The Effect of Exercise During Pregnancy on Maternal and Offspring Vascular Outcomes: a Pilot Study

AbstractThe aim of this pilot study is to obtain estimates for the change in maternal cerebrovascular (primary) and offspring vascular structure (secondary) during healthy pregnancy that includes structured exercise. Eighteen pregnant women self-assigned to a moderate-intensity aerobic exercise intervention or a control group. Maternal cerebral blood flow (CBF) at the middle cerebral artery, cerebro- and peripheral-vascular function was assessed at the end of each trimester. Offspring carotid artery intima-media thickness (IMT) was measured within 12 weeks of birth. For exploratory purposes, we performed statistical analysis to provide estimates of the change for primary and secondary outcome variables. Maternal CBF reduced (− 8 cm s−1 [− 14 to − 2]) with evidence of change to cerebral autoregulation (normalised gain: 0.12 %cm s−1% mmHg−1mmHg/% [− 0.18 to 0.40]) during pregnancy. Offspring carotid IMT was smaller in the exercise group (− 0.04 mm [− 0.12–0.03]) compared with controls. Based upon this data, a sample size of 33 and 57 in each group is required for low-frequency normalised gain and offspring IMT, respectively. This would provide 90% power to detect statistically significant (P < 0.05) between group differences in a randomised controlled trial. CBF is reduced in pregnancy, possibly due to reduced vascular resistance and altered maternal cerebral autoregulation. Maternal exercise had negligible effects on cerebrovascular adaptation to pregnancy, but we observed lower offspring carotid artery wall thickness following maternal exercise. Our directional findings and sample size estimations should be explored in a fully powered randomised control trial.Clinical trial registration: The trial was registered on March 14th at https://register.clinicaltrials.gov (NCT03079258). Participant enrolment began on 3rd April 2016.

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Feasibility and Impact of a Combined Supervised Exercise and Nutritional-Behavioral Intervention following Bariatric Surgery: A Pilot Study

Journal of Obesity ◽

10.1155/2015/693829 ◽

2015 ◽

Vol 2015 ◽

pp. 1-12 ◽

Cited By ~ 15

Author(s):

Friedrich C. Jassil ◽

Sean Manning ◽

Neville Lewis ◽

Siri Steinmo ◽

Helen Kingett ◽

...

Keyword(s):

Bariatric Surgery ◽

Pilot Study ◽

Lifestyle Intervention ◽

Behavioral Intervention ◽

Intervention Program ◽

Intervention Group ◽

Activity Level ◽

Randomised Control Trial ◽

Control Group ◽

Supervised Exercise

Background.Lifestyle intervention programs after bariatric surgery have been suggested to maximise health outcomes. This pilot study aimed to investigate the feasibility and impact of an 8-week combined supervised exercise with nutritional-behavioral intervention following Roux-en-Y gastric bypass and sleeve gastrectomy.Methods.Eight female patients (44 ± 8 years old, BMI = 38.5 ± 7.2 kgm−2) completed the program. Before and after intervention, anthropometric measures, six-minute walk test (6MWT), physical activity level, eating behavior, and quality of life (QoL) were assessed. Percentage weight loss (%WL) outcomes were compared with a historical matched control group.Results.The program significantly improved functional capacity (mean increment in 6MWT was 127 ± 107 meters,p=0.043), increased strenuous intensity exercise (44 ± 49 min/week,p=0.043), increased consumption of fruits and vegetables (p=0.034), reduced consumption of ready meals (p=0.034), and improved “Change in Health” in QoL domain (p=0.039). The intervention group exhibited greater %WL in the 3–12-month postsurgery period compared to historical controls, 12.2 ± 7.5% versus 5.1 ± 5.4%, respectively (p=0.027).Conclusions.Lifestyle intervention program following bariatric surgery is feasible and resulted in several beneficial outcomes. A large randomised control trial is now warranted.

