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Promoting healthy teenage behaviour across three European countries through the use of a novel smartphone technology platform, PEGASO fit for future: study protocol of a quasi-experimental, controlled, multi-Centre trial.
Puigdomenech, E, Martin, A, Lang, A, Adorni, F, Gomez, SF, McKinstry, B, Prinelli, F, Condon, L, Rashid, R, Caon, M, et al
BMC medical informatics and decision making. 2019;(1):278
Abstract
BACKGROUND Behaviour change interventions targeting physical activity, diet, sleep and sedentary behaviour of teenagers show promise when delivered through smartphones. However, to date there is no evidence of effectiveness of multicomponent smartphone-based interventions. Utilising a user-centred design approach, we developed a theory-based, multi-dimensional system, PEGASO Fit For Future (PEGASO F4F), which exploits sophisticated game mechanics involving smartphone applications, a smartphone game and activity sensors to motivate teenagers to take an active role in adopting and maintaining a healthy lifestyle. This paper describes the study protocol to assess the feasibility, usability and effectiveness (knowledge/awareness and behavioural change in lifestyle) of the PEGASO system. METHODS We are conducting a quasi-experimental controlled cluster trial in 4 sites in Spain, Italy, and UK (England, Scotland) over 6 months. We plan to recruit 525, in a 2:1 basis, teenagers aged 13-16 years from secondary schools. The intervention group is provided with the PEGASO system whereas the comparison group continues their usual educational routine. Outcomes include feasibility, acceptance, and usability of the PEGASO system as well as between and within group changes in motivation, self-reported diet, physical activity, sedentary and sleeping behaviour, anthropometric measures and knowledge about a healthy lifestyle. DISCUSSION PEGASO F4F will provide evidence into the cross-cultural similarities and differences in the feasibility, acceptability and usability of a multi-dimensional smartphone based behaviour change intervention for teenagers. The study will explore facilitating factors, challenges and barriers of engaging teenagers to adapt and maintain a healthy lifestyle when using smartphone technology. Positive results from this ICT based multi component intervention may have significant implications both at clinical level, improving teenagers health and at public health level since it can present an influential tool against the development of chronic disease during adulthood. TRIAL REGISTRATION https://clinicaltrials.gov Registration number: NCT02930148, registered 4 October 2016.
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Persistent Impairment in Cardiopulmonary Fitness after Breast Cancer Chemotherapy.
Foulkes, SJ, Howden, EJ, Bigaran, A, Janssens, K, Antill, Y, Loi, S, Claus, P, Haykowsky, MJ, Daly, RM, Fraser, SF, et al
Medicine and science in sports and exercise. 2019;(8):1573-1581
Abstract
PURPOSE Anthracycline chemotherapy (AC) is associated with acute reductions in cardiopulmonary fitness (V˙O2peak). We sought to determine whether changes in V˙O2peak and cardiac function persisted at 12 months post-AC completion, and whether changes in cardiac function explain the heightened long-term heart failure risk. METHODS Women with breast cancer scheduled for AC (n = 28) who participated in a nonrandomized trial of exercise training (ET; n = 14) or usual care (UC; n = 14) during AC completed a follow-up evaluation 12 months post-AC completion (16 months from baseline). At baseline, 4 months, and 16 months, participants underwent a resting echocardiogram (left ventricular ejection fraction; global longitudinal strain), a blood sample (troponin; B-type natriuretic peptide), a cardiopulmonary exercise test, and cardiac MRI measures of stroke volume (SV), heart rate, and cardiac output (Qc) at rest and during intense exercise. RESULTS Seventeen women (UC, n = 8; ET, n = 9) completed evaluation at baseline, 4 months, and 16 months. At 4 months, AC was associated with 18% and 6% reductions in V˙O2peak in the UC and ET groups, respectively, which persisted at 16 months (UC, -16%; ET, -7%) and was not attenuated by ET (interaction, P = 0.10). Exercise Qc was lower at 16 months compared with baseline and 4 months (P < 0.001), which was due to a blunted augmentation of SV during exercise (P = 0.032; a 14% reduction in peak SV), with no changes in heart rate response. There was a small reduction in resting left ventricular ejection fraction (baseline to 4 months) and global longitudinal strain (between 4 and 16 months) and an increase in troponin (baseline to 4 months), but only exercise Qc was associated with V˙O2peak (R = 0.47, P < 0.01). CONCLUSION Marked reductions in V˙O2peak persisted 12 months after anthracycline-based chemotherapy, which was associated with impaired exercise cardiac function. CLINICAL TRIAL REGISTRATION ACTRN12616001602415.
