Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus: A Randomized Clinical Trial
Circulation. Cardiovascular quality and outcomes. 2019;(9):e005805
BACKGROUND Mobile health interventions may support risk factor management and are readily scalable in healthcare systems. We aim to evaluate the efficacy of a text messaging-based intervention to improve glycemic control in patients with coronary heart disease and diabetes mellitus in China. METHODS AND RESULTS The CHAT-DM study (Cardiovascular Health and Texting-Diabetes Mellitus) was a parallel-group, single-blind, randomized clinical trial that included 502 patients with both coronary heart disease and diabetes mellitus from 34 hospitals in China. The intervention group (n=251) received 6 text messages per week for 6 months in addition to usual care. Messages were theory driven and culturally tailored to provide educational and motivational information on glucose monitoring, blood pressure control, medication adherence, physical activity, and lifestyle. The control group (n=251) received usual care and 2 thank you messages per month. The primary outcome was change in glycated hemoglobin (HbA1C [hemoglobin A1C]) from baseline to 6 months. Secondary outcomes were change in proportion of patients achieving HbA1C <7%, fasting blood glucose, systolic blood pressure, LDL (low-density lipoprotein) cholesterol, body mass index, and physical activity from baseline to 6 months. The end points were assessed using analyses of covariance. The follow-up rate was 99%. When compared with control group at 6 months, the intervention group had a greater reduction in HbA1C (-0.2% versus 0.1%; P=0.003) and a greater proportion of participants who achieved HbA1C <7% (69.3% versus 52.6%; P=0.004). Change in fasting blood glucose was larger in the intervention group (between-group difference: -0.6 mmol/L; 95% CI, -1.1 to -0.2; P=0.011), but no other outcome differences were observed. Nearly all participants reported that messages were easy to understand (97.1%) and useful (94.1%). CONCLUSIONS A text message intervention resulted in better glycemic control in patients with diabetes mellitus and coronary heart disease. While the mechanism of this benefit remains to be determined, the results suggest that a simple, culturally sensitive mobile text messaging program may provide an effective and feasible way to improve disease self-management. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT02883842.
Genetic Susceptibility, Dietary Protein Intake, and Changes of Blood Pressure: The POUNDS Lost Trial.
Hypertension (Dallas, Tex. : 1979). 2019;(6):1460-1467
High blood pressure (BP) is closely related to obesity, and weight loss lowers BP. Evidence has shown considerable interpersonal variation of changes in BP among people experiencing weight loss, and such variation might be partly determined by genetic factors. We assessed the changes in systolic and diastolic BP (SBP/DBP) among 692 participants randomly assigned to 1 of 4 diets varying in macronutrient content for 2 years. Two separate polygenic scores (SBP/DBP-PGS derived from 52/50 single nucleotide polymorphisms) were built for each participant based on 66 BP-associated single nucleotide polymorphisms. During a 2-year intervention, participants in the bottom versus upper tertile of SBP/DBP-PGS had a greater decrease in SBP (△SBP at 6, 12, and 24 months: -3.84 versus -1.61, -4.76 versus -2.75, -2.49 versus -1.63; P=0.001) or in DBP (△DBP at 6, 12, and 24 months: -3.09 versus -1.34, -2.69 versus -1.44, -1.82 versus -0.53; P<0.001). We also found gene-diet interaction on changes in SBP from baseline to 24 months (Pinteraction=0.009). Among participants assigned to a high-protein diet, those with a lower SBP-polygenic scores had greater decreases in SBP at months 6 (P=0.018), months 12 (P=0.007), and months 24 (P=0.089); while no significant difference was observed across the SBP-polygenic scores tertile groups among those assigned to an average-protein diet (all P values >0.05). Our data indicate that genetic susceptibility may affect BP changes in response to weight-loss diet interventions, and protein intake may modify the genetic associations with changes in BP. This trial was registered at URL: http://www.clinicaltrials.gov. Unique identifier: NCT00072995.
Effects of Progressive Upper Limb Exercises and Muscle Relaxation Training on Upper Limb Function and Health-Related Quality of Life Following Surgery in Women with Breast Cancer: A Clinical Randomized Controlled Trial.