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A Stopped Pilot Study of the ProGlide Closure Device After Transbrachial Endovascular Interventions

Journal of Endovascular Therapy ◽

10.1177/1526602819862775 ◽

2019 ◽

Vol 26 (5) ◽

pp. 727-731 ◽

Cited By ~ 2

Author(s):

Max M. Meertens ◽

Michiel W. de Haan ◽

Geert W. H. Schurink ◽

Barend M. E. Mees

Keyword(s):

Pilot Study ◽

Brachial Artery ◽

Secondary Outcome ◽

Control Group ◽

Closure Device ◽

Manual Compression ◽

Access Site ◽

Historical Cohort ◽

Endovascular Interventions ◽

High Incidence

Purpose: To evaluate the feasibility and safety of the suture-mediated ProGlide device in closure of the brachial artery after endovascular interventions. Materials and Methods: From 2016 to 2017, a pilot study was performed using the ProGlide to achieve hemostasis after percutaneous access of distal brachial arteries >4 mm in diameter. In an interim analysis, the results were compared to a matched control group taken from a 60-patient historical cohort who underwent brachial artery access and manual compression to achieve hemostasis between 2014 and 2017. The primary outcome was access-related reintervention and the secondary outcome was the incidence of access-site complications. Results: Seven patients (mean age 67.9 years; 6 men) were enrolled in the study before it was stopped in 2017. Four patients experienced 6 access-site complications (neuropathy, hematoma, occlusion, and pseudoaneurysm). These resulted in 3 access-related reinterventions: surgical evacuation of a hematoma, thrombectomy of the occluded brachial artery, and surgical repair of the pseudoaneurysm. In the interim comparison to the 19 matched patients (mean age 61.9 years; 6 men), the ProGlide group had proportionally more patients experiencing access-related complications (57% vs 16% for manual compression, p=0.035) and resultant reinterventions (43% vs 11%, p=0.064). Based on this data the trial was stopped. Conclusion: Considering this experience, it is not advisable to use the ProGlide in transbrachial endovascular interventions due to the high incidence of complications and access-related reinterventions.

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Identifying bioethical issues in biostatistical consulting: findings from a US national pilot survey of biostatisticians

BMJ Open ◽

10.1136/bmjopen-2017-018491 ◽

2017 ◽

Vol 7 (11) ◽

pp. e018491 ◽

Cited By ~ 2

Author(s):

Min Qi Wang ◽

Alice F Yan ◽

Ralph V Katz

Keyword(s):

Pilot Study ◽

Sample Size ◽

Random Sample ◽

Phase Ii ◽

Phase Ii Study ◽

Secondary Outcome ◽

Perceived Severity ◽

Severity Scores ◽

Bioethical Issues ◽

Second Tier

ObjectivesThe overall purposes of this first US national pilot study were to (1) test the feasibility of online administration of the Bioethical Issues in Biostatistical Consulting (BIBC) Questionnaire to a random sample of American Statistical Association (ASA) members; (2) determine the prevalence and relative severity of a broad array of bioethical violations requests that are presented to biostatisticians by investigators seeking biostatistical consultations; and (3) establish the sample size needed for a full-size phase II study.DesignA descriptive survey as approved and endorsed by the ASA.ParticipantsAdministered to a randomly drawn sample of 112 professional biostatisticians who were ASA members.Primary and secondary outcome measuresThe 18 bioethical violations were first ranked by perceived severity scores, then categorised into three perceived severity subcategories in order to identify seven ‘top tier concern violations’ and seven ‘second tier concern violations’.ResultsMethodologically, this phase I pilot study demonstrated that the BIBC Questionnaire, as administered online to a random sample of ASA members, served to identify bioethical violations that occurred during biostatistical consultations, and provided data needed to establish the sample size needed for a full-scale phase II study. The No. 1 top tier concern was ‘remove or alter some data records in order to better support the research hypothesis’. The No. 2 top tier concern was ‘interpret the statistical findings based on expectation, not based on actual results’. In total, 14 of the 18 BIBC Questionnaire items, as judged by a combination of ‘severity of violation’ and ‘frequency of occurrence over past 5 years’, were rated by biostatisticians as ‘top tier’ or ‘second tier’ bioethical concerns.ConclusionThis pilot study gives clear evidence that researchers make requests of their biostatistical consultants that are not only rated as severe violations, but further that these requests occur quite frequently.

