-
1.
Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial.
Tantrakul, V, Ingsathit, A, Liamsombut, S, Rattanasiri, S, Kittivoravitkul, P, Imsom-Somboon, N, Lertpongpiroon, S, Jantarasaengaram, S, Somchit, W, Suwansathit, W, et al
Respiratory research. 2023;24(1):171
-
-
-
Free full text
Plain language summary
Preeclampsia is a leading cause of maternal and foetal morbidity and mortality. Obstructive sleep apnoea (OSA) during pregnancy has been identified as a risk factor for preeclampsia and gestational hypertension. Although continuous positive airway pressure (CPAP) is a standard treatment for OSA in the general population, there is limited data regarding the efficacy and safety of CPAP treatment during pregnancy. The aim of this study was to evaluate the efficacy of CPAP treatment in high-risk pregnancy with mild-to-moderate OSA in reducing BP and hypertensive disorders in pregnancy. This study was a multicentre, open-label, parallel-group randomised controlled trial. Pregnant women attending antenatal care at all collaborating hospitals were recruited. Results showed that CPAP significantly reduced blood pressure (BP), with larger effects on diastolic BP and mean arterial pressure than systolic BP. Furthermore, it reduced the incidence of preeclampsia and hypertensive disorders in pregnancy. Authors conclude that their findings raise the need for early diagnosis and treatment of OSA in high-risk pregnancies.
Abstract
BACKGROUND Obstructive sleep apnea (OSA) during pregnancy is a risk factor for preeclampsia possibly through a link to placental physiology. This study evaluates the efficacy of continuous positive airway pressure (CPAP) on the modulation of blood pressure and the reduction in preeclampsia in women with high-risk pregnancy and OSA. METHODS A multicenter open-label, randomized controlled trial comparing CPAP treatment versus usual antenatal care was conducted in three academic hospitals in Bangkok, Thailand. Participants included singleton pregnant women aged older than 18 years with any high-risk condition (i.e., chronic hypertension, obesity, history of preeclampsia or gestational diabetes in the previous pregnancy, or diabetes), and OSA (respiratory disturbance index 5-29.99 events/hour by polysomnography), who presented either in the first trimester (gestational age, GA 0-16 weeks) or subsequently developed OSA during the 2nd trimester (GA 24-28 weeks). The primary endpoint was blood pressure during antenatal care. Secondary endpoints included the incidence of preeclampsia. An intention-to-treat analysis was performed with additional per-protocol and counterfactual analyses for handling of nonadherence. RESULTS Of 340 participants, 96.5% were recruited during the first trimester. Thirty participants were later excluded leaving 153 and 157 participants in the CPAP and usual-care groups for the modified-intention-to-treat analysis. CPAP adherence rate was 32.7% with average use of 2.5 h/night. Overall, CPAP treatment significantly lowered diastolic blood pressure (DBP) by - 2.2 mmHg [95% CI (- 3.9, - 0.4), p = 0.014], representing approximately - 0.5 mmHg per hour of CPAP use [95%CI (- 0.89, - 0.10), p = 0.013]. CPAP treatment also altered the blood pressure trajectory by continuously lowering DBP throughout pregnancy with mean differences (95% CI) of - 3.09 (- 5.34, - 0.93), - 3.49 (- 5.67, - 1.31) and - 3.03 (- 5.20, - 0.85) mmHg at GA 18-20, 24-28, and 32-34 weeks, respectively compared to 0-16 weeks. Preeclampsia rate was 13.1% (20/153 participants) in the CPAP and 22.3% (35/157 participants) in the usual-care group with a risk difference (95% CI) of - 9% (- 18%, - 1%, p-value = 0.032) and a number-needed-to-treat (95% CI) of 11 (1, 21). CONCLUSIONS CPAP treatment in women with even mild-to-moderate OSA and high-risk pregnancy demonstrated reductions in both DBP and the incidence of preeclampsia. CPAP treatment also demonstrated a sustained reduction in DBP throughout gestation. Trial registration ClinicalTrial.GovNCT03356106, retrospectively registered November 29, 2017.
-
2.
Improving health-related quality of life in women with breast, blood, and gynaecological Cancer with an eHealth-enabled 12-week lifestyle intervention: the women's wellness after Cancer program randomised controlled trial.