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The impact of exercise training on the lipid peroxidation metabolomic profile and respiratory infection risk in older adults.
Silva, D, Arend, E, Rocha, SM, Rudnitskaya, A, Delgado, L, Moreira, A, Carvalho, J
European journal of sport science. 2019;(3):384-393
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Abstract
UNLABELLED Aging is associated with oxidative stress that may increase susceptibility to respiratory infections (RIs). We aimed to assess the impact of exercise training on the risk of RIs in older adults and on a targeted metabolomic profile of stress oxidative lipid peroxidation-related metabolites. METHODS In an 8-month clinical trial, 38 participants over 60 years of age were allocated to an exercise group (EG), in which participants underwent 90-min training sessions three times/week(n = 20), or a control group (CG), in which participants maintained daily physical activities(n = 18). Daily respiratory symptoms and RIs number and severity were collected. Serum by-products were assessed by comprehensive two-dimensional gas chromatography coupled to mass spectrometry with time of flight analyzer. Serum metabolomic profiling comprised 76 metabolites (alcohols, aldehydes, alkanes, and ketones). Principal components analysis and ANOVA-simultaneous component analysis were used to evaluate the metabolomic profile change. RESULTS The odds ratio of RIs for the EG was 2.0 CI 95% [0.2;25]. The incidence of RIs was 47% [23;70] in the EG vs. 44%[12;77] in the CG. The metabolomic profiling showed that alkanes and aldehydes classes differed between the EG and the CG before and after intervention. A calibration model showed a relation between the metabolites from four main classes (ketones, alcohols, alkanes and aldehydes) and the prediction of the number of RIs. CONCLUSION Moderate exercise training, in older adults, compared with no exercise in controls, did not show a difference in the risk of RIs. A pattern of lipid peroxidation was associated with the number of RIs.
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Effectiveness of a Parent-led Physical Activity Intervention in Youth with Obesity.
Rubin, DA, Wilson, KS, Dumont-Driscoll, M, Rose, DJ
Medicine and science in sports and exercise. 2019;(4):805-813
Abstract
PURPOSE Prader-Willi syndrome (PWS) is a complex, rare neurobehavioral syndrome characterized by excessive fat, hypotonia, poor motor skills, and behavioral and cognitive disabilities. We tested the effectiveness of a home-based physical activity (PA) intervention led by parents in youth with obesity with and without PWS to increase moderate-to-vigorous PA (MVPA) and gross motor proficiency. METHODS Participants were 111 youth age 8 to 16 yr (45 with PWS and 66 without PWS, but categorized as obese). A parallel design was used with the control group (C) receiving the intervention after serving as control. Intervention participants (I) completed a PA curriculum 4 d·wk for 24 wk including warm-up exercises, strengthening exercises, and playground games 2 d·wk and interactive console games 2 d·wk guided by their parents. Pre-post outcomes (baseline to 24 wk) included MVPA (7-d accelerometry) and motor proficiency including upper limb coordination, bilateral coordination, balance, running speed and agility, and muscle strength (Bruininks-Oseretsky Test of Motor Proficiency). RESULTS The intervention led to no change in MVPA (I group, 39.6 vs 38.9 min·d; C group, 40.6 vs 38.3 min·d). The intervention led to improvements in body coordination (22.3%; P < 0.05), as well as strength and agility (13.7%; P < 0.05). Specifically, the I group showed increases in upper limb coordination (19.1%), bilateral coordination (27.8%), and muscle strength (12.9%; P < 0.05 for all) not observed in the C group: -0.2%, 2.5%, and -3.2%, respectively. CONCLUSIONS This parent-guided PA intervention did not increase PA. However, the intervention led to improvements in gross motor skill competency. Providing families with tools and support can lead to implementation of PA routines that contribute to motor skill proficiency in youth with and without PWS.