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Implementation of Foodcare a Hospital Nutritional Care Concept: A Pilot Study

10.21203/rs.3.rs-118281/v1 ◽

2020 ◽

Author(s):

Nanna Møller Lykkegaard Rasmussen ◽

Alexander Erichsen ◽

Allan Stubbe Christensen ◽

Kirstine Guld Frederiksen ◽

Signe Loftager Okkels ◽

...

Keyword(s):

Pilot Study ◽

Protein Intake ◽

Intervention Group ◽

Fixed Time ◽

Randomised Control Trial ◽

Control Group ◽

Nutritional Care ◽

Time Points ◽

On Demand ◽

Medical Inpatients

Abstract Background: Different attempts have been made to improve nutritional care and food intake in hospital inpatients. One way may be to improve the individual customisation of meals and meal time points. This pilot study compared the food concept FoodCare consisting of customised meals served on demand and standardised meals served at fixed time points concerning energy and protein intake in medical inpatients. Method: A pilot study including medical lung inpatients at a Danish regional hospital. The control group received a set menu with limited choices served at fixed times. The intervention group received a menu of customised dishes prepared by food professionals and served on demand. Results: Twelve patients were included in the control group and 26 patients in the intervention group. In the intervention group, the tendency showed an increased energy (8.8 ± 2.7 MJ (mean ± SD) compared with the control group of 7.3 ± 2.0 MJ, p=0.10) and protein intake (74 ± 26 grams compared with the control group of 60 ± 18 (mean ± SD) grams, p=0.08). Conclusion: This pilot study demonstrated that a self-selected menu served on demand may potentially increase energy and protein intake in medical inpatients. The concept should be further tested in a randomised control trial with a sufficient sample size.

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Efficacy and safety of Guduchighan Vati in asymptomatic and mild to moderate cases of COVID-19: A randomized controlled pilot study

10.31219/osf.io/c8f9h ◽

2021 ◽

Author(s):

Umesh Shukla ◽

Nitin Ujjaliya ◽

Pankaj Gupta ◽

Vivek Khare ◽

Babita Yadav ◽

...

Keyword(s):

Adverse Drug Reaction ◽

Adverse Event ◽

Drug Reaction ◽

Pilot Study ◽

Sample Size ◽

Intervention Group ◽

T Test ◽

Control Group ◽

Rt Pcr ◽

Randomized Controlled

Background: Currently, there is no approved treatment for the management of COVID-19 pandemic. Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19.Objectives: To determine the clinical effectiveness and safety profile of an Ayurveda Intervention (Guduchighan Vati) in asymptomatic and mild to moderate cases of COVID-19.Methods: This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19. Guduchighan Vati 500 mg twice daily for 10 days was administered in the intervention group as standalone therapy and Hydroxychloroquine in the control group.Outcome measures: Time to negative RT-PCR for COVID-19, proportion of participants turned RT-PCR negative for COVID-19 at 5th and 10th day, duration to achieve complete clinical recovery, improvement in laboratory parameters and incidence of Adverse Drug Reaction/Adverse Event. The data was compared within group using paired sample t-test/ Wilcoxon signed rank test and between group using independent sample t-test/Mann-Whitney test. The results of RT-PCR test was compared between group using chi-square test.Results: 93.3% participants turned RT-PCR negative for COVID-19 in the intervention group, as compared to 66.6% participants in control group till 10th day of the study period. However, the results are statistically insignificant (p = 0.068) which might be attributed to smaller sample size. All the symptomatic patients in the intervention group were clinically recovered at 5th day whereas 14 out of 15 recovered in the control group. No symptoms were observed at 10th day in both the groups. No adverse drug reaction/serious adverse event were observed during the study period.Conclusion: Guduchighan Vati is a safe and effective treatment for asymptomatic and mild cases of COVID-19 and it lowers the time to RT-PCR negative status without any adverse drug reaction/adverse event.

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Endothelial-Dependent Vasodilation Is Impaired in Children with Sickle Cell Disease (SCD).

