. Manuscript BC 05 006. Vol. VII. August, 2005. --- 19.) P. Goodrich, D. Schmidt, and D. Haubenschild. Anaerobic Digestion for Energy and Pollution Control. Manuscript EE 03 001. Vol. VII. August, 2005. --- 20.) W. Lee, J. Schueller, and T. Burks. Wagon-Based Silage Yield Mapping System. Manuscript IT 05 003. Vol. VII. August, 2005. 21.) M. Heinloo, T. Leola, and V. Veinla. Synthesis of the Manipulator for the Scraper of a Press Manure Removal. Manuscript MES 05 002. Vol. VII. August, 2005. --- 22.) T. Tomson and A. Annuk. Wind Energy in Estonian Western Highlands. Manuscript EE 04 001. Vol. VII. September, 2005. --- 23.) G. Bora, M. Schrock, D. Oard, J. Grimm, and T. Kolb. Performance of a Stacked Valve Multipoint Pulse Width Modulation (PWM) Manifold for Variable Rate Anhydrous Ammonia Application. Manuscript PM 05 005. Vol.VII. September, 2005. --- 24.) E. Quendler, P. Veith, A. Pohl, and J. Boxberger. More Security for Kids Around Moving Vehicles on Farms. Manuscript SAFETY 05 001. Vol. VII. September, 2005. --- 25.) M. Queiroz, I. Naas, C. Sampaio. Estimating Thermal Comfort for Piglets Considering Ammonia Concentration. Manuscript IT 05 004/BC 05 005. Vol. VII. September, 2005. --- 26.) S. Ojolo and A. Bamgboye. Thermochemical Conversion of Municipal Solid Waste to Produce Fuel and Reduce Waste. Manuscript EE 05 006. Vol. VII. September, 2005. --- 27.) Y. Mijinyawa and J. Adetunji. Evaluation of Farm Transportation System in Osun and Oyo States of Nigeria. Manuscript LW 05 004. Vol. VII. September, 2005. --- 28.) S. Morsing, S. Pedersen, J. Strom, and L. Jacobsen. Energy Consumption and Air Quality in Growing-Finishing Pig Houses for Three Climate Regions Using CIGR 2002 Heat Production Equations. Manuscript BC 05 007. Vol. VII. September, 2005. --- 29.) R. Schmersahl and V. Scholz. Testing a PEM Fuel Cell System with Biogas Fuel. Manuscript EE 05 002. Vol. VII. September, 2005. --- 30.) U. Mutwiwa and H. Tantau. Suitability of a UV Lamp for Trapping the Greenhouse Whitefly Trialeurodes vaporariorum Westwood (Hom: Aleyrodidae). Manuscript BC 05 004. Vol. VII. September, 2005. --- 31.) S. Kazemi, N. Wang, M. Ngadi, and S. Prasher. Evaluation of Frying Oil Quality Using VIS/NIR Hyperspectral Analysis. Manuscript FP 05 001. Vol. VII. September, 2005. --- 32.) W. Reimann. Down Streaming of Lactic Acid from Hydrolysate of Barley after Fermentation. Manuscript FP 05 004. Vol. VII. September, 2005. --- 33.) B. Sarkar and G. Tiwari. Thermal Modeling of a Greenhouse Fish Pond System. Manuscript BC 05 015. Vol. VII. October, 2005. 34.) S. Ido and M. Bux. Prediction of Evaporation Rate in a Solar Dryer for Sewage Sludge. Manuscript EE 05 009. Vol. VII. October, 2005. --- 35.) U. Dhakal, V. Salokhe, H. Tantau, and J. Max. Development of a Greenhouse Nutrient Recycling System for Tomato Production in the Humid Tropics. Manuscript BC 05 008. Vol. VII. October, 2005. --- 36.) E. Ajav and B. Adejumo. Performance Evaluation of an Okra Thresher. Manuscript PM 04 006. Vol. VII. October, 2005. --- 37.) K. Patil, T. Bowser, D. Bellmer, and R. Huhnke. Fluidization Characteristics of Sand and Chopped Switchgrass-Sand Mixtures. Manuscript EE 04 005. Vol. VII. October, 2005. --- 38.) S. Al-Kufaishi, S. Blackmore, H. Sourell, and G. Maletti. Assessment of Two Variable Rate Irrigation Controllers used on a Centre-Pivot. Manuscript LW 05 002. Vol. VII. October, 2005. --- 39.) P. Maly, T. Hoffman, and Ch. Furll. Gentle Harvest of Potatoes in Storage Boxes. Manuscript FP 05 002. Vol. VII. October, 2005. --- 40.) M. Reza Ehsani, C. Divaker Durairaj, S. Woods, and M. Sullivan. Potential Application of Electrical Conductivity(EC) Map for Variable Rate Seeding. Manuscript IT 05 006. Vol. VII. November, 2005. --- 41.) O. Kitani, K. Roy, M. Yoshida, and