scholarly journals PROFAST: A Randomized Trial Assessing the Effects of Intermittent Fasting and Lacticaseibacillus rhamnosus Probiotic among People with Prediabetes

Nutrients ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3530
Author(s):  
Audrey Tay ◽  
Hannah Pringle ◽  
Elise Penning ◽  
Lindsay D. Plank ◽  
Rinki Murphy
Keyword(s):  
Weight Loss ◽  
Primary Outcome ◽  
Synergistic Effects ◽  
Gut Hormones ◽  
Group Differences ◽  
Intermittent Fasting ◽  
Psychological Benefits ◽  
Secondary Outcomes ◽  
Double Blinded

Both intermittent fasting and specific probiotics have shown promise in improving glucose tolerance with a potential for synergistic effects through alterations to gut microbiota. In this randomized, double-blinded, two-arm feasibility study, we investigated whether intermittent fasting, supplemented with Lacticaseibacillus rhamnosus HN001 probiotic, reduces HbA1c in individuals with prediabetes. All participants with HbA1c 40–50 mmol/mol commenced intermittent fasting (2 days per week of calorie restriction to 600–650 kcal/day) and were randomized 1:1 to either daily probiotic (Lacticaseibacillus rhamnosus HN001) or placebo for 12 weeks. The primary outcome was a change in HbA1c. Secondary outcomes included changes in anthropometry, body composition, glucoregulatory markers, lipids, hunger hormones, liver enzymes, inflammatory markers, gut hormones, calorie and macronutrient intake, quality of life, hunger, mood and eating behavior. Of 33 participants who commenced the trial, 26 participants (mean age 52 years, body mass index (BMI) 34.7 kg/m2) completed the intervention (n = 11 placebo, n = 15 probiotic). HbA1c decreased from 43 ± 2.7 mmol/mol to 41 ± 2.3 mmol/mol, p < 0.001, with average of 5% weight loss. No significant between-group differences were seen in primary or secondary outcomes except for social functioning (p = 0.050) and mental health (p = 0.007) scores as improvements were seen in the probiotic group, but not in the placebo group. This study shows additional psychological benefits of probiotic supplementation during intermittent fasting to achieve weight loss and glycemic improvement in prediabetes.

scholarly journals Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)

2021 ◽  
pp. annrheumdis-2020-219091 ◽  
Author(s):  
Gary J Macfarlane ◽  
Marcus Beasley ◽  
Neil Scott ◽  
Huey Chong ◽  
Paul McNamee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Primary Outcome ◽  
Population Based ◽  
Behavioural Therapy ◽  
Short Course ◽  
Life Years ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveCognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.MethodsA population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.Results996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.ConclusionsA short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.Trial registration numberClinicalTrials.gov Registry (NCT02668003).

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

scholarly journals A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lara Bücker ◽  
Josefine Gehlenborg ◽  
Steffen Moritz ◽  
Stefan Westermann
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Control Group ◽  
Gambling Problems ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

scholarly journals Frailty and the Kidney Transplant Wait List: Protocol for a Multicenter Prospective Study

2020 ◽  
Vol 7 ◽  
pp. 205435812095743
Author(s):  
Karthik K. Tennankore ◽  
Lakshman Gunaratnam ◽  
Rita S. Suri ◽  
Seychelle Yohanna ◽  
Michael Walsh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Kidney Transplant ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Frailty Index ◽  
Wait List ◽  
Relative Hazard ◽  
Risk Of Death ◽  
Secondary Outcomes

Background: Understanding how frailty affects patients listed for transplantation has been identified as a priority research need. Frailty may be associated with a high risk of death or wait-list withdrawal, but this has not been evaluated in a large multicenter cohort of Canadian wait-listed patients. Objective: The primary objective is to evaluate whether frailty is associated with death or permanent withdrawal from the transplant wait list. Secondary objectives include assessing whether frailty is associated with hospitalization, quality of life, and the probability of being accepted to the wait list. Design: Prospective cohort study. Setting: Seven sites with established renal transplant programs that evaluate patients for the kidney transplant wait list. Patients: Individuals who are being considered for the kidney transplant wait list. Measurements: We will assess frailty using the Fried Phenotype, a frailty index, the Short Physical Performance Battery, and the Clinical Frailty Scale at the time of listing for transplantation. We will also assess frailty at the time of referral to the wait list and annually after listing in a subgroup of patients. Methods: The primary outcome of the composite of time to death or permanent wait-list withdrawal will be compared between patients who are frail and those who are not frail and will account for the competing risks of deceased and live donor transplantation. Secondary outcomes will include number of hospitalizations and length of stay, and in a subset, changes in frailty severity over time, change in quality of life, and the probability of being listed. Recruitment of 1165 patients will provide >80% power to identify a relative hazard of ≥1.7 comparing patients who are frail to those who are not frail for the primary outcome (2-sided α = .05), whereas a more conservative recruitment target of 624 patients will provide >80% power to identify a relative hazard of ≥2.0. Results: Through December 2019, 665 assessments of frailty (inclusive of those for the primary outcome and all secondary outcomes including repeated measures) have been completed. Limitations: There may be variation across sites in the processes of referral and listing for transplantation that will require consideration in the analysis and results. Conclusions: This study will provide a detailed understanding of the association between frailty and outcomes for wait-listed patients. Understanding this association is necessary before routinely measuring frailty as part of the wait-list eligibility assessment and prior to ascertaining the need for interventions that may modify frailty. Trial Registration: Not applicable as this is a protocol for a prospective observational study.