Blood ◽

10.1182/blood.v108.11.3778.3778 ◽

2006 ◽

Vol 108 (11) ◽

pp. 3778-3778

Author(s):

Mariane De Montalembert ◽

Yacine Aggoun ◽

Assa Niakate ◽

Isabelle Szezepanski ◽

Damien Bonnet

Keyword(s):

Steady State ◽

Carotid Artery ◽

Common Carotid Artery ◽

Vascular Function ◽

Intima Media Thickness ◽

Control Group ◽

The Common ◽

Dependent Flow ◽

And Gender ◽

Flow Mediated Vasodilation

Abstract Impairment of endothelium-dependent vasodilation has been reported in steady-state SCD adult patients, and could contribute to the occurrence of vaso-occlusive events. In order to study whether vascular tone abnormalities could be also observed in SCD children, we enrolled 21 SCD steady-state children (18 homozygous SS, 3 S-b0 thalassemics); 12 males, 9 females, mean aged 10.4 ± 3.3 yrs, mean Hb level: 7.6 ± 1.0 g/dL. None had had a transfusion in the 3 previous months, nor were treated with hydroxyurea. These SCD children were compared to a control group of 23 Afro-Caribbean AA and AS controls matched for age and gender. Blood pressure and vascular function parameters were measured after the child had been recumbent for at least 10 minutes. Flow-mediated (FMD) and nitroglycerine-mediated (GTNMD) dilation of the brachial artery were examined in cases and controls using echotracking techniques. Additionally, intima-media thickness (IMT) and mechanical properties of the common carotid artery were measured using previously described methods. Blood pressures in SCD and control children were comparable. IMT was not different in SCD children (0.42 ± 0.06 mm) vs controls (0.42 ± 0.03 mm). Systolic and diastolic diameters of the common carotid artery were significantly higher in SCD children than in controls (respectively, 6.8 ± 0.8 vs 5.7 ± 0.4, p<0.001, and 5.7 ±0.7 vs 5.0 ± 0.4 mm, p< 0.005) but the stiffness of the common carotid artery was not different in SCD children and in controls. Finally, FMD was significantly decreased in SCD children vs controls (5.6 ± 0.2 vs 8.0 ± 0.2 %, p: 0.008), while GTNMD was comparable in SCD patients and controls. We hypothesize that the increase of the carotid artery diameters, without modification of the distensibility, is related to the higher cardiac output secondary to anemia. Interestingly, we observed a significant decrease of the endothelial-dependent flow-mediated vasodilation in SCD children, which had never been reported before. This could result of impaired NO bioavailability, correlated with enhanced arginase activity and hemolysis rate. Oral arginine supplementation in SCD children could be an appropriate treatment.

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Effect of Umbilical Cord Milking on Severity of Hypoxic Ischemic Encephalopathy in Asphyxiated Neonates A Pilot study

10.1101/2021.05.26.21257569 ◽

2021 ◽

Author(s):

Roshith J Kumar ◽

Manoj Varanattu

Keyword(s):

Pilot Study ◽

Umbilical Cord ◽

Primary Outcome ◽

Tertiary Care ◽

Hypoxic Ischemic Encephalopathy ◽

Secondary Outcome ◽

Control Group ◽

Case Group ◽

Ischemic Encephalopathy ◽

Umbilical Cord Milking

Background: The present study was aimed to evaluate the effect of umbilical cord milking technique on severity of Hypoxic Ischemic Encephalopathy (HIE) in asphyxiated neonates and assessed by Modified Sarnats staging as primary outcome, APGAR score at 5 minutes and Respiratory support requirement as secondary outcome. Methods: This was a randomized, controlled pilot study conducted in neonatology department at a tertiary care centre, Thrissur, Kerala. The neonates were divided into two groups non milking group, control (n=38) and umbilical cord milking, case [UCM] (n=32) and their outcomes were compared. In the intervention group, the cord was cut at 30 cm from umbilical stump within 30 seconds of birth and euthermia was maintained. The umbilical cord was raised and milked from the cut end towards the infant 3 times with speed at 10 cm/sec and then clamped 2 to 3 cm from the umbilical stump. In the control group, the umbilical cord was clamped without doing cord milking. Results: In this study moderate to severe HIE were less in case group 46.9 % than control group 55.1% and less neonates 44.7 % had Mild HIE in control group compared to case group 53.1% even though result was statistically not significant as primary outcome (p value not significant). Eight neonates (21.6%) in control group had Apgar at 5 min score 0 to 3, whereas only 4 (12.5%) neonates in cord milking group. Conclusions: The insufficient knowledge of placental transfusion limits and benefits leads to a wide variation in the management of cord clamping. It would be useful to standardise the UCM procedure in order to offer protocols applicable to clinical practice, and to spread knowledge among professionals through educational programs.