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Self-Directed Oral Vitamin D Supplementation in Professional Ballet Dancers: A Randomized Controlled Trial Pilot Study.
Rowan, FE, Benjamin-Laing, H, Kennedy, A, De Medici, A, Beasley, I, Haddad, FS
Journal of dance medicine & science : official publication of the International Association for Dance Medicine & Science. 2019;(3):91-96
Abstract
Inadequate levels of vitamin D may lead to poor performance in professional dancers. Therefore, dietary supplementation may be essential in this population. This longitudinal pilot study to a randomized controlled trial assessed dancer compliance with self-directed oral vitamin D supplementation. Seventy-one dancers, 41 females and 30 males with a mean age of 31.1 years, were recruited from The Royal Ballet, London. Baseline serum 25(OH)D levels were measured and dancers were interviewed, examined, and provided with oral supplements for the winter period, November 2011 to March 2012. Dancers with normal serum 25(OH)D levels were provided with maintenance supplements (1,000 IU/ day) and those with insufficient or deficient serum 25(OH)D levels were given a loading dose of 60,000 IU weekly for 2 and 6 weeks, respectively. Serum 25(OH) D levels were measured at 1 and 2 years and dancers were sampled for compliance with instructions. Mean compliance during loading and maintenance was 86% and 50%, respectively. Mean serum 25(OH)D levels at start and end of the study period were 79.3 ± 31.6 nmol/L and 78.68 ± 19.8 nmol/L, respectively. Only one-third of dancers with insufficient (N = 5) and deficient (N = 5) serum vitamin D levels improved to normal values. It is concluded that professional ballet dancers demonstrate good compliance with self-directed loading doses of vitamin D supplementation but poor compliance with maintenance doses. Poor maintenance compliance may have accounted for the low rates of serum vitamin D level improvement among dancers with insufficient or deficient levels.
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Background and evaluation design of a community-based health-promoting school intervention: Fit Lifestyle at School and at Home (FLASH).
van Dongen, BM, Ridder, MAM, Steenhuis, IHM, Renders, CM
BMC public health. 2019;(1):784
Abstract
BACKGROUND A community-based approach can be a promising strategy for implementing school-based health promotion aimed at stimulating healthy physical activity and dietary behaviour. Such an approach builds on the community capacity of multiple stakeholders, empowering them to design and implement tailored activities, supported by the whole school community. This paper describes the background and evaluation design of the community-based school intervention 'Fit Lifestyle at School and at Home' (FLASH) in four prevocational schools. FLASH includes four strategies for building the community capacity of students, school personnel and parents: 1) identifying leaders in each stakeholder group, 2) stimulating a school culture of participation, 3) having stakeholders design and implement tailored activities and 4) creating a network of local partners for structural embedding. The objective is to monitor the capacity-building processes of the FLASH intervention and to explore if these processes contribute to changes in community capacity. In addition, we will explore if the FLASH intervention is related to changes in PA, dietary behaviours and BMI of students. METHODS This study has a mixed methods design and uses a participatory action-oriented approach to monitor and evaluate changes in community capacity, tailored health-promotion activities and implementation processes. Methods include semi-structured interviews, focus groups, journals, document analysis and observational scans of the physical environment. In addition, changes in BMI, physical activity and dietary behaviours of prevocational students will be explored by comparing the four intervention schools to four control schools. Data are collected by questionnaires and anthropometric measurements. DISCUSSION The main strength of this study is its use of mixed methods to evaluate real-life processes of creating a healthy-school community. This will provide valuable information on capacity-building strategies for the structural embedding of health-promotion activities within school settings. The results could help schools become more empowered to adapt and adopt integral health-promotion interventions in daily practice that suit the needs of their communities, that are expected to be sustainable and that could lead to favourable changes in the PA and dietary behaviour of students. TRIAL REGISTRATION ISRCTN67201841 ; date registered: 09-05-2019, retrospectively registered.
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Ectoine lozenges in the treatment of acute viral pharyngitis: a prospective, active-controlled clinical study.
