scholarly journals Effect of dental intervention on improvements in metabolic syndrome patients: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Midori Doke ◽  
Yuriko Komagamine ◽  
Manabu Kanazawa ◽  
Maiko Iwaki ◽  
Hiroyuki Suzuki ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
University Hospital ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Dental Intervention ◽  
Water Rate

Abstract Background Metabolic syndrome (MetS), caused by the accumulation of visceral fat, is considered a major cause of cardiovascular disease. This randomized controlled trial aimed to clarify the effect of dental intervention, including prosthodontics and/or periodontal treatment, combined with dietary and exercise guidance on MetS. Methods In total, 112 patients who met the Japanese waist circumference criteria of MetS were recruited. The intervention group (ITG) received dental intervention along with dietary and exercise guidance, while the control group (CTG) received dietary and exercise guidance alone. Three outcome measurements were obtained before intervention (BL), 1 month after intervention (1M), and 3 months after intervention (3M). Results Body water rate (p = 0.043) was significantly higher in ITG than in CTG at 1M. Simultaneously, fasting blood sugar level (p = 0.098) tended to be lower in ITG than in CTG. Lean mass (p = 0.037) and muscle mass (p = 0.035) were significantly higher and body weight (p = 0.044) significantly lower in ITG than in CTG at 3M. Body mass index (p = 0.052) tended to be lower in ITG than in CTG. Conclusions Dental intervention combined with lifestyle guidance may improve anthropometric status and reduce the risk of MetS. Trial registration University Hospital Medical Information Network Center Unique UMIN000022753. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026176.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

scholarly journals App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Stephanie Erika Bonn ◽  
Mari Hult ◽  
Kristina Spetz ◽  
Marie Löf ◽  
Ellen Andersson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Bariatric Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Participant ◽  
Lifestyle Factors ◽  
Lifestyle Changes ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

Changing the Obesogenic Environment to Improve Cardiometabolic Health in Residential Patients with a Severe Mental Illness: ELIPS, a Randomized Controlled Trial

2017 ◽  
Vol 41 (S1) ◽  
pp. S267-S268 ◽  
Author(s):  
F. Jörg ◽  
A. Looijmans ◽  
A. Stiekema ◽  
L. Van der Meer ◽  
R. Schoevers ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Controlled Trial ◽  
Clinical Care ◽  
Pragmatic Trial ◽  
Intervention Group ◽  
Cardiometabolic Health ◽  
Control Group ◽  
Obesogenic Environment ◽  
Randomized Controlled ◽  
Small Change

IntroductionThe life expectancy of severe mentally ill (SMI) patients is shortened up to 30 years, due to cardiometabolic diseases, partly caused by unhealthy lifestyles behaviors. In residential facilities, adopting a healthy lifestyle is hampered by the obesogenic environment; an obesity promoting environment.ObjectiveTo determine, the effectiveness of a 12 month lifestyle intervention addressing the obesogenic environment to improve cardiometabolic health of SMI residential patients.MethodsThe effectiveness of lifestyle interventions in psychiatry (ELIPS) trial is a multi-site, cluster randomized controlled pragmatic trial. Twenty-nine sheltered and long-term clinical care teams serving SMI patients in the Netherlands were randomized into intervention (n = 15) or control (n = 14) arm, including 736 patients (73% psychotic disorder, 63% male, 48 ± 13 years). The intervention aimed to improve the obesogenic environment using a small change approach with a focus on nutrition and physical activity. Primary outcome was waist circumference (WC) after three and twelve month's intervention. Secondary outcomes were BMI and metabolic syndrome.ResultsGeneral linear mixed models adjusted for age, gender, housing facility and antipsychotic medication showed that WC significantly decreased with 1.51 cm (95%CI = −2.99;−0.04, Cohen's d = 0.07) in the intervention group compared to control group after three months and tended to remain lower with 1.28 cm (95%CI = −2.79; 0.23, Cohen's d = 0.06) after twelve months. Metabolic syndrome Z-score decreased after three months with 0.225 SD (95% CI = −0.4038;−0.096, Cohen's d = 0.20), mainly due to lower fasting glucose and WC. No significant effects were found on BMI.ConclusionA small change approach targeting the obesogenic environment of SMI residential patients reduces cardiometabolic risk.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

scholarly journals The Effects of the Dietary Approaches to Stop Hypertension (DASH) Diet on Metabolic Syndrome in Hospitalized Schizophrenic Patients: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2950 ◽  
Author(s):  
Tamara Sorić ◽  
Mladen Mavar ◽  
Ivana Rumbak
Keyword(s):  
Metabolic Syndrome ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Dash Diet ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Schizophrenic Patients ◽  
The Relationship