Seib, C, Anderson, D, McGuire, A, Porter-Steele, J, McDonald, N, Balaam, S, Sapkota, D, McCarthy, AL
BMC cancer. 2022;22(1):747
-
-
-
Free full text
Plain language summary
Aging populations and the increased prevalence of other cancer risk factors have led to an increased incidence of cancer in women globally. Cancer treatments often leave women with a range of residual physical and psychological side effects. Comprehensive cancer rehabilitation can reduce symptom burden and health service utilisation, whilst generally improving health-related quality of life (HRQOL). The primary aim of this study was to test the efficacy of a multimodal, digitised lifestyle intervention on HRQOL of women treated for cancer. This study is a multi-centre, single-blinded, randomised controlled 12-week trial. Fifty-one women previously treated for breast, blood or gynaecological cancer were randomly assigned to either an intervention or usual care arm. Results indicate improvements in many HRQoL domains and in component summary scores. Particularly notable were the improvements in general health and bodily pain, vitality, mental health, and global physical and mental health summary scores among women in the intervention group. Authors conclude that the complex and synergistic effects of many modifiable health behaviours emphasise the need for bundled health behaviour interventions to optimise women’s health and wellbeing after completion of active cancer treatment.
Abstract
BACKGROUND The residual effects of cancer and its treatment can profoundly affect women's quality of life. This paper presents results from a multisite randomized controlled trial that evaluated the clinical benefits of an e-health enabled health promotion intervention (the Women's Wellness after Cancer Program or WWACP) on the health-related quality of life of women recovering from cancer treatment. METHODS Overall, 351 women previously treated for breast, blood or gynaecological cancers were randomly allocated to the intervention (WWACP) or usual care arms. The WWACP comprised a structured 12-week program that included online coaching and an interactive iBook that targeted physical activity, healthy diet, stress and menopause management, sexual wellbeing, smoking cessation, alcohol intake and sleep hygiene. Data were collected via a self-completed electronic survey at baseline (t0), 12 weeks (post-intervention, t1) and 24 weeks (to assess sustained behaviour change, t2). The primary outcome, health-related quality of life (HRQoL), was measured using the Short Form Health Survey (SF-36). RESULTS Following the 12-week lifestyle program, intervention group participants reported statistically significant improvements in general health, bodily pain, vitality, and global physical and mental health scores. Improvements were also noted in the control group across several HRQoL domains, though the magnitude of change was less. CONCLUSIONS The WWACP was associated with improved HRQoL in women previously treated for blood, breast, and gynaecological cancers. Given how the synergy of different lifestyle factors influence health behaviour, interventions accounting for the reciprocity of multiple health behaviours like the WWACP, have real potential for immediate and sustainable change. TRIAL REGISTRATION The protocol for this randomised controlled trial was submitted to the Australian and New Zealand Clinical Trials Registry on 15/07/2014 and approved on 28/07/2014 ( ACTRN12614000800628 ).
-
3.
Sleep and health-related quality of life in women following a cancer diagnosis: results from the Women's Wellness after Cancer Program in Australia.
Edmed, SL, Huda, MM, Smith, SS, Seib, C, Porter-Steele, J, Anderson, D, McCarthy, AL
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2022;30(12):10243-10253
-
-
-
Free full text
-
Plain language summary
Women who have completed treatment for cancer experience physical and psychological sequelae that can negatively affect their quality of life (QoL) and health as they recover from treatment. The aim of this study was to examine the association between sleep problems and health related QoL. This study was a single-blinded, multi-centre randomised controlled trial. In total, 175 participants were randomised to the intervention group and 176 were randomised to the usual care (control) group. Results showed that: - sleep outcomes did not predict mental HRQoL after adjustment for covariates. - sleep duration did not predict physical or mental HRQoL after adjustment. - participants in the intervention group did not show greater long-term adherence to sleep recommendations (i.e. sleeping>7 h). Authors conclude that there was no significant effect of the intervention on the sleep duration outcome or any of the other sleep outcomes measured. Thus, opportunities to optimise and better target sleep interventions should continue to be explored in this population.
