title
stringlengths
1
1.19k
keywords
stringlengths
0
668
concept
stringlengths
0
909
paragraph
stringlengths
0
61.8k
PMID
stringlengths
10
11
4. Discussion
low back pain, tachycardia, faintness, palpitations, pain, CM, disability, strokes
CHRONIC LOW BACK PAIN, HEART, DISEASES, STROKES
A wide variety of treatment methods have been used for CMLBP over the years.There are several factors that negatively affect the results of this study. Precautions were taken when planning the study to avoid negatively affecting results.First, the “minimization” method used for randomization ensured that the participan...
PMC10101266
5. Conclusion
CM, pain
As a result of this study, CM and CTM had almost similar effects on all parameters. They improved the participants very well, and the effects continued at the end of the 6-week follow-up. Although CTM is the first choice for modulating autonomic responses and CM for pain, we found that both massages were as effective. ...
PMC10101266
Abbreviations:
MECHANICAL LOW BACK PAIN
Classical massageChronic mechanical low back painConnective tissue massageOswestry disability indexPittsburgh sleep quality indexShort form 36Visual analog scaleThe datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.The authors have no fu...
PMC10101266
References
PMC10101266
1. Introduction
SAM, B12 deficiency, malnutrition
BLOOD, MALNUTRITION
Severe acute malnutrition (SAM) is treated with ready-to-use therapeutic foods (RUTF) containing a vitamin–mineral premix. Yet little is known about micronutrient status in children with SAM before and after treatment. We aimed to investigate vitamin B12 status in children with uncomplicated SAM, aged 6–59 months in Bu...
PMC10458940
2. Materials and Methods
PMC10458940
2.1. Study Design and Settings
This study was based on data from the Modeling an Alternative Nutrition Protocol Generalizable to Outpatient care (MANGO) trial for which the methodology is described in detail elsewhere [
PMC10458940
2.2. Study Participants
Children with SAM were admitted to the trial based on anthropometric entry criteria of a mid-upper arm circumference (MUAC) <115 mm, and/or weight-for-height z-score (WHZ) <−3 [
PMC10458940
2.3. Intervention
Malnutrition, death
MALNUTRITION
Treatment of children with SAM followed the Burkina Faso national Community-based Management of Acute Malnutrition (CMAM) guidelines [Children were followed weekly until discharge and were classified as recovered, referred, non-response, defaulting, lost to follow-up, death, or false discharge [
PMC10458940
2.4. Data Collection
Socio-demographic characteristics were collected at admission, anthropometry and 2-week retrospective morbidity were collected at each visit [
PMC10458940
2.5. Blood Sampling and Storage
Venous blood was collected in Vacutainer
PMC10458940
2.6. Biochemical Analyses
Serum B12 was determined with microbiological assay based on a colistin sulphate-resistant strain of
PMC10458940
2.7. Data Management
All preparation and statistical analyses were performed using Stata version 17 (Stata Corp, Texas, USA). Anthropometric z-scores were calculated using the 2006 World Health Organization (WHO) growth standards [
PMC10458940
2.8. Data Analyses
±, acute illness
REGRESSION
Population characteristics were reported as proportion, means ± standard deviation (SD), or median with Inter Quartile Range (IQR) (25th- and 75th-percentiles) as appropriate, with corresponding group size. Right-skewed outcomes were log-transformed prior to analysis and estimates were back-transformed. The baseline ch...
PMC10458940
2.9. Ethical Considerations
This study was approved by the National Ethics Committee of Burkina Faso (deliberation number 2015-12-00) and the national clinical trials board of Burkina Faso (Direction Générale de la Pharmacie, du Médicament et des Laboratoires (DGPML)). The trial was registered in the International Standard Randomized Controlled T...
PMC10458940
3. Results
PMC10458940
3.1. Characteristics of Children in Vitamin B12 Sub-Study
MINOR
Of the 801 children included in the MANGO trial, 374 (47%) were included in the B12 sub-study: 180 from the reduced and 194 from the standard RUTF arm (There was no difference at baseline in demographic characteristics between the children included in the B12 biomarker sub-study compared to those not included from the ...