Annals of surgical oncology. 2019;(7):2156-2165
OBJECTIVE The aim of this study was to examine the effects of progressive upper limb exercises and muscle relaxation training (PULE-MRT) on upper limb function and health-related quality of life (HRQoL) following surgery in Chinese mainland women with breast cancer (BC). METHODS Overall, 102 patients following surgery (i.e. mastectomy or breast-conserving surgery, with sentinel lymph node biopsy or axillary lymph node dissection) were randomly allocated to the intervention (n = 51) or control (n = 51) groups. The former received PULE-MRT plus routine nursing care, whereas the latter received only routine nursing care for 6 months. Upper limb function and HRQoL were measured at baseline and 1, 3, and 6 months using Constant-Murley scores (CMS) and Functional Assessment of Cancer Therapy-Breast version 4.0 (FACT-Bv4.0), respectively. RESULTS All patients in the intervention group completed the exercises and training, with 100% compliance and no adverse events. The intervention group had significantly higher total CMS and FACT-Bv4.0 scores at 1-, 3-, and 6-month follow-up than the control group. The significant effects in total CMS comparisons were group (F = 25.30, p < 0.001), time (F = 18.02, p < 0.001), and group-by-time interaction (F = 9.95, p < 0.001), and, in FACT-Bv4.0, total score comparisons were group (F = 15.87, p < 0.001), time (F = 17.92, p < 0.001), and group-by-time interaction (F = 7.88, p < 0.001). Similar results were observed for the scale scores of CMS and FACT-Bv4.0. CONCLUSIONS PULE-MRT had positive effects on improving upper limb function and HRQoL following surgery in women with BC and could be used as an optional rehabilitation management strategy in post-surgery BC patient populations. Trial Registration ChiCTR-IOR-16008253 (Chictr.org.cn; 9 April 2016).
Effects of home-based cardiac exercise rehabilitation with remote electrocardiogram monitoring in patients with chronic heart failure: a study protocol for a randomised controlled trial.
BMJ open. 2019;(3):e023923
INTRODUCTION Patients with chronic heart failure (CHF) can benefit from exercise rehabilitation (ER) with significant improvements in exercise capacity, quality of life and reduction in hospitalisations. Despite its reported benefits, only a small number of patients with CHF attend ER due to poor adherence, and improper exercise may even lead to adverse events. Remote ECG monitoring system (REMS) has the potential to overcome these obstacles. We hypothesise that home-based cardiac ER using REMS in CHF patients is effective compared with conventional ER without monitoring. METHODS AND ANALYSIS This study is a prospective, randomised, parallel controlled clinical trial designed to evaluate the effectiveness of home-based phase-II ER with REMS in the treatment of CHF with a target enrolment of 120 patients (left ventricular ejection fraction <50%, New York Heart Association (NYHA) classes I to III). Patients are randomised to either REMS rehabilitation group or conventional rehabilitation group in a 1:1 ratio. All patients start an exercise training in a supervised setting and then transition to a home-based regimen. The supervised training phase consists of 12 supervised training sessions, three sessions per week for 4 weeks. During the home exercise phase, patients exercise five times per week for 8 weeks. In the REMS group, patients wear monitors during exercise to ensure that exercise intensity is within the set ranges. REMS will also detect risky arrhythmia and alert the patients and their doctors on time. The training intensity is not monitored in the conventional rehabilitation group. The primary outcome is exercise capacity improvement measured by peak oxygen uptake (VO2 peak) (baseline vs 3 m). Secondary outcomes include 6-min walk test, NYHA classes, echocardiographic parameters, cardiac biomarkers, major adverse cardiovascular events, quality of life, psychological well-being and patients' adherence to the rehabilitation programme. ETHICS AND DISSEMINATION This study was approved by Ethics Committee of China-Japan Friendship Hospital for Clinical Research (No. 2018-55 K39). The results of this study will be disseminated via peer-reviewed publications and presentations at conferences. TRIAL REGISTRATION NUMBER ChiCTR-RNR-17012446; Pre-results.
The Dynamic Interplay between the Gut Microbiota and Autoimmune Diseases.
Journal of immunology research. 2019;2019:7546047
Plain language summary
The human gut, or intestines, are populated with commensal bacteria which live in harmony with us and support various biological functions. The main role of the gut microbiota is to maintain the homeostasis of our immune system. It does this by maintaining the integrity of the intestinal lining and helping with digestive processes, production, and absorption of nutrients, and harvesting of immune cells. Our gut microbiome develops throughout infancy and confers benefits in adulthood and so any disruption to its development may impact on health. An imbalance between these helpful bacteria and more harmful pathogenic bacteria, which are also present in smaller amounts, is called dysbiosis and is a common factor in many autoimmune conditions. Autoimmune conditions are characterised by an over-active immune system where immune cells attack our own body. Imbalances in gut microbiota are also common, and diet is thought to be a key factor alongside other genetic and environmental factors. Evidence suggests that long-term dysbiosis may trigger autoimmune disease, amplify disease progression or both, as seen in studies on Arthritis, Lupus, Inflammatory bowel disease. The gut microbiota can be partially restored and supported with antimicrobial interventions, prebiotics, and selective probiotics. The review concludes that therapies targeting the gut microbiota may be eﬀective in the future prevention or treatment of autoimmune diseases.