R. Endo. Control of Water Environment of Plants using Waste Biomass. Manuscript LW 05 007. Vol. VII. November, 2005. --- 42.) J. Hou, Y. Qian, G. Lui, and R. Dong. The Influence of Temperature, pH, and C/N Ratio on the Growth and Survival of Earthworms in Municipal Solid Waste. Manuscript FP 04 014. Vol VII. November, 2005. --- 43.) G. Gustafsson, K-H. Jeppsson, J. Hultgren, and J-O. Sanno. Techniques to Reduce the Ammonia Release from a Cowshed with Tied Dairy Cattle. Manuscript BC 04 010. Vol. VII. November, 2005. --- 44.) K. Hassenberg and Chr. Idler. Influence of Washing Method on the Quality of Prepacked Iceberg Lettuce. Manuscript FP 05 003. Vol. VII. November, 2005. --- 45.) E. Mamman and K. Oni. Draught Performance of a Range of Model Chisel Furrowers. Manuscript PM 05 003. Vol. VII. November, 2005. --- 46.) E. Mamman, B. Umar, and N. Aviara. Effect of Moisture Content and Loading Orientation on the Mechanical Properties of Balanites Aegyptiaca Nuts. Manuscript FP 04 015. Vol. VII. December, 2005. --- 47.) Y. Yiljep, G. Fumen, and E. Ajisegiri. The Effects of Peeling, Splitting and Drying on Ginger Quality and Oil/oleoresin Content. Manuscript FP 05 009. Vol. VII. December, 2005. --- 48.) Y. Yiljep and U. Mohammed. Effect of Knife Velocity on Cutting Energy and Efficiency during Impact Cutting of Sorghum Stalk. Manuscript PM 05 004. Vol. VII. December, 2005. --- 49.) G. Gustafsson and E. von Wachenfelt. Measures against Ammonia Release in a Floor Housing System for Laying Hens. Manuscript BC 05 003. Vol. VII. December, 2005. --- 50.) A. Prochnow, M. Heiermann, A. Drenckhan, and H. Schelle. Seasonal Pattern of Biomethanisation of Grass from Landscape Managemant. Manuscript EE 05 011. Vol. VII. December, 2005. --- 51.) A. Wagner and W. Buescher. Compression Characteristics of Wilted Grass. Manuscript IT 05 007. Vol. VII. December, 2005. --- 52.) H. Kushwaha, A. Srivastava, and H. Singh. Development and Performance Evaluation of an Okra Seed Extractor. Manuscript PM 05 001. Vol. VII. December, 2005. ---- 53.) P. Mahnert, M. Heiermann, and B. Linke. Batch- and Semicontinuous Biogas Production from Different Grass Species. Manuscript EE 05 010. Vol. VII. December, 2005. --- Invited Overview Articles --- 1.) L. Pereira. Water and Agriculture: Facing Water Scarcity and Environmental Challenges. Invited Overview. Vol. VII. February 2005. --- 2.) A. Raji and A. Olamutu. Prospects of Computer Vision Automated Sorting Systems in Agricultural Process Operations in Nigeria. Invited Overview. Vol. VII. February 2005. --- 3.) J. Yuan. The Status of China's Agricultural Machinery Industry and the Prospects for International Cooperation. Invited Overview. Club of Bologna. Vol. VII. March, 2005. --- 4.) S. Li. Agricultural Mechanization Promotion in China-Current Situation and Future. Invited Overview. Club of Bologna. Vol. VII. March, 2005. --- 5.) G. Gavioli. Cost Benefits of the Platform Principles for Tractors and Other Agricultural Machinery. Invited Overview. Club of Bologna. Vol. VII. March, 2005. --- 6.) G. Gavioli. Cost Benefits of the Platform Principles for Tractors and Other Agricultural Machinery. Invited Overview. Power Point Slides. Club of Bologna. Vol. VII. March, 2005. --- 7.) A. Segre and H. Petrics. EU Enlargement and its Influence on Agriculture and Mechanisation. Invited Overview. Club of Bologna. Vol. VII. March, 2005. --- 8.) E. Gasparetto. Conclusions and recommendations. Invited Overview. Club of Bologna. Vol. VII. March, 2005. --- 9.) J. Ullman. Remedial Activities to Reduce Atmospheric Pollutants from Animal Feeding Operations. Invited Overview. Vol. VII. June, 2005. --- 10.) Y. Mijinyawa. Agricultural Engineering Education in Nigeria. Invited Overview. Vol. VII. August. 2005