PMC10458940
3.2. Biomarkers of Vitamin B12 Status in Children with SAM Treated with RUTF
B12 deficiency
At admission, only 16% showed a 3cB12 value indicating adequate B12 status (3cB12 > 0), while 32% had 3cB12 values suggesting marked to severe B12 deficiency (3cB12 < −1.4) (The following cut-points for 3cB12 were employed for the classification of B12 status: adequate if >0, moderate deficiency when ≥−1.4 but ≤0, mark...
PMC10458940
3.3. Vitamin B12 Biomarkers with a Reduced or a Standard RUTF Dose
No differences at admission or discharge in B12 biomarkers and response were observed according to intervention (a reduced or a standard RUTF dose) (
PMC10458940
3.4. Factors Associated with B12 Status
diarrhea
Factors or indicators potentially associated with vitamin B12 status, indicated by 3cB12, at admission and discharge are presented in At admission, children with diarrhea had higher B12 status (
PMC10458940
4. Discussion
pernicious anemia, B12 deficiency, cognitive impairment, Deficiencies, toxicity, diarrhea, cognitive and psychomotor development
PERNICIOUS ANEMIA, IRON DEFICIENCY ANEMIA
To our knowledge, this study is the first to describe biomarkers of vitamin B12 status in children with SAM before and after outpatient treatment. Low concentrations of serum B12 alongside elevated serum tHcy and MMA were observed at admission with only 16% of children deemed to have adequate B12 status according to th...
PMC10458940
4.1. Strengths and Limitations
The original MANGO study was not designed to investigate changes in vitamin B12 status specifically. However, this sub-study included three individual biomarkers of B12 status as well as a composite score (3cB12). The 3cB12 composite score is considered to give a better judgment of B12 status than use of the individual...
PMC10458940
4.2. Generalizability
Our findings are, to a certain extent, generalizable to children with SAM of comparable age in other low-income countries with similar socioeconomic conditions, and where the food habits are comparable. Food groups most consumed by children in our study were grains, roots or tubers (96%), and legumes and nuts (72%) [
PMC10458940
5. Conclusions
breast-fed, anemia, IDA
ANEMIA
Children with SAM presented with a low B12 status, as judged by 3cB12, and generalized deficiencies (IDA and anemia) at admission to treatment. However, treatment with RUTF significantly improved B12 status though it did not normalize 3cB12 in all children. Reduction of the RUTF dose did not impact the final status of ...
PMC10458940
Supplementary Materials
The following supporting information can be downloaded at: Click here for additional data file.
PMC10458940
Author Contributions
A.B., L.T., H.F.
Conceptualization, V.N., S.T.K. and C.S.; methodology, V.N., S.T.K., C.S., A.B., L.T., H.F., C.R., E.N. and A.M.; laboratory method development and biological sample analysis: E.N., A.M.; software, V.N. and E.N.; validation, V.N., S.T.K., C.S., A.B., L.T., H.F., C.R., E.N. and A.M.; formal analysis, V.N.; investigation...
PMC10458940
Institutional Review Board Statement
This study was conducted in accordance with the Declaration of Helsinki. This study was approved by the national Ethics Committee of Burkina Faso (deliberation number 2015-12-00) and the national clinical trials board of Burkina Faso (Direction Générale de la Pharmacie, du Médicament et des Laboratoires (DGPML)). The t...
PMC10458940
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10458940
Data Availability Statement
Data of this study has been attached as a
PMC10458940
Conflicts of Interest
The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.
PMC10458940
Objectives:
IBD
INFLAMMATORY BOWEL DISEASE
Physical activity programs have been suggested as adjunctive therapy in adult inflammatory bowel disease (IBD) patients. We assessed the effects of a 12-week lifestyle intervention in children with IBD.
PMC10348627
Methods:
IBD, fatigue
DISEASE
This study was a randomized semi-crossover controlled trial, investigating a 12-week lifestyle program (3 physical training sessions per week plus personalized healthy dietary advice) in children with IBD. Endpoints were physical fitness (maximal and submaximal exercise capacity, strength, and core stability), patient-...