The human gut-resident commensal microbiota is a unique ecosystem associated with various bodily functions, especially immunity. Gut microbiota dysbiosis plays a crucial role in autoimmune disease pathogenesis as well as in bowel-related diseases. However, the role of the gut microbiota, which causes or influences systemic immunity in autoimmune diseases, remains elusive. Aryl hydrocarbon receptor, a ligand-activated transcription factor, is a master moderator of host-microbiota interactions because it shapes the immune system and impacts host metabolism. In addition, treatment optimization while minimizing potential adverse effects in autoimmune diseases remains essential, and modulation of the gut microbiota constitutes a potential clinical therapy. Here, we present evidence linking gut microbiota dysbiosis with autoimmune mechanisms involved in disease development to identify future effective approaches based on the gut microbiota for preventing autoimmune diseases.
Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial
Circulation. Cardiovascular quality and outcomes. 2019;(4):e005616
BACKGROUND Mobile health technologies are low cost, scalable interventions with the potential to promote patient engagement and behavior change. We aimed to test whether a culturally sensitive text messaging intervention supporting secondary prevention improves the control of risk factors in patients with coronary heart disease in China. METHODS AND RESULTS In this multicenter, single-blinded randomized controlled trial, 822 patients (mean age, 56.4 [SD, 9.5] years; 14.1% women) with coronary heart disease and without diabetes mellitus from 37 hospitals in China were enrolled between August 2016 and March 2017. In addition to usual care, the control group (n=411) received 2 thank you messages/month; the intervention group (n=411) received 6 text messages/week for 6 months delivered by an automated computerized system. The messages provided educational and motivational information related to disease-specific knowledge, risk factor control, physical activity, and medication adherence. The primary end point was change in systolic blood pressure from baseline to 6 months. Secondary end points included the proportion with systolic blood pressure <140 mm Hg, smoking status, and change in body mass index, LDL-C (low-density lipoprotein cholesterol), and physical activity (assessed using the International Physical Activity Questionnaire). The end points were assessed using analyses of covariance. Follow-up was 99.6%. At 6 months, systolic blood pressure was not significantly lower in the intervention group compared with the control group, with a mean change (SD) of 3.2 (14.3) mm Hg and 2.0 (15.0) mm Hg ( P>0.05) from baseline, respectively (mean net change, -1.3 mm Hg [95% CI, -3.3 to 0.8]; P=0.221). There were no significant differences in the change in LDL-C level, physical activity, body mass index, or smoking status between the 2 groups. Nearly all patients in the intervention group reported the text messages to be useful (96.1%), easy to understand (98.8%), appropriate in frequency (93.8%), and reported being willing to receive future text messages (94.8%). CONCLUSIONS Text messages supporting secondary prevention among patients with coronary heart disease did not lead to a greater reduction in blood pressure at 6 months. Mobile phone text messaging for secondary prevention was feasible and highly acceptable to patients. CLINICAL TRIAL REGISTRATION URL: https://clinicaltrials.gov . Unique identifier: NCT02888769.
Four-year pain relief after coblation combined with active exercise for cervical discogenic pain: Case report.
RATIONALE Coblation of intervertebral disc is an effective and safe minimally invasive technology for treating discogenic pain. The inactivation of neural ingrowth around annulus and tissue ablation and coagulation are currently considered to be the major causes for success of this treatment. However, it has been found by clinical researchers that its long-term clinical outcome is not optimistic. This report has given us favorable information that this situation can be improved with multimodal therapy. PATIENT CONCERNS A 61-year-old man presented with right severe neck and shoulder pain in 2014 which could not be relieved by medications. DIAGNOSES According to his symptoms and signs, this patient was diagnosed with cervical discogenic pain. And discography confirmed the diagnosis. INTERVENTIONS The patient underwent coblation of cervical intervertebral disc 4-5 (C4-5) and got apparently pain relief after surgery. After 1 month, he began to perform active exercise at least 30 min every day. OUTCOMES The right neck and shoulder pain completely relieved for 4 years. The cervical lordosis of this patient was restored in 2018 which was confirmed by MRI compared in 2014 and NDI (neck disability index) decreased from 58 to 10%. LESSONS This report demonstrated that it was important and essential for clinicians to educate patients with discogenic pain to perform active exercise after minimally invasive surgery.
Impaired heart rate recovery as a predictor for poor health-related quality in patients with transient ischemic attack.
