Study Protocol of the Exercise Study: Unraveling Limitations for Physical Activity in Children With Chronic Diseases Order to Target Them With Tailored Interventions—A Randomized Cross Over Trial

Introduction: Physical activity is associated with many physiological and psychological health benefits across the lifespan. Children with a chronic disease often have lower levels of daily physical activity, and a decreased exercise capacity compared to healthy peers. In order to learn more about limitations for physical activity, we investigate children with four different chronic diseases: children with a Fontan circulation, children with Broncho Pulmonary Dysplasia (BPD), Pompe disease and inflammatory bowel disease (IBD). Each of these diseases is likely to interfere with physical activity in a different way. Knowing the specific limitations for physical activity would make it possible to target these, and increase physical activity by a personalized intervention. The aim of this study is to first investigate limitations for physical activity in children with various chronic diseases. Secondly, to measure the effects of a tailored exercise intervention, possibly including a personalized dietary advice and/or psychological counseling, on exercise capacity, endurance, quality of life, fatigue, fear for exercise, safety, muscle strength, physical activity levels, energy balance, and body composition.Methods and Analysis: This randomized crossover trial will aim to include 72 children, aged 6–18 years, with one of the following diagnosis: a Fontan circulation, BPD, Pompe disease and IBD. Eligible patients will participate in the 12-week tailored exercise intervention and are either randomized to start with a control period or start with the intervention. The tailored 12-week exercise interventions, possibly including a personalized dietary advice and/or psychological counseling, will be designed based on the found limitations for physical activity in each disease group during baseline measurements by the Rotterdam Exercise Team. Effects of the tailored training interventions will be measured on the following endpoints: exercise capacity (measured by cardiopulmonary exercise test), endurance, physical activity levels, muscle strength, quality of life, fatigue, fear for exercise, disease activity, cardiac function (in children with a Fontan circulation), energy balance, and body composition.Ethics and Dissemination: Conducted according to the Declaration of Helsinki and Good Clinical Practice. Medical-ethical approval was obtained.Trial Registration Number: NL8181, https://www.trialregister.nl/trial/8181.

Effects of paternal overnutrition and interventions on future generations

In the last two decades, evidence from human and animal studies suggests that paternal obesity around the time of conception can have adverse effects on offspring health through developmental programming. This may make significant contributions to the current epidemic of obesity and related metabolic and reproductive complications like diabetes, cardiovascular disease, and subfertility/infertility. To date, changes in seminal fluid composition, sperm DNA methylation, histone composition, small non-coding RNAs, and sperm DNA damage have been proposed as potential underpinning mechanism to program offspring health. In this review, we discuss current human and rodent evidence on the impact of paternal obesity/overnutrition on offspring health, followed by the proposed mechanisms, with a focus on sperm DNA damage underpinning paternal programming. We also summarize the different intervention strategies implemented to minimize effects of paternal obesity. Upon critical review of literature, we find that obesity-induced altered sperm quality in father is linked with compromised offspring health. Paternal exercise intervention before conception has been shown to improve metabolic health. Further work to explore the mechanisms underlying benefits of paternal exercise on offspring are warranted. Conversion to healthy diets and micronutrient supplementation during pre-conception have shown some positive impacts towards minimizing the impact of paternal obesity on offspring. Pharmacological approaches e.g., metformin are also being applied. Thus, interventions in the obese father may ameliorate the potential detrimental impacts of paternal obesity on offspring.

A Visualization Analysis of Hotspots And Frontiers of Cardiovascular Diseases With Frailty Based On CiteSpace

Cardiovascular diseases(CVD) and frailty are common health problems among the elderly. This research aims to investigate the hotspots and frontiers of the field of cardiovascular diseases with frailty. Data of publications between 2000 and 2021 was collected from the Web of Science(WoS) and CiteSpace was used for analysing the hotspots and frontiers of cardiovascular diseases with frailty research from high-impact countries, institutions, authors, cited-references, cited-journals, high-frequency keywords and burst keywords. The results showed that the United States, England and Canada were the leading countries in research of cardiovascular diseases with frailty. Other countries and regions lagged behind these developed countries. There is a need to establish cooperation between developed countries and developing countries. Research hotspots focused on frailty in the elderly with CVD, exercise intervention, assessment for CVD patients with frailty, quality of life and common diseases related to CVD with frailty. The frontier fields include care and intervention of CVD patients with frailty, social frailty and validation of CVD with frailty.