PMC10348627
Results:
Fifteen patients (median age 15 [IQR: 12–16]) completed the program. At baseline, peak VO
PMC10348627
What Is Known
IBD
INFLAMMATORY BOWEL DISEASE
Children with inflammatory bowel disease (IBD) have decreased levels of physical activity compared to healthy peers.Physical activity programs have been suggested as adjunctive therapy in adult IBD patients.
PMC10348627
What Is New
ulcerative colitis, fatigue, Crohn disease, UC, IBD
INFLAMMATORY BOWEL DISEASE, ULCERATIVE COLITIS, DISEASE, CROHN DISEASE, CHRONIC INFLAMMATORY DISEASE, REMISSION
This study shows that a 12-week tailored physical training program including healthy dietary advice resulted in an increased submaximal exercise capacity and core stability, improved parent and self-reported quality of life, and less parent-reported fatigue.The intervention also seemed to have a positive effect on IBD ...
PMC10348627
METHODS
MAY
This was a prospective single-center randomized semi-crossover controlled trial, conducted between December 2019 and May 2021 at the Department of Pediatric Gastroenterology at Erasmus MC—Sophia Children’s Hospital in Rotterdam, The Netherlands. The trial was registered in the Dutch trial register:
PMC10348627
Ethical Approval Statement
Erasmus MC
The study was performed in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Erasmus MC Medical Centre (NL.70912.078.19) and registered at
PMC10348627
Patient Consent Statement
All patients and parents signed informed consent.
PMC10348627
Clinical Trial Registration
Erasmus MC
Ethics Committee of Erasmus MC Medical Centre (NL.70912.078.19), and registered at
PMC10348627
Participants
IBD, UC
Children, aged 6–8 years, with a diagnosis of IBD (CD, UC, or IBD-unclassified) confirmed by ileocolonoscopy and upper endoscopy with histology on multiple mucosal biopsies were eligible for enrollment. Exclusion criteria were: children with a physical inability to perform a cardiopulmonary exercise test (CPET), partic...
PMC10348627
Study Design and Intervention
Ulcerative Colitis, Crohn disease, Fatigue
CROHN DISEASE, ULCERATIVE COLITIS
Figure Study design and visits and measurement assessments. 6MWT = 6-minute walking test; BODPOD = body composition measurement system; CF = child form; CHQ = child health questionnaire; CPET = cardiopulmonary exercise test; MFS = Multidimensional Fatigue Scale; PCDAI = Pediatric Crohn disease Activity Index; PF = pare...
PMC10348627
Outcome Measurements
fatigue
DISEASE
The primary study endpoint was the change in maximal exercise capacity measured by peak oxygen uptake (peak VOSecondary study endpoints included:(1) Physical fitness: submaximal exercise capacity, muscle strength, motor function, core stability, psychical activity levels.(2) Patient-reported outcomes: quality of life, ...
PMC10348627
Physical Fitness
PMC10348627
Exercise Capacity
Exercise capacity was assessed by maximal CPET and submaximal CPET using an electric brake bicycle ergometer, and a 6-minute walking test (6MWT). Details regarding CPET protocols can be found in our previously published exercise study protocol (
PMC10348627
Muscle Strength and Core Stability
All muscle strength measurements were performed in a standardized manner by either L.J.G. or L.E.S. using hand-held dynamometry and compared to normal values of Beenakker et al (
PMC10348627
Physical Activity Levels
During the consultation with the sports physician, children and parents were asked about the amount of time spent on physical activity a week. Subsequently, physical activity levels were measured with a validated Actigraph GT3X+ accelerometer (firmware v3.2.1, ActiGraph Inc, Pensacola, FL) (
PMC10348627
Patient-Reported Outcomes
PMC10348627
Quality of Life, Fatigue, and Fear of Exercise
The validated child health questionnaire (CHQ) child form (CF) and parent form (PF) and the pediatric IBD-specific IMPACT-III questionnaire were used to assess health-related quality of life before and after the intervention (
PMC10348627
Clinical Disease Activity
Crohn disease, Ulcerative Colitis
DISEASE, CROHN DISEASE, ULCERATIVE COLITIS
To assess the effects of the intervention program on disease activity fecal calprotectin, laboratory measurements [c-reactive protein (CRP), erythrocyte sedimentation rate (ESR)], and clinical disease activity scores [Pediatric Crohn disease Activity Index (PCDAI) or Pediatric Ulcerative Colitis Activity Index (PUCAI)]...