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Weekly versus Daily Iron Supplementation for Preventing Iron deficiency Anaemia Amongst Children Between Six to 24 Months: A Randomised Control Trial

Journal of Nepal Paediatric Society ◽

10.3126/jnps.v39i3.28272 ◽

2019 ◽

Vol 39 (3) ◽

pp. 174-180

Author(s):

Sneha Kaushik ◽

Anita Yadav ◽

Pradeep Kumar Debata ◽

Kailash Chandra Aggarwal

Keyword(s):

Iron Deficiency ◽

Serum Ferritin ◽

Iron Deficiency Anaemia ◽

Iron Supplementation ◽

Tertiary Care ◽

Intervention Group ◽

Randomised Control Trial ◽

Secondary Outcome ◽

Control Group ◽

Deficiency Anaemia

Introduction: Iron deficiency anaemia is common in developing nations and starting iron supplementation from infancy is an important measure for its prevention. There is still not enough evidence, whether giving iron twice weekly as compared to daily, is enough to prevent the same. Methods: This open-labeled randomised control trial was conducted at a tertiary care facility over a period of 1.5 years. After informed consent from parents, a total of 125 non-anaemic healthy infants in age group six to 24 months; with birth weight > 2500 grams, born singleton at term gestation and predominantly breastfed in the first six months of life; were randomised using computer generated sequence to two groups. Control group received daily elemental iron supplementation of 1 mg/kg/day and the intervention group received twice weekly 2 mg/kg/day. Haemoglobin, serum ferritin were measured at enrolment and at the end of 100 days. Primary outcome was anaemia defined as haemoglobin less than 11 mg/dl. Secondary outcome measures were weight gain, increase in length and occipito-frontal circumference. Results: Baseline characteristics were similar in the two groups. This study showed significantly higher mean haemoglobin (mg/dl) (mean ± SD 11.882 ± 0.3237, 11.683 ± 0.4264, p = 0.009) and mean serum ferritin (ng/ml) (mean ± SD 101.704 ± 23.0263, 62.149 ± 24.2079, p = 0.000) at end of 100 days in the control group than the intervention group. There was no difference in any of the secondary outcomes. Conclusions: Biweekly iron supplementation can also prevent iron deficiency anaemia in children between six to 24 months of age but daily is better in respect to the increase in haemoglobin.

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Somatocognitive therapy of women with provoked vulvodynia: a pilot study

Scandinavian Journal of Pain ◽

10.1515/sjpain-2019-0011 ◽

2019 ◽

Vol 19 (4) ◽

pp. 725-732

Author(s):

Gro Killi Haugstad ◽

Slawomir Wojniusz ◽

Rolf Kirschner ◽

Unni Kirste ◽

Ingvild Lilleheie ◽

...

Keyword(s):