Effects of exercise-based prehabilitation in children undergoing elective surgeries: a systematic review

Background: Prehabilitation is a therapeutic strategy involving preoperative physical exercises, nutritional support, and stress and anxiety reduction. This approach has been gaining popularity and has been seeing effective results in adults in terms of improving pre and postoperative outcomes. The purpose of this review was to summarise the evidence about the effects of exercise-based prehabilitation programs on various outcome measures in children post elective surgeries.­­ Methods: PubMed, Scopus, Web of Science, PEDro, CINAHL/EBSCO and EMBASE electronic databases were searched from inception to June 2021. Based on the inclusion criteria, titles and abstracts were independently screened by the authors. After that, a data extraction table of the selected studies which included the participants, type, and details of exercise intervention, outcome measures and results were analysed after which the quality assessment of the studies was done. Results: The search yielded 2219 articles of which three articles fulfilled the inclusion criteria with two studies being randomized controlled trials and one being a quasi-experimental pre-post type of study. One randomized controlled trial was on the effects of exercise-based prehabilitation in reducing pulmonary complications post cardiac surgeries in children and the other two studies were on the effects of prehabilitation on functional capacity & pulmonary function. All the three articles found that exercise-based prehabilitation had a positive effect on children’s post-surgery. Conclusion: Although there is a paucity of evidence-based literature, we conclude based on the existing literature retrieved by our review that exercise-based prehabilitation improves postoperative outcomes and helps in reducing postoperative complications in children undergoing various surgeries.

Circulating Long-Chain Acylcarnitine Concentrations are Not Affected by Exercise Training in Pregnant Women with Obesity

The purpose of this study was to determine the effect of exercise during pregnancy in sedentary women with obesity on longitudinal changes in long-chain acylcarnitine (LC-AC) concentrations. We hypothesized that exercise training would significantly decrease circulating LC-ACs throughout gestation compared to a non-exercise control group. Pregnant women with obesity considered otherwise healthy [n=80, mean ± SD; body mass index (BMI): 36.9±5.7 kg/m2] were randomized into an exercise (n=40, aerobic/resistance 3x/week, ~13th gestation week until birth) or a non-exercise control (n=40) group. At gestation week 12.2 ± 0.5 and 36.0 ± 0.4, a submaximal exercise test was conducted, and indirect calorimetry was used to measure relative resting energy expenditure (REE), as well as respiratory exchange ratio (RER) at rest. Fasting blood samples were collected and analyzed for LC-AC concentrations. Fitness improved with prenatal exercise training; however, exercise training did not affect circulating LC-AC. When groups were collapsed, LC-ACs decreased during gestation (combined groups, P < 0.001), whereas REE (kcal·kg-1·d-1, P = 0.008) increased. However, average REE relative to FFM (kcal·kgFFM-1·d-1) and RER did not change. There was an inverse relationship between the change in RER and all LC-ACs (except C18:2) throughout gestation (C14: r = -0.26, P = 0.04; C16: r = -0.27, P = 0.03; C18:1: r = -0.28, P = 0.02). In summary, a moderate intensity exercise intervention during pregnancy in women with obesity did not alter LC-ACs concentrations versus control, indicating that the balance between LCFA availability and oxidation neither improved nor worsened with an exercise intervention.