PMC10348627
Nutritional Status
PMC10348627
Body Composition, Intake, and Energy Balance
Patient’s height and weight were measured, and body composition was assessed using a skinfold caliper (4 skinfolds method) and air displacement plethysmography on whole-body densitometry using the BOD POD (
PMC10348627
Sample Size Calculation and Statistical Analysis
IBD
In a previous Dutch study, untrained children with IBD had a mean peak VO
PMC10348627
RESULTS
PMC10348627
Patient Characteristics
Crohn Disease, Ulcerative Colitis
DISEASE, CROHN DISEASE, ULCERATIVE COLITIS
In total 50 subsequent patients visiting the clinic were asked to participate in the study by L.E.S. Given reasons not to participate were lack of time due to school obligations (n = 24), far distance from the hospital (n = 5), already performing sports 3 times a week (n = 3), and personal reasons (n = 2). A total of 1...
PMC10348627
Physical Fitness
PMC10348627
Exercise Capacity
Peak VOExercise capacityValues are shown as median [IQR]; effect size is shown with 95% confidence interval. 6MWT = 6-minute walking test; CPET = cardiopulmonary exercise test; HR = heart rate; kg = kilogram; Max = maximal; min = minutes; mL = millilitres; VO
PMC10348627
Core Stability and Muscle Strength
Core stability improved significantly compared to the control period (
PMC10348627
Physical Activity Levels
Five out of 16 children participated in sports activities before the COVID-19 lockdown. None of the children had to quit sports activities due to IBD-related symptoms earlier (<3 months). Median percentage of time spent in moderate-to-very vigorous activity measured with the Actigraph was 12.1% at baseline; this is bel...
PMC10348627
Patient-Reported Outcomes
PMC10348627
Quality of Life, Fatigue, and Fear of Exercise
multi fatigue, Fatigue
Quality of life, measured by the IBD-specific IMPACT-III questionnaire, improved on 4 domains out of 6 domains compared to the control period with an effect size of +13 points on the total score (Table IMPACT-III and multi fatigue dimension scaleValues are shown in mean ± SD or as median [IQR]. MFS = Multidimensional F...
PMC10348627
Clinical Disease Activity
DISEASE
No disease exacerbations were observed during the training period.
PMC10348627
Nutritional Status
PMC10348627
Body Composition and Energy Balance
Median measured REE was increased (+14%) compared to healthy peers (
PMC10348627
DISCUSSION
IBD, fatigue
DISEASE
This study is the first to investigate the effects of a lifestyle intervention on a broad set of outcomes in children with IBD. The lifestyle intervention resulted in improved physical fitness, quality of life, and parent-reported fatigue and also seemed to have a positive effect on the IBD as suggested by the lower cl...
PMC10348627
Physical Fitness
PMC10348627
Exercise Capacity
At baseline, peak VO
PMC10348627
Physical Activity Levels
The intervention did not increase physical activity levels measured with the Actigraph. This might be related to measurement timing since baseline measurements were performed before the COVID-19 pandemic and post-intervention measurements. In addition, children might have taken some time off from exercise during the we...
PMC10348627
Patient-Reported Outcomes
PMC10348627
Quality of Life, Fatigue, and Fear of Exercise
depression, fatigue, IBD, anxiety
Children and adolescents with IBD experience decreased quality of life, increased anxiety and depression, and more fatigue compared to healthy peers (
PMC10348627
Clinical Disease Activity
IBD
DISEASE, REMISSION
After the lifestyle program, PCDAI scores and thereby number of patients in remission decreased significantly. This was mainly declared by a decrease in self-reported bowel symptoms on the PCDAI/PUCAI. Fecal calprotectin decreased, but not compared to the control period, mainly due to relatively large intra-patient flu...