The relationship between the Dietary Approaches to Stop Hypertension (DASH) diet and metabolic syndrome (MetS) in people with schizophrenia is unknown and remains to be investigated. Therefore, we have conducted a three-month parallel-group randomized controlled trial. Sixty-seven hospitalized schizophrenic patients with MetS [n = 33 in the intervention group (IG) and n = 34 in the control group (CG)] completed the intervention. The IG followed the DASH diet with the caloric restriction of approximately 1673.6 kJ/day (400 kcal/day) when compared to the standard hospital diet followed by the CG. Simultaneously, both groups participated in a nutrition counseling program. Anthropometric and biochemical parameters and blood pressure were measured at the baseline and after three months, while nutrient intakes during the intervention were assessed using three non-consecutive 24-hour dietary recalls. The analyses were carried out based on the per-protocol approach. At three months, the MetS prevalence significantly decreased in both the IG and the CG (75.8%, p = 0.002, and 67.7%, p = 0.0003, respectively; odds ratio = 0.9; 95% confidence interval = 0.43–1.87). No significant differences in the prevalence of MetS and its features were found between the groups.

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

BACKGROUND Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. OBJECTIVE The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. METHODS This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. RESULTS The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (<i>P</i>&lt;.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (<i>P</i>&lt;.001). CONCLUSIONS Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. CLINICALTRIAL Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

scholarly journals Role of Esomeprazole in Early Preeclampsia: A Randomized Controlled Trial

2021 ◽  
Vol 8 (6) ◽  
Author(s):  
Atwa KA ◽  
◽  
Ibrahim ZM ◽  
Elshaer M ◽  
Taha OT ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Gestational Age ◽  
Controlled Trial ◽  
Intervention Group ◽  
University Hospital ◽  
Control Group ◽  
Singleton Pregnancy ◽  
Expectant Treatment ◽  
Randomized Controlled ◽  
Significant Prolongation

Objective: To investigate the efficacy of esomeprazole in managing early preeclampsia. Methods: This randomized controlled trial was conducted at the Obstetric/Gynecology department of Suez Canal University Hospital. We included 160 women between 26-31 years of age, with a singleton pregnancy. Eighty women received esomeprazole along with expectant treatment, whereas 80 women received expectant treatment alone. They were followed up from the date of diagnosis up to four weeks after delivery. The gestational age at termination as well as any complications during the follow-up period were documented and compared between both groups. Results: The mean age of the participants was 30.64 ± 1.62. The gestation of women in the intervention group was longer than those within the control group, with a gestational age at termination of 34.53 ± 1.21 versus 32.78 ± 1.60, respectively (P<0.001). Moreover, women in the intervention group had significantly lower incidences of fits (P= 0.005), antepartum hemorrhage (P=0.005), DIC (P=0.032), and IUFD (P<0.001). Conclusions: Esomeprazole is associated with a significant prolongation of gestation in women with early preeclampsia.

Does Additional Extracorporeal Shock Wave Therapy Improve the Effect of Isolated Percutaneous Radiofreqency Coblation in Patients with Insertional Achilles Tendinopathy? Study Protocol for A Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Yu-Jie Song ◽  
Wen-Kai Xuan ◽  
Ying-Hui Hua
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Achilles Tendinopathy ◽  
Conclusive Evidence ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Extracorporeal Shock Wave ◽  
Insertional Achilles Tendinopathy

Abstract Background: No conclusive evidence recommends a prior treatment for insertional Achilles tendinopathy (IAT). It is theorized that both percutaneous radiofreqency coblation and extracorporeal shockwave therapy (ESWT) relieve pain within the insertion. However, no clinical evidence shows that either treatment promote the regeneration of the tendon or if the combination of these 2 interventions offer better function and less pain than one therapy. Methods: The study is a randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients with insertional Achilles tendinopathy who are not satisfied with the effect of conservative treatment will be screened. A minimum of 38 patients will be enrolled after deciding to participate in the trial on an informed basis. Then the intervention group and the control group perform radial ESWT and sham-ESWT respectively at 6 months after percutaneous radiofreqency coblation. The primary outcome will be the Victorian Institute of Sports Assessment Achilles (VISA-A) Score. Secondary outcome measures will be Foot and Ankle Outcome Score (FAOS) scale, Visual Analogue Scale (VAS), Tegner Score, and MRI ultra-short echo time (UTE) T2* value. The assessments will occur in 6 months, 1 year, and 2 years post-operatively. The differences between 2 groups will be conducted as intention-to-treat basis. Discussion: We aim to investigate if radiofreqency coblation associated with ESWT can provide more encouraging imaging findings as well as functional and clinical outcomes regarding the treatment of the IAT comparing to the single radiofreqency coblation treatment.Trial registration: ChiCTR1800017898; Pre-results. Registered on 20 August 2018.