We aimed to investigate heart rate recovery (HRR) in patients with transient ischemic attack (TIA) and the relationship between HRR and health-related quality of life (HRQOL).All available patients were enrolled during the enrollment period. A total of 120 patients with TIA and 120 healthy controls were included in this study. A treadmill stress test was performed to calculate the HRR. The HRR were calculated as follows: HRR 1, 2, 3, and 5 minutes = heart rate at peak during exercise - heart rate at 1, 2, 3, and 5 minutes at rest. All patients enrolled were asked to fill in the Short Form 36 Health Survey to calculate HRQOL.We found that the maximum heart rate of TIA patients was significantly higher than that of healthy controls (166 ± 11 vs. 162 ± 14 beats/min, P = .015). Similarly, maximum systolic blood pressure (SBP) and diastolic blood pressure (DBP) were higher in TIA group compared with healthy control group (SBP: 172 ± 15 vs. 165 ± 14 mm Hg, P < .001; DBP: 102 ± 12 vs. 93 ± 16 mm Hg, P < .001). The HRR were significantly lower in TIA group compared with control group (TIA vs. controls, HRR1: 17 ± 7 vs. 30 ± 8 beats/min, HRR2: 32 ± 11 vs. 49 ± 9 beats/min, HRR3: 43 ± 13 vs. 63 ± 12 beats/min, HRR5: 54 ± 16 vs. 73 ± 15 beats/min, all P < .001). Multivariate analysis showed that older age (P = .03) and high BMI (P = .04) were risk factors associated with abnormal HRR in patients with TIA. With regard to HRQOL, we found that role limitations due to physical problems, general health, vitality, and role limitations due to emotional problems were significantly lower in patients with abnormal HRR compared with patients with normal HRR. Multivariate analysis showed that older age (P = .04) and abnormal HRR (P = .03) were predictors for poor HRQOL in TIA patients.HRR was impaired in patients with TIA. In addition, TIA patients with abnormal HRR suffered from a significantly poorer HRQOL. Hence, given the prognostic value of HRR, patients with TIA should be monitored to prevent cardiovascular events and to improve HRQOL.
Gut microbiota metabolites, amino acid metabolites and improvements in insulin sensitivity and glucose metabolism: the POUNDS Lost trial.
OBJECTIVE Alterations in gut microbiota have been linked to host insulin resistance, diabetes and impaired amino acid metabolism. We investigated whether changes in gut microbiota-dependent metabolite of trimethylamine N-oxide (TMAO) and its nutrient precursors (choline and L-carnitine) were associated with improvements in glucose metabolism and diabetes-related amino acids in a weight-loss diet intervention. DESIGN We included 504 overweight and obese adults who were randomly assigned to one of four energy-reduced diets varying in macronutrient intake. The 6-month changes (Δ) in TMAO, choline and L-carnitine levels after the intervention were calculated. RESULTS Greater decreases in choline and L-carnitine were significantly (p<0.05) associated with greater improvements in fasting insulin concentrations and homeostasis model assessment of insulin resistance (HOMA-IR) at 6 months. The reduction of choline was significantly related to 2-year improvements in glucose and insulin resistance. We found significant linkages between dietary fat intake and ΔTMAO for changes in fasting glucose, insulin and HOMA-IR (pinteraction <0.05); a greater increase in TMAO was related to lesser improvements in the outcomes among participants who consumed a high-fat diet. In addition, ΔL-carnitine and Δcholine were significantly related to changes in amino acids (including branched-chain and aromatic amino acids). Interestingly, the associations of ΔTMAO, Δcholine and ΔL-carnitine with diabetes-related traits were independent of the changes in amino acids. CONCLUSION Our findings underscore the importance of changes in TMAO, choline and L-carnitine in improving insulin sensitivity during a weight-loss intervention for obese patients. Dietary fat intake may modify the associations of TMAO with insulin sensitivity and glucose metabolism. TRIAL REGISTRATION NUMBER NCT00072995.
Effect of Core Stability Training Monitored by Rehabilitative Ultrasound Image and Surface Electromyogram in Local Core Muscles of Healthy People.
Pain research & management. 2019;:9130959
Background: The purpose of this study is to investigate the influence of transverses abdominis and lumbar multifidus thickness activation and electromyogram signal characteristics after core stability training monitored by rehabilitative ultrasound imaging and surface electromyogram. Methods: 60 healthy volunteers were allocated randomly into two groups, one of which received monitoring training and the other participated identical training without monitoring. Ultrasound image and surface electromyogram signal were collected at 0, 4, and 8 weeks during training. The muscle thickness activation ratio value and integrated electromyogram value were then extracted. During the training, the monitoring group was monitored by real-time rehabilitative ultrasound imaging and surface electromyogram while the control group was not. Results: There are no differences in performance of local core muscles between both groups before training (p > 0.05). Compared with the control group, the thickness contraction ratio value and integrated electromyogram value of core muscles in the monitoring group were higher after 8 weeks' training (p < 0.05). Conclusion: Together, the core stability training monitored by rehabilitative ultrasound imaging and surface electromyogram can markedly activate and enhance local core muscles in healthy people, providing a potential strategy to treat low back pain more effectively.