Psychological Distress ◽

Standard Deviation ◽

Pilot Study ◽

Secondary Outcome ◽

Controlled Study ◽

Control Group ◽

Average Standard Deviation ◽

Motor Functions ◽

Pain Experience

Abstract Background and aims Provoked vestibulodynia (PVD) is a common persistent pain state among women in the Western world, causing dyspareunia, psychological distress and challenges against fertility. Therapies aimed at relieving pain (physiotherapy) and psychological distress (psychotherapy) are often recommended, sometimes in multimodal combinations. We have previously developed somatocognitive therapy (SCT) as a multimodal intervention, administered by a physiotherapist, to a different group of patients with gynecological pain, i.e. chronic (unprovoked) pelvic pain (CPP, also referred to as low abdominal pain). In a randomized, controlled study this intervention was shown to reduce pain experience and improve motor function or body awareness. Here we present the results of a clinical follow-up pilot study with 30 women with PVD, applying SCT administered by third year bachelor students in physiotherapy. Main outcome was pain experience, secondary outcomes were psychological distress and motor functions of the patients. Methods Thirty women diagnosed with PVD were recruited from a tertiary university hospital clinic of gynecology, and included in the follow-up pilot study at an out-patient physiotherapy clinic. Each patient participated in 10–14 therapy sessions over 6 weeks. The students were supervised by an experienced physiotherapist with extensive background in this clinical area, who also performed two clinical sessions with each of the patients at the end of the treatment period. Before therapy, the patients were evaluated for pain experience (visual analogue scale of pain, VAS), psychological distress (Tampa scale of kinesiophobia, TSK) and General Health Questionnaire (GHQ-30) as well as body function (standardized Mensendieck test, SMT). Statistical analyzes were performed by using the average ± standard deviation, statistical significance of changes calculated by means of the t-test. Results Average pain score before therapy were 7.77 ± 1.98, after 6 weeks of intervention 4.17 ± 2.07 and at 6 months’ follow-up 1.66 ± 1.08 (average ± standard deviation), changes being significant below p < 0.01 level. Secondary outcome variables assessing psychological distress and sub optimal motor patterns were also significantly improved. For example, anxiety and depression scores were reduced by approximately 40%, and respiration pattern score improved by almost 80%. Conclusions Multimodal somatocognitive therapy reduced levels of pain and psychological distress, and improved motor functions in women with PVD after 6 weeks of interventions. All variables were further improved at 6 months’ follow-up. Thus, somatocognitive therapy may be a useful treatment option for patients with PVD. However, there are limitations to this study, since there was no control group, and suboptimal blinding during assessment of the data. Implications Somatocognitive therapy may be a useful tool when treating PVD patients. More studies, in particular RCTs, should be performed to further evaluate this intervention and corroborate the results from this pilot study.

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Medical Qigong for Cancer Patients: Pilot Study of Impact on Quality of Life, Side Effects of Treatment and Inflammation

The American Journal of Chinese Medicine ◽

10.1142/s0192415x08005904 ◽

2008 ◽

Vol 36 (03) ◽

pp. 459-472 ◽

Cited By ~ 50

Author(s):

Byeongsang Oh ◽

Phyllis Butow ◽

Barbara Mullan ◽

Stephen Clarke

Keyword(s):

Quality Of Life ◽

Pilot Study ◽

Side Effects ◽

Cancer Treatment ◽

Medical Care ◽

Sample Size ◽

Cancer Patients ◽

Intervention Group ◽

Control Group

Quality of life (QOL) of cancer patients is often diminished due to the side effects of treatment and symptoms of the disease itself. Medical Qigong (coordination of gentle exercise and relaxation through meditation and breathing exercise based on Chinese medicine theory of energy channels) may be an effective therapy for improving QOL, symptoms and side effects, and longevity of cancer patients. In this pilot study, the feasibility, acceptability, and impact of Medical Qigong (MQ) were evaluated on outcomes in cancer patients. Thirty patients diagnosed with heterogeneous cancers, were randomly assigned to two groups: a control group that received usual medical care and an intervention group who participated in a MQ program for 8 weeks in addition to receiving usual medical care. Randomization was stratified by completion of cancer treatment ( n = 14) or under chemotherapy ( n = 16). Patients completed measures before and after the program. Quality of life and symptoms were measured by the EORTC QLQ-C 30 and progress of disease by the inflammation biomarker (CRP: c-reactive protein) via a blood test was assessed. The MQ intervention group reported clinically significant improved global QOL scores pre- and post-intervention. The MQ intervention also reduced the symptoms of side effects of cancer treatment and inflammation biomarker (CRP) compare to the control group. Due to the small sample size, however, the results were not statistically significant between treatment and the control groups. Data from the pilot study suggest that MQ with usual medical treatment can enhance the QOL of cancer patients and reduce inflammation. This study needs a further investigation with a larger sample size.

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