scholarly journals Effectiveness of the I2AO2 interdisciplinary programme led by nurses on metabolic syndrome and cardiovascular risk: a randomized, controlled trial

2018 ◽  
Vol 46 (6) ◽  
pp. 2202-2218
Author(s):  
V. E. Fernández-Ruiz ◽  
J. A. Paniagua-Urbano ◽  
M. Solé-Agustí ◽  
A. Ruiz-Sánchez ◽  
J. Gómez-Marín ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Cardiovascular Risk ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Long Term Effects ◽  
Anthropometric Parameters ◽  
Post Intervention ◽  
Randomized Controlled

Objective To evaluate the effectiveness of an interdisciplinary programme led by nurses in relation to metabolic syndrome (MS) and cardiovascular risk (CVR). Methods This randomized, controlled, clinical trial included 74 patients diagnosed with MS (experimental group [EG], n = 37; control group [CG], n = 37). The intervention consisted of a 12-month interdisciplinary programme (pre-test, 6 months of intervention, 12 months of intervention, and 1-year follow-up post-intervention) coordinated by nursing. Results We found a progressive and significant reduction for all clinical, biochemical, and anthropometric parameters analysed at different time points. In the EG, remission of MS by 48.1% in the short term was observed (83.8% in the medium term) and maintained at 1 year post-intervention. In the CG, the prevalence of MS increased by 2.7% from the initial evaluation to study completion. A similar trend was observed for CVR. In the EG, 100% of subjects had a moderate-low risk of CVR at 1 year post-intervention, whereas the CG had CVR in all categories. Conclusion An interdisciplinary, nurse-led programme improves participants’ metabolic and cardiovascular health, while maintaining long-term effects. Our findings suggest an important role of the professional nurse as a nexus between the patient, different professionals, and the community.

Effectiveness of an overall progressive resistance strength program for improving the functional capacity of patients with rheumatoid arthritis: a randomized controlled trial

2017 ◽  
Vol 31 (11) ◽  
pp. 1482-1491 ◽  
Author(s):  
Felipe Martinelli Lourenzi ◽  
Anamaria Jones ◽  
Daniele Freitas Pereira ◽  
João Henrique Costa Alves dos Santos ◽  
Rita Nely Vilar Furtado ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Strength Training ◽  
Functional Capacity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Progressive Resistance

Objective: To evaluate the effectiveness of overall progressive resistance training in patients with rheumatoid arthritis. Design: Randomized controlled clinical trial with blinded assessor and intention-to-treat analysis. Setting: Outpatient clinics. Subjects: Sixty patients with rheumatoid arthritis according to the American College of Rheumatology criteria, aged between 18 and 65 years old, under stable medication and not performing regular physical activity were randomized into two groups: intervention group (IG) and control group (CG). Interventions: IG performed the progressive resistance strength training, twice a week, during 12 weeks. The training consists of exercising various muscle groups using a load of 50% and 70% of one repetition maximum. The load was reassessed and adjusted after six weeks of baseline. Both groups remained in conventional drug treatment during the study. Main measures: Patients were evaluated at baseline and after 6, 12, and 24 weeks, using HAQ and SF-36 questionnaires and strength. Results: Thirty-three patients in the CG and 27 in the IG were evaluated. The groups were homogeneous at baseline. Statistical and clinical improvement were found with better results for the IG in the HAQ questionnaire ( P=0.030), functional capacity (0=0.022) and pain ( P=0.027) domains of SF-36; and muscle strength for flexors of right and left knee ( P=0.005 and p=0.14), abductors of shoulder ( P=0.041) and extensors of right and left wrists ( P=0.003 and P= 0.005). Conclusions: This progressive resistance strength training improves physical function as well as grip and muscular strength of knee flexors, shoulder abductors and wrist extensors in patients with RA, without adverse effects.

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