Abstract
PURPOSE Sleep disturbance after cancer treatment could compromise recovery. This paper examined the associations between post-treatment sleep problems and health-related quality of life (HRQoL), and the effectiveness of an e-enabled lifestyle intervention on sleep outcomes. METHODS The Women's Wellness after Cancer Program (WWACP) was examined in a single blinded, multi-centre randomised controlled trial. Data were collected from 351 women (Mage = 53.2, SD = 8.8; intervention n = 175, control group n = 176) who had completed surgery, chemotherapy and/or radiotherapy for breast, gynaecological or blood cancers within the previous 24 months. Participants completed the Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention randomisation), and at 12 and 24 weeks later. Sociodemographic information, menopausal symptoms (Greene Climacteric Scale) and HRQoL (36-Item Short Form Health Survey; SF-36) were also collected. Linear panel regression was used to examine the association between sleep variables and SF36 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. A difference-in-difference regression model approach was used to examine the intervention effect on the sleep outcomes. RESULTS After adjustment for potential confounders, the sleep variables (except sleep duration) significantly predicted physical, but not mental, HRQoL. There was no statistically significant effect of the intervention on sleep outcomes at 12 or 24 weeks. CONCLUSION Women who have completed treatment for cancer experience sleep problems that are associated with decreased physical HRQoL. Improving sleep through targeted interventions should improve their physical HRQoL. Improved targeting of the sleep components of the WWACP should be explored.
-
4.
Usefulness of a Lifestyle Intervention in Patients With Cardiovascular Disease.
Broers, ER, Gavidia, G, Wetzels, M, Ribas, V, Ayoola, I, Piera-Jimenez, J, Widdershoven, JWMG, Habibović, M
The American journal of cardiology. 2020;125(3):370-375
-
-
-
Free full text
Plain language summary
Modifiable (behavioural) risk factors such as sedentary lifestyle and low sleep efficiency, are associated with increased mortality risk and disease progression in individuals with cardiovascular disease. The main aim of this study was to evaluate changes in objectively measured lifestyle and health data derived from wearable devices. This study was part of an international, multicenter randomized controlled trial, the Do Cardiac Health Advanced New Generation Ecosystem 2 study. Only the participants (n=70) randomised to the intervention group were analysed. The participants received the devices to monitor their lifestyle and health parameters. Results indicate significant changes over time in the number of steps and activity level. No significant improvement over time was observed in other outcome measures (i.e., blood pressure, weight, and sleep efficiency). Secondary analysis showed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. Authors conclude that a personalised approach might be the way forward in order to improve health outcomes in the future.
Abstract
The importance of modifying lifestyle factors in order to improve prognosis in cardiac patients is well-known. Current study aims to evaluate the effects of a lifestyle intervention on changes in lifestyle- and health data derived from wearable devices. Cardiac patients from Spain (n = 34) and The Netherlands (n = 36) were included in the current analysis. Data were collected for 210 days, using the Fitbit activity tracker, Beddit sleep tracker, Moves app (GPS tracker), and the Careportal home monitoring system. Locally Weighted Error Sum of Squares regression assessed trajectories of outcome variables. Linear Mixed Effects regression analysis was used to find relevant predictors of improvement deterioration of outcome measures. Analysis showed that Number of Steps and Activity Level significantly changed over time (F = 58.21, p < 0.001; F = 6.33, p = 0.01). No significant changes were observed on blood pressure, weight, and sleep efficiency. Secondary analysis revealed that being male was associated with higher activity levels (F = 12.53, p < 0.001) and higher number of steps (F = 8.44, p < 0.01). Secondary analysis revealed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. In conclusion results showed that physical activity increased over time and that certain subgroups of patients were more likely to have a better lifestyle behaviors based on their demographic, clinical, and psychological profile. This advocates a personalized approach in future studies in order to change lifestyle in cardiac patients.
-
5.
Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial.
Svanevik, M, Risstad, H, Karlsen, TI, Kristinsson, JA, Småstuen, MC, Kolotkin, RL, Søvik, TT, Sandbu, R, Mala, T, Hjelmesæth, J
Obesity surgery. 2018;28(3):606-614
-
-
-
Free full text
-
Plain language summary
Bariatric surgery may induce weight loss, improvement of weight-associated comorbidities, and improved health and well-being. The aim of the study is to compare the effects of standard and distal Rou-en-Y gastric bypass on obesity-specific health related quality of life, weight-related symptoms, eating behaviour, anxiety and depression. The study is a double-blind, parallel-group randomised controlled trial. The participants’ age ranged from 18 to 60 years of age with a BMI of 50 to 60 kg/m2. Results indicated improvements in most patient-reported outcome measures after both surgeries, but no significant difference between groups after surgery in relation to obesity-specific health related quality of life, weight-related symptoms, anxiety and depression, or eating behaviour. Authors conclude that both surgeries lead to sustained weight loss and improved health related quality of life 2 years after surgery in patients with a BMI 50-60kg/m2.