Effects of nutritional intervention by feeding high-protein foods containing BCAA for improving locomotive syndrome: Randomized Controlled Trial

[Purpose] Exercise guidance is an effective measure against locomotive syndrome. Appropriate nutritional management is also considered necessary in order to maintain the motor function. This study is the first exploratory and prospective research on the effects of exercise guidance and feeding high-protein foods in order to improve locomotive syndrome, in elderly people. [Method] We conducted a survey regarding five items related to locomotorium on the basic checklist prepared by the Japanese Ministry of Health, among men and women in their 60s and over living in Miyazaki Prefecture. Participation was solicited from those who responded “applicable” to three or more items, with those who gave their consent assigned to a food + exercise intervention group (EF group), an exercise intervention group (EX group), and a control group (C group) for research. Motor function surveys such as interviews, questionnaire, and locomotive syndrome risk test were conducted at the start of the study and three months later. The EX and EF groups were instructed to carry out locomotion training, while the EF group was asked to ingest one bag of high-protein test food daily immediately following exercise. The participants carried an activity meter and kept a record of their life in a diary during the study period. The EX and EF groups were encouraged to make recordings in a diary and carry an activity meter, while also getting a regular telephone contact once a week. [Results] An improvement in the motor function was observed in the EX and EF group compared to the C group via Locomotive syndrome risk testing. While the muscle mass decreased significantly during the study period in the C and EX group, no significant change was observed in limbs/trunk muscle mass in the EF group. [Conclusion] The locomotion training improved the results of the Locomotive syndrome risk testing. Although muscle mass decreased with exercise guidance alone, muscle mass loss was suppressed by feeding high-protein foods in addition to exercise. We conclude that feeding high-protein foods is useful for improving motor function and maintaining muscle mass, in addition to exercise guidance, as a measure against locomotive syndrome in elderly.

Greater Reduction of Blood Pressure with Exercise Intervention Than Standard Care After Recent Ischaemic Atroke: A Randomized Clinical Trial

Context and Objectives: Ischaemic stroke (IS) causes disability and uses massive public health resources. Cumulative disability from recurrence may be reduced with cardiometabolic risk reduction strategies e.g., lowering blood pressure (BP). We hypothesized that intensive exercise plus best available care in adults with recent IS improves fitness, glucose metabolism, muscle protein synthesis in paretic limbs compared to controls. BP changes were compared between intervention (INT) and controls (CON). Research Design and Setting: A randomised, interventional clinical trial conducted in Jamaican adults subjects: We investigate 103 adults with recent IS and residual weakness. Forty-nine subjects (24 women: mean age 61.5; 25 men: mean age 63.8) received task-oriented exercise training (TEXT) plus best available care. Fifty-four subjects (23 women: mean age 60.2; 31 men: mean age 61.3) received best care, including exercise advice. Measurements: We measured baseline, 3-month and 6-month BP. Results: After recent IS, TEXT plus best available care reduced systolic BP by 21 mmHg and diastolic by 12 mmHg compared to controls, independent of medication adherence, body composition; stroke severity. Men in the TEXT group had increased lean mass (P < 0.007), VO2 max (P = 0.03); 6-minute walk distance (P = 0.003). Leg press on paretic (P = 0.004) and non-paretic (P < 0.001) increased with TEXT vs CON over 6 months, in both sexes (P-values for sex difference > 0.2). Time-to-chair-rise decreased in both sexes who received intervention vs controls (P <0.04) Conclusions: TEXT results in significant blood pressure reduction in adults with recent ischaemic stroke and residual weakness when compared with best available medical care only.

Effect of different conditioning methods of traditional Chinese health exercise on lung function in healthy middle-aged and elderly people: study protocol for a randomized controlled trial