Dao, VA, Overhagen, S, Bilstein, A, Kolot, C, Sonnemann, U, Mösges, R
European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2019;(3):775-783
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Abstract
PURPOSE Acute pharyngitis is an uncomfortable disorder mostly caused by viruses and for which antibiotics are unwarranted. This study compared lozenges containing ectoine, a natural extremolyte, with hyaluronic acid lozenges and hypertonic saline gargle for symptomatic treatment of acute viral pharyngitis. METHODS This prospective, controlled clinical study, recruited 90 patients with moderate-to-severe pharyngitis symptoms who chose to use either ectoine (n = 35), hyaluronic acid (n = 35), or saline gargle (n = 20). Patients applied their 7-day treatment from the inclusion visit (V1) until the end-of-study visit (V2). Patients' pharyngitis symptoms, general health, general treatment effectiveness and tolerability, and patient compliance were assessed by investigators and patients. RESULTS The sum score for three primary symptoms (pain on swallowing, urge to cough, and hoarseness) decreased by 79.5% (ectoine), 72.2% (hyaluronic acid), and 44.8% (saline gargle). Both lozenges were significantly superior to saline gargle (P < 0.05). Regarding general health improvement, ectoine was significantly superior to saline gargle (72.5% vs. 45.2%, P < 0.05), but hyaluronic acid (63.3%) was not. At V2, 65.7% of patients receiving ectoine reported "very good" general health vs. 48.6% of those receiving hyaluronic acid and 20.0% using saline gargle. Ectoine was significantly superior (P < 0.05) to both hyaluronic acid and saline gargle in terms of tolerability and patient compliance. No patients taking ectoine reported unpleasant sensations while applying their treatment, whereas almost half of patients using hyaluronic acid lozenges and saline gargle did. CONCLUSION Treatment with ectoine lozenges significantly relieves moderate-to-severe symptoms of acute viral pharyngitis and is more effective and tolerable than treatments with hyaluronic acid lozenges and hypertonic saline gargle.
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Bone-anchored maxillary protraction in patients with unilateral complete cleft lip and palate and Class III malocclusion.
Ren, Y, Steegman, R, Dieters, A, Jansma, J, Stamatakis, H
Clinical oral investigations. 2019;(5):2429-2441
Abstract
OBJECTIVE This prospective controlled study evaluated the effect of bone-anchored maxillary protraction therapy in cleft children with Class III malocclusion using CBCT-derived 3D surface models. MATERIALS AND SUBJECTS Eighteen cleft patients between 10 and 12 years old were included. Intermaxillary elastics were worn after the placement of four zygoma bone plates for 18 months. Uniquely, three age-matched untreated groups including both cleft subjects and non-cleft subjects with Class III malocclusion served as controls. Profile photos and CBCT scans for each patient were taken before (T0) and 18 months after the protraction (T1). 3D measurements were made on CBCT surface models from the treatment group using tomographic color mapping method. Cephalometric measurements were made on lateral cephalogram reconstructed from the CBCT scans and were compared with those obtained from the control groups. RESULTS Two thirds of the treatment subjects showed improved lip projection towards more convex facial profile. The most significant skeletal changes on 3D surface models were observed at the zygomatic regions (mean 1.5-mm forward, downward, and outward displacement) and at the maxillary complex (mean 1.5-mm forward displacement). Compared with the control groups, the treatment subjects showed significant increase in the SNA and ANB angles, increased Wits appraisal, a more forward movement of point A and overjet improvement (p < 0.05). CONCLUSIONS BAMP in cleft patients gives a significant forward displacement of the zygomaxillairy complex in favor of the Class III treatment. CLINICAL RELEVANCE This treatment method shows clearly favorable outcome in cleft patients after 1.5 years of BAMP.
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Multicenter, Prospective, Controlled Double-Blind Study Comparing Fib-19-01, A Phytotherapy Treatment, To A Dietary Supplement And To Conventional Care In Patients Suffering From Fibromyalgia.