Abstract
BACKGROUND The preferred surgical procedure for treating morbid obesity is debated. Patient-reported outcome measures (PROMs) are relevant for evaluation of the optimal bariatric procedure. METHODS A total of 113 patients with BMI from 50 to 60 were randomly assigned to standard (n = 57) or distal (n = 56) Roux-en-Y gastric bypass (RYGB). Validated PROMS questionnaires were completed at baseline and 2 years after surgery. Data were analyzed using mixed models for repeated measures and the results are expressed as estimated means and mean changes. RESULTS Obesity-related quality of life improved significantly after both procedures, without significant between-group differences (- 0.4 (95% CI = - 8.4, 7.2) points, p = 0.88, ES = 0.06). Both groups had significant reductions in the number of weight-related symptoms and symptom distress score, with a mean group difference (95% CI) of 1.4 (- 0.3, 3.3) symptoms and 5.0 (2.9. 12.8) symptom distress score points. There were no between-group differences for uncontrolled eating (22.0 (17.2-26.7) vs. 28.9 (23.3-34.5) points), cognitive restraint (57.4 (52.0-62.7) vs. 62.1 (57.9-66.2) points), and emotional eating (26.8 (20.5-33.1) vs. 32.6 (25.5-39.7) points). The prevalence of anxiety was 33% after standard and 25% after distal RYGB (p = 0.53), and for depression 12 and 9%, respectively (p = 0.76). CONCLUSIONS There were no statistically significant differences between standard and distal RYGB 2 years post surgery regarding weight loss, obesity-related quality of life, weight-related symptoms, anxiety, depression, or eating behavior. TRIAL REGISTRATION Clinical Trials.gov number NCT00821197.
-
6.
Effect of lifestyle coaching versus care coordination versus treatment as usual in people with severe mental illness and overweight: Two-years follow-up of the randomized CHANGE trial.
Jakobsen, AS, Speyer, H, Nørgaard, HCB, Karlsen, M, Birk, M, Hjorthøj, C, Mors, O, Krogh, J, Gluud, C, Pisinger, C, et al
PloS one. 2017;12(10):e0185881
-
-
-
Free full text
Plain language summary
The authors assessed the long-term effects of lifestyle coaching for individuals with abdominal obesity and schizophrenia spectrum disorders on cardiovascular risk. Subjects were randomized into 3 groups: 12 months of lifestyle coaching and care coordination, care coordination only or treatment as usual (control). Lifestyle coaching consisted of support from a CHANGE coach who had experience in psychiatry and special training in stopping smoking, healthy diets, and monitoring and treatment of lifestyle diseases. There was at least one face to face meeting per week, plus phone calls, text and email messages. Care co-ordination consisted of support by a specially trained psychiatric nurse, with focus on the symptoms of cardiovascular disease, diabetes or obstructive pulmonary disease. Meetings, telephone calls and messages were adjusted based on personal need. The results did not show any significant effects between the groups at 12 months. After 2 years, 25.4% in the CHANGE group, 19.7% in the care coordination group, and 16.9% in the treatment as usual group had lost at least 5% of their baseline weight. There were no statistically significant differences between the groups for cardiorespiratory fitness, BMI, blood lipids and hbA1c, lung function, smoking status, psychotic symptoms or quality of life. It was noted that self-reporting was a limitation to the study, and may have led to errors in reporting, particularly with reference to diet. In addition, only 42.8% of the CHANGE coaching group attended at least 50% of the planned sessions, and the authors note that this made it likely that there would have been no benefit to increasing or decreasing the number of sessions. The authors concluded that coaching did not improve the motivation of participants to change their lifestyle choices in either the short or long term, and therefore may not be the right approach for those with schizophrenia.