scholarly journals Restarting antiplatelet therapy after spontaneous intracerebral hemorrhage

Neurology ◽  
2018 ◽  
Vol 91 (1) ◽  
pp. e26-e36 ◽  
Author(s):  
Ching-Jen Chen ◽  
Dale Ding ◽  
Thomas J. Buell ◽  
Fernando D. Testai ◽  
Sebastian Koch ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intracerebral Hemorrhage ◽  
Functional Outcomes ◽  
Primary Outcome ◽  
Modified Rankin Scale ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Secondary Outcomes

ObjectiveTo compare the functional outcomes and health-related quality of life metrics of restarting vs not restarting antiplatelet therapy (APT) in patients presenting with intracerebral hemorrhage (ICH) in the ERICH (Ethnic/Racial Variations of Intracerebral Hemorrhage) study.MethodsAdult patients aged 18 years and older who were on APT before ICH and were alive at hospital discharge were included. Patients were dichotomized based on whether or not APT was restarted after hospital discharge. The primary outcome was a modified Rankin Scale score of 0–2 at 90 days. Secondary outcomes were excellent outcome (modified Rankin Scale score 0–1), mortality, Barthel Index, and health status (EuroQol–5 dimensions [EQ-5D] and EQ-5D visual analog scale scores) at 90 days.ResultsThe APT and no APT cohorts comprised 127 and 732 patients, respectively. Restarting APT was associated with lower rates of good functional outcome (36.5% vs 40.8%; p = 0.021) and lower Barthel Index scores at 90 days (p = 0.041). The 2 cohorts were then matched in a 1:1 ratio, and the matched cohorts each comprised 107 patients. No difference in primary outcome was observed between restarting vs not restarting APT (35.5% vs 43.9%; p = 0.105). There were also no differences between the secondary outcomes of the 2 cohorts.ConclusionRestarting APT in patients with ICH of mild to moderate severity after acute hospitalization is not associated with worse functional outcomes or health-related quality of life at 90 days. In patients with significant cardiovascular risk factors who experience an ICH, restarting APT remains the decision of the treating practitioner.

scholarly journals Effect of acupuncture on lung cancer-related fatigue: study protocol for a multi-center randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Zhaoqin Wang ◽  
Shanshan Li ◽  
Luyi Wu ◽  
Qin Qi ◽  
Huirong Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Primary Outcome ◽  
Acupuncture Treatment ◽  
Acupuncture Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cancer Related Fatigue ◽  
Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0% in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited. Method/design This is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT. Discussion This trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment. Trial registration Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: http://www.chictr.org.cn/showproj.aspx?proj=37823

scholarly journals Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

2016 ◽  
Vol 41 (9) ◽  
pp. 948-956 ◽  
Author(s):  
C. Jerosch-Herold ◽  
J. Houghton ◽  
L. Miller ◽  
L. Shepstone
Keyword(s):  
Carpal Tunnel ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Hand Function ◽  
Group Differences ◽  
Level Of Evidence ◽  
Significant Treatment ◽  
Significant Group ◽  
Group A ◽  
Secondary Outcomes

Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning ( n = 52) or control ( n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II

scholarly journals Self-concept in poor readers: a systematic review and meta-analysis

PeerJ ◽  
2020 ◽  
Vol 8 ◽  
pp. e8772 ◽  
Author(s):  
Genevieve M. McArthur ◽  
Nicola Filardi ◽  
Deanna A. Francis ◽  
Mark E. Boyes ◽  
Nicholas A. Badcock
Keyword(s):  
Systematic Review ◽  
Primary Outcome ◽  
Strong Association ◽  
Physical Appearance ◽  
Self Concept ◽  
Poor Reading ◽  
Quality Of Evidence ◽  
Secondary Outcomes ◽  
Meta Analyses