Background Lung function is highly age-dependent as it decreases in varying degrees with age, even in healthy people. Decreased lung function results in less elastic lung tissue, reduced chest wall compliance, reduced area for gas exchange, and even a variety of chronic diseases. Traditional Chinese health exercise (TCHE) has three components: “breath regulation,” “body regulation,” and “heart regulation,” which play an important role in the improvement of lung function. However, which component has the most significant effect on lung functioning remains unclear. Therefore, depending on the modality of conditioning, TCHEs will be divided into three exercise intervention groups: breath regulation group, body regulation group, and heart regulation group, in order to explore the magnitude of the effect of the different modalities of conditioning on the improvement of lung function. Methods The prospective, parallel, single-blind, randomized controlled trial will evaluate the effects of different conditioning methods of TCHE on lung function in middle-aged and elderly people. The study subjects are healthy middle-aged and elderly adults, who will be randomly divided into the “breath regulation group,” “body regulation group,” “heart regulation group,” and “control group.” The control group will receive health education. Health education and exercise intervention in the three intervention groups will be provided for 6 months, 5 times a week, with each session lasting 60 min. The outcomes of interest include changes in the pulmonary function tests measured at baseline and 3 and 6 months after the beginning of the intervention. The primary outcome is the forced vital capacity (FVC), while the secondary outcomes include forced expiratory volume in 1 s (FEV1), FVC/FEV1 ratio, vital capacity (VC), and maximal voluntary ventilation (MVV). Discussion This study will assess the effects of different conditioning methods of TCHE on lung function in middle-aged and elderly people. The final findings of this study will validate the effectiveness and safety of TCHE on lung function interventions in middle-aged and elderly people. Trial registration China Clinical Trial Registry ChiCTR2100052687. Registered on November 3, 2021

Fit for purpose. Co-production of complex behavioural interventions. A practical guide and exemplar of co-producing a telehealth-delivered exercise intervention for people with stroke

Background Careful development of interventions using principles of co-production is now recognized as an important step for clinical trial development, but practical guidance on how to do this in practice is lacking. This paper aims (1) provide practical guidance for researchers to co-produce interventions ready for clinical trial by describing the 4-stage process we followed, the challenges experienced and practical tips for researchers wanting to co-produce an intervention for a clinical trial; (2) describe, as an exemplar, the development of our intervention package. Method We used an Integrated Knowledge Translation (IKT) approach to co-produce a telehealth-delivered exercise program for people with stroke. The 4-stage process comprised of (1) a start-up planning phase with the co-production team. (2) Content development with knowledge user informants. (3) Design of an intervention protocol. (4) Protocol refinement. Results and reflections The four stages of intervention development involved an 11-member co-production team and 32 knowledge user informants. Challenges faced included balancing conflicting demands of different knowledge user informant groups, achieving shared power and collaborative decision making, and optimising knowledge user input. Components incorporated into the telehealth-delivered exercise program through working with knowledge user informants included: increased training for intervention therapists; increased options to tailor the intervention to participant’s needs and preferences; and re-naming of the program. Key practical tips include ways to minimise the power differential between researchers and consumers, and ensure adequate preparation of the co-production team. Conclusion Careful planning and a structured process can facilitate co-production of complex interventions ready for clinical trial. Graphical Abstract

Potential value of home square-stepping exercises for inactive older adults: an exploratory case study

Background Most older adults do not engage in regular physical activity. However, more research on options to partake in regular exercise in this population by reducing barriers and enhancing enablers while still reaching benefits is needed. Methods Using embedded mixed methods, 10 inactive older adults over the age of 65 completed a 3-week square-stepping exercise intervention to help overcome the initial barriers and activate initial enablers to perform regular exercise. Physical activity level was tracked at home with a pedometer using median steps/day over seven days for pre-post measure. Aerobic intensity while doing square-stepping exercises was quantified via a heart rate monitor in a supervised session. Each participant had an interview asking about barriers and enablers to regular exercise and if the intervention could modify any. Based on initial physical activity a framework matrix was used to pull potential barriers to compare, contrast, and search for patterns between participants with lower and higher initial physical activity levels. Results The 3-week square-stepping exercise intervention helped participants overcome barriers such as being uncomfortable in a fitness facility and body image and activate enablers such as the use of home equipment and convenience. The median total steps/day increased by 12% (p = 0.02), and a moderate-intensity level was reached by 80% of the sample participants when performing the square stepping exercise during a supervised session. Common barriers such as having a suitable program, hard to keep the intensity were reported by participants regardless of the initial physical activity level. Conclusion