Abstract
The objective of this trial was to assess the long-term effect of the CHANGE lifestyle coaching intervention for 428 people with abdominal obesity and schizophrenia spectrum disorders on cardiovascular risk. In this randomized, superiority, multi-center clinical trial, participants were randomized to 12 months of either lifestyle coaching plus care coordination (N = 138), care coordination alone, (N = 142) or treatment as usual (N = 148). There was no effect after 12 months, but we hypothesized that there might have been a delayed treatment effect. Our primary outcome at two-year follow-up was 10-year risk of cardiovascular disease standardized to 60 years of age. After two-years the mean 10-year cardiovascular-disease risk was 8.7% (95% confidence interval (CI) 7.6-9.9%) in the CHANGE group, 7.7% (95% CI 6.5-8.9%) in the care coordination group, and 8.9% (95% CI 6.9-9.2%) in the treatment as usual group (P = 0.24). Also, there were no intervention effects for any secondary or exploratory outcomes, including cardiorespiratory fitness, weight, physical activity, diet and smoking. No reported adverse events could be ascribed to the intervention. We conclude that there was neither any direct nor any long-term effect of individual lifestyle coaching or care coordination on cardiovascular risk factors in people with abdominal obesity and schizophrenia spectrum disorders. The trial was approved by the Ethics Committee of Capitol Region Copenhagen, Denmark (registration number: H-4-2012-051) and the Danish Data Protection Agency (registration number: 01689 RHP-2012-007). The trial was funded by the Mental Health Services of the Capital Region of Denmark, the Lundbeck Foundation, the Tryg Foundation, the Danish Ministry of Health, and the Dæhnfeldts Foundation.
-
7.
Effectiveness and safety of citicoline in mild vascular cognitive impairment: the IDEALE study.
Cotroneo, AM, Castagna, A, Putignano, S, Lacava, R, Fantò, F, Monteleone, F, Rocca, F, Malara, A, Gareri, P
Clinical interventions in aging. 2013;8:131-7
-
-
-
Free full text
Plain language summary
The number of people aged 65 years and over with mild vascular cognitive impairment is continuing to increase. Vascular disease can reduce cerebral perfusion, causing oxidative stress and neurodegeneration. Citicoline [pharmaceutical] inhibits apoptosis associated with cerebral ischemia and in several models of neurodegeneration has been able to potentiate neuroplasticity. The aim of this study was to assess the effectiveness and safety of oral citicoline in elderly people with mild vascular cognitive impairment. A total of 349 patients were included in the study who were assigned to open-label treatment with oral citicoline 500 mg twice a day in a fasting state or to no treatment (controls). Results show that citicoline is effective and safe in the treatment of mild vascular cognitive impairment. The treated group showed improvement in MMSE (Mini-Mental State Examination) scores, with an increase of 0.5 points shown over the course of the study. Authors conclude that further studies are required in order to confirm the findings of this study, and to further assess the efficacy and safety of long-term administration of a dietary supplement such as Cytidine-5′-diphosphate choline.
Abstract
BACKGROUND The studio di intervento nel decadimento vascolare lieve (IDEALE study) was an open multicenter Italian study, the aim of which was to assess the effectiveness and safety of oral citicoline in elderly people with mild vascular cognitive impairment. METHODS The study was performed in 349 patients. The active or citicoline group was composed of 265 patients and included 122 men and 143 women of mean age 79.9 ± 7.8 years selected from six Italian regions. Inclusion criteria were age ≥ 65 years, Mini-Mental State Examination (MMSE) score ≥ 21, subjective memory complaints but no evidence of deficits on MMSE, and evidence of vascular lesions on neuroradiology. Those with probable Alzheimer's disease were excluded. The control group consisted of 84 patients, including 36 men and 48 women of mean age 78.9 ± 7.01 (range 67-90) years. Patients included in the study underwent brain computed tomography or magnetic resonance imaging, and plasma dosage of vitamin B12, folate, and thyroid hormones. Functional dependence was investigated by scores on the Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales, mood was assessed by the Geriatric Depression Scale (GDS), and behavioral disorders using the Neuropsychiatric Inventory scale. Comorbidity was assessed using the Cumulative Illness Rating Scale. An assessment was made at baseline (T0), after 3 months (T1), and after 9 months (T2, ie, 6 months after T1). The main outcomes were an improvement in MMSE, ADL, and IADL scores in the study group compared with the control group. Side effects were also investigated. The study group was administered oral citicoline 500 mg twice a day throughout the study. RESULTS MMSE scores remained unchanged over time (22.4 ± 4 at T0; 22.7 ± 4 at T1; 22.9 ± 4 at T2), whereas a significant difference was found between the study and control groups, both in T1 and in T2. No differences were found in ADL and IADL scores between the two groups. A slight but not statistically significant difference was found in GDS score between the study and control groups (P = 0.06). No adverse events were recorded. CONCLUSION In this study, citicoline was effective and well tolerated in patients with mild vascular cognitive impairment. Citicoline activates biosynthesis of phospholipids in neuronal membranes, increases brain metabolism as well as norepinephrine and dopamine levels in the central nervous system, and has neuroprotective effects during hypoxia and ischemia. Therefore, citicoline may be recommended for patients with mild vascular cognitive impairment.