PMC10348627
Nutritional Status
muscle mass
DISEASE
Although most children did not consume sufficient calories according to their food diaries, growth was comparable to healthy peers. Body fat measured over the control period (by both skinfold and BODPOD; body composition system, COSMED, Ltd, Concord, CA) decreased, leading to a significantly higher body fat percentage ...
PMC10348627
Strengths and Limitations
weakness, IBD
MUCOSAL INFLAMMATION, DISEASE, REMISSION
Our study has several strengths. This study is the first to prospectively investigate the effects of a lifestyle intervention in pediatric IBD patients on a broad set of outcomes, which are never investigated before in this population. The program was well received, as reflected by the high training adherence, making t...
PMC10348627
CONCLUSIONS
IBD, fatigue
INTESTINAL INFLAMMATION, DISEASE
The 12-week lifestyle intervention resulted in improved physical fitness, quality of life, and parent-reported fatigue. In addition, a combination of lower clinical disease activity scores accompanied by fewer IBD symptoms suggests positive effects on intestinal inflammation. Children and adolescents with IBD should be...
PMC10348627
Acknowledgments
DER
We would like to thank all patients for participating in our trial and all physiotherapists for training the patients. Abir Bougrine & The Rotterdam Exercise Team: W.A. Helbing, M.W. Pijnenburg, A.T. van der Ploeg, J. Noske, A. van den Broek, and J. Olieman.
PMC10348627
Supplementary Material
J.C.E. received institutional research support from MSD, AbbVie, and Janssen. L.E.M.v.d.B. has received research support from “Maag Darm Lever Stichting,” “Stichting Vrienden van Sophia,” and the “Beatrix spierfonds.” The remaining authors report no conflicts of interest.Supplemental digital content is available for th...
PMC10348627
REFERENCES
PMC10348627
1. Introduction
MP, Stunting
STUNTING
These authors contributed equally to this work.Stunting affects 22% children globally, putting them at risk of adverse outcomes including delayed development. We investigated the effect of milk protein (MP) vs. soy and whey permeate (WP) vs. maltodextrin in large-quantity, lipid-based nutrient supplement (LNS), and LNS...
PMC10301406
2. Materials and Methods
PMC10301406
2.1. Study Design
MP
SECONDARY
This study reports secondary outcomes from the MAGNUS trial, a community-based randomized 2 × 2 factorial trial assessing the role of MP and WP in LNS on growth and development among stunted children (ISRCTN13093195). The primary outcome of the original trial was the effect of the intervention on height and knee-heel l...
PMC10301406
2.2. Study Participants
disability, oedema, malnutrition
MILK ALLERGIES, MEDICAL COMPLICATION, OEDEMA, MALNUTRITION
This study was conducted at two public health facilities in Walukuba division and Buwenge town council in Jinja district. The district is located about 75 km east of the capital city Kampala forming part of the ten districts in the Busoga sub-region in East-Central Uganda.Study participants were identified from the sur...
PMC10301406
2.3. Randomization, Allocation Concealment and Blinding
As described previously [All investigators and outcome assessors were blinded with respect to LNS or no LNS, and to the ingredients contained in the differently coded LNS sachets. Caregivers and children were blinded with respect to the type of LNS allocated since all the four supplements were indistinguishable in appe...
PMC10301406
2.4. The Intervention
All caregivers, irrespective of study arm, received nutrition counselling at inclusion, in line with the national policy on infant and young child feeding [Compliance to LNS intake was measured by counting returned empty sachets and asking the caregiver how many sachets the child had consumed since the last visit. Miss...
PMC10301406
2.5. Study Visits
All caregivers returned fortnightly to collect LNS or laundry soap until the 12th week. Distribution took place in a closed room only after all other on-site study activities were completed for the participant. At baseline, data on the following were collected: demographic information, dietary intake including breastfe...
PMC10301406
2.6. Sample Size Consideration
MP
This was based on the primary outcome of the main trial (height and knee-heel length) where detecting 0.35 SD or a greater difference in any outcome between any of the two groups, at 5% significance level and 80% power, while allowing for 10% attrition, allowed us to recruit 150 children per group (600 in total based o...
PMC10301406
2.7. Outcomes
Child development, the main outcome of the current study, was assessed using the Malawi development assessment tool (MDAT) version 6 [Head circumference (mm) was measured in triplicate using a windowed, nonelastic paper-head circumference tape (SECA 212, Hamburg, Germany), in line with accepted international standards ...
PMC10301406
2.8. Additional Data
The child and caregiver’s participation during the MDAT assessment was observed by the CDO. This was evaluated based on an adapted version of the Behaviour Observation Inventory from the Bayley Scales of Infant and Toddler Development [The child’s developmental stimulation at home was assessed using an African validate...
PMC10301406
2.9. Statistical Analyses
fits, MP, stunting, inflammation
INFLAMMATION
Paper case report forms were used to collect data, which were then doubly entered in EpiData with inbuilt range checks before uploading to REDCap (Open-Source Vanderbilt University) to a secure server at UCPH weekly. Data comparison was performed and any discrepancies were verified by both entrants with the aid of the ...
PMC10301406
2.10. Ethics
This study was approved by the Makerere University School of Medicine Research and Ethics Committee (#REC REF 2019-013) and the Uganda National Council of Science and Technology (SS 4927). We also obtained consultative approval from the Danish National Committee on Biomedical Research Ethics (1906848). All study staff ...
PMC10301406
3. Results
PMC10301406
3.1. Participant Characteristics
±
Between February and September 2020, we screened 7611 children at various village sites. Of these, 1193 were stunted, 750 of whom were enrolled and randomized into one of five groups (At inclusion, the median [interquartile range, IQR] age was 30 [23; 41] months, 45% (338) were girls, and the mean ± SD HAZ was −3.02 ± ...
PMC10301406
3.2. Development among the Unsupplemented Children
Over the 12-week follow-up period, there were increments in developmental scores across all domains among the un-supplemented children (
PMC10301406
3.3. Main Effect of Milk Ingredients and/or LNS on Development
MP
The primary intention-to-treat analysis assessed the effects of MP and WP based on the factorial design among the 600 children who received LNS. There was no interaction between MP and WP for any of the outcomes (
PMC10301406
3.4. Subgroup Effect of Milk Ingredients, and LNS in Itself, on Development
MP, stunting
INFLAMMATION
We assessed whether the effects of MP and WP were modified by sex, breastfeeding, stunting severity, baseline inflammation, and a stimulative home environment. The effect of MP on social skills was modified by sex and breastfeeding (interaction, The effect of MP on cognition was modified by a stimulative home environme...
PMC10301406
4. Discussion
MP
INFLAMMATION, CURB, MALNUTRITION
In our nutrition intervention study using large-quantity LNS, neither MP nor WP had an effect on any development domain or head circumference. Irrespective of milk ingredients, LNS vs. no supplementation had no effect on any development domain but seemed to increase head circumference. A further test for interactions r...
PMC10301406
Supplementary Materials
The following supporting information can be downloaded at: Click here for additional data file.
PMC10301406
Author Contributions
The authors’ contributions were as follows: H.F., B.G., E.M., H.P., J.M. and R.M. designed the study; H.P., B.G., H.F., E.M., J.M. and R.M. wrote the protocol; H.F. and E.M. were principal investigators; J.M., R.M., H.P. and B.G. implemented the study and E.M., J.M., H.P., R.M. and B.G. supervised data collection. The ...
PMC10301406
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and was approved by the Makerere University School of Medicine Research and Ethics Committee (#REC REF 2019-013) and the Uganda National Council of Science and Technology (SS 4927). We also got consultative approval from the Danish National Committe...
PMC10301406
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10301406
Data Availability Statement
The Ugandan act on Data Protection and Privacy and the European act on General Data Protection Regulation do not allow for personal data to be made available to other researchers without prior written approval from relevant institutions and authorities. For further information, please contact the corresponding author.
PMC10301406
Conflicts of Interest
H.F. and C.M. have received research grants from ARLA Food for Health. H.F., B.G. and C.M. have received research grants from the Danish Dairy Research Foundation. C.M. and K.F.M. also received funds from Arla Foods Amba and finally H.F., C.M., K.F.M., B.G., S.F. and A.B. have had research collaboration with Nutriset, ...
PMC10301406