Barmaki, M, Maindet-Dominici, C, Nizard, J, Baron, D, Russ, I, Fardellone, P, Ginies, P, Marc, JF, Conrozier, T, Bertin, P
Alternative therapies in health and medicine. 2019;(4):46-53
Abstract
BACKGROUND Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory results and new approaches have to be explored. OBJECTIVES To assess efficacy and safety of adding a phytotherapy treatment (Fib-19-01) to the current therapeutic regimen in patients with FM. METHODS Double-blind controlled trial: women with active FM (Fibromyalgia Index Questionnaire FIQ > 40) were randomised to receive Fib-19-01 or a food supplement (FS) undistinguishable from Fib-19-01 or no supplementary treatment (NoST). All continued the conventional therapy throughout the 6 month follow-up. Primary endpoint: change in FIQ between Day 0 and month 6 (M6). Secondary Criteria: variation over time FIQ ( repeated measurements), change in Pichot fatigue scale, Pittsburgh Sleep Quality Index (PSQI), SF-12 and Hospital Anxiety and Depression (HAD) scales. RESULTS 100 patients (Intent-To-Treat population) were analyzed. FIQ decreased significantly only in the Fib-19-01 group (P < .001) at both week 12 and 24. Improvement was higher for Fib-19-01 (-13.4 ± 18.9) than in the 2 other groups (-5.5 ± 15.6 and -5.6 ± 11.3) despite there was no statistical between-group difference at week 24 in FIQ score (P = .08 and P = .09 respectively). Analysis of variance in repeated measurements of FIQ showed a significant difference between Fib-19-01 and FS throughout the follow-up period (P = .03). Fib-19-01 was superior to both FS and NoST for Pichot scale decrease over time: -4.6 (range -6.9; -2.28), -0.29 (-2.7; 2.1) and -0.72 (-3.1; 1.66) (P = .013 and 0.023 respectively), mental and social SF12 [+8.1 (range 3.5; 12.6), -0.27(range -5.3; 4.8 ) and -0.02 (range -5.0; 4.9 ) P = .02 and 0.018)],HAD depression [-2.0 (range -3.3; -0.7), +0.5 (range -0.9; 1.9 ) and +0.71 (range -0.7; 2.1) P = .013 and 0.007]. No significant difference was found between FS and NoST groups for any outcome. All treatments were well and similarly tolerated. CONCLUSIONS In patients with FM taking conventional therapy, Fib-19-01 has a therapeutic effect on fatigue, emotion and social life, and depression associated with the disease.
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Impacts of dance on cognition, psychological symptoms and quality of life in Parkinson's disease.
Kalyani, HHN, Sullivan, KA, Moyle, G, Brauer, S, Jeffrey, ER, Kerr, GK
NeuroRehabilitation. 2019;(2):273-283
Abstract
BACKGROUND While dance may improve motor features in Parkinson's disease (PD), it is not yet clear if the benefits extend to non-motor features. OBJECTIVE To determine whether dance classes based on Dance for PD®, improve cognition, psychological symptoms and Quality of Life (QoL) in PD. METHODS Participants were allocated to a Dance Group (DG; n = 17) or Control Group (CG: n = 16). Participants had early-stage PD (Hoehn & Yahr: DG = 1.6±0.7, CG = 1.5±0.8) with no cognitive impairment (Addenbrooke's score: DG = 93.2±3.6, CG = 92.6±4.3). The DG undertook a one-hour class, twice weekly for 12 weeks, while the CG had treatment as usual. Both groups were assessed for disease severity (MDS-UPDRS), cognition (NIH Toolbox® cognition battery, Trail Making Test), psychological symptoms (Hospital Anxiety and Depression Scale, MDS-UPDRS-I) and QoL (PDQ-39, MDS-UPDRS-II). RESULTS Group comparison of pre-post change scores showed that selected cognitive skills (executive function and episodic memory), psychological symptoms (anxiety and depression) as well as QoL (PDQ-39 summary index) were significantly improved by the intervention (DG > CG, p's < 0.05, Cohen's d > 0.8). DISCUSSIONS AND CONCLUSION Dance classes had a clear benefit on psychological symptoms, QoL and a limited cognitive benefit. Follow-up assessment is required to confirm the durability of these effects.