Background The aims of this systematic review and meta-analyses were to determine if there is a statistically reliable association between poor reading and poor self-concept, and if such an association is moderated by domain of self-concept, type of reading impairment, or contextual factors including age, gender, reading instruction, and school environment. Methodology We searched 10 key databases for published and unpublished studies, as well as reference lists of included studies, and studies that cited included studies. We calculated standardised mean differences (SMDs) and 95% confidence intervals for one primary outcome (average self-concept) and 10 secondary outcomes (10 domains of self-concept). We assessed the data for risk of bias, heterogeneity, sensitivity, reporting bias, and quality of evidence. Results Thirteen studies with 3,348 participants met our selection criteria. Meta-analyses revealed statistically significant SMDs for average self-concept (−0.57) and five domains of self-concept (reading/writing/spelling: −1.03; academic: −0.67; math: −0.64; behaviour: −0.32; physical appearance: −0.28). The quality of evidence for the primary outcome was moderate, and for secondary outcomes was low, due to lack of data. Conclusions These outcomes suggest a probable moderate association between poor reading and average self-concept; a possible strong association between poor reading and reading-writing-spelling self-concept; and possible moderate associations between poor reading and self-concept in the self-concept domains of academia, mathematics, behaviour, and physical appearance.

scholarly journals Efficacy of montelukast in the management of COVID-19: double blind randomized placebo controlled trial

2021 ◽  
Vol 10 (12) ◽  
pp. 1374
Author(s):  
Vijay Kumar ◽  
Avinash A. Ganapule ◽  
Sushmita Supriya ◽  
Divendu Bhushan ◽  
Pallavi Lohani ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Final Analysis ◽  
Standard Operating Procedure ◽  
Double Blind ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Double Blinded

Background: Objective of the study was to determine the efficacy of montelukast in reducing the severity of COVID-19 symptoms using a double blinded randomized controlled trial.Methods: Parallel, double-blinded randomized controlled trial (RCT) with placebo as comparison to montelukast. All patients above the age of 14 years both males and females, admitted with a diagnosis of mild or moderate COVID-19 (on the basis of a positive reverse transcriptase polymerase chain reaction (RT-PCR) report) at our facility during the study period from 01 September 2020-31 January 2021) and excluding those having adverse reaction to montelukast or those not willing to participate, and pregnant and lactating females. Patients in the intervention arm were given tablet montelukast 10 mg OD HS from the day of admission for 10 days. The patients in the placebo group were given an identical appearing placebo at bedtime for 10 days from the day of admission. The rest of the treatment was given as per the standard operating procedure (SOP) of the institute with minor adjustments as per the treating team’s judgement. Primary outcome was progression of the disease to severe grade and secondary outcomes were discharge on or before day 10 from admission, admission to ICU, need for mechanical ventilation and in-hospital mortality.Results: A total of 94 patients were enrolled for the study. 90 patients, 45 in each arm were included in the final analysis. The baseline characteristics of the two arms including age, sex, comorbidities, severity at admission and treatment given apart from montelukast or placebo, were comparable with respect to these variables. This study did not find any improvement in primary outcome of progression to severe disease and secondary outcomes of intensive care unit (ICU) admission, mortality or need of mechanical ventilation, discharge on or by day 10 with the use of montelukast as compared to placebo in mild to moderate cases of COVID-19.Conclusions: There was no difference in primary or secondary outcomes with the use of Montelukast compared to placebo.

scholarly journals Use of Virtual Reality to Improve the Quality of the Hospital Stay for Patients in Neurosurgery

2021 ◽  
Vol 2 ◽  
Author(s):  
Pia Vayssiere ◽  
Paul E. Constanthin ◽  
Nalla Silva Baticam ◽  
Bruno Herbelin ◽  
Christine Degremont ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Statistical Difference ◽  
Primary Outcome ◽  
Pain Reduction ◽  
Anxiety Management ◽  
Positive Effects ◽  
Duration Of Hospitalization ◽  
Secondary Outcomes ◽  
Simple Spine

Background: Virtual Reality (VR) technologies have numerous beneficial applications for patients during hospitalization (through complete immersion in a virtual, distant place allowing to “escape” from the context of hospitalization). Their positive effects in pain and anxiety management, neurorehabilitation and psychotherapy have been demonstrated. Here, we evaluated the effects of VR on the quality of hospitalization and postoperative pain after neurosurgery.Methods: Patients hospitalized in our department between 2019 and 2020 were prospectively enrolled and divided into a group that received a personal, 30-minutes-long, VR session using an Oculus Go ™ VR headset (VR group) or not (non-VR group). Surgeries were classified in simple or complex spinal and simple or complex cranial. Patient‘s overall satisfaction was considered as primary outcome, with secondary outcomes encompassing duration of hospitalization, pain reduction and patients’ opinion regarding VR.Results: 161 patients were enrolled (77 in the VR group and 84 in the non-VR group). There was no statistical difference between the two groups regarding satisfaction. The VR group presented with a significantly longer duration of hospitalization and higher maximal pain. Interestingly, pain reduction during hospitalization was significantly higher in the VR group, particularly in simple surgeries and spine surgeries. A vast majority of the VR group patients appreciated their VR experience (89.2%) and advocated for its systematic use (83.8%).Conclusion: VR can improve pain reduction during hospitalization after neurosurgery, particularly for simple spine surgeries. Furthermore, patients experiencing VR appear to appreciate it and advocate for its systematic use in neurosurgery. Further research is warranted to identify patients for whom addition of VR during hospitalization might bring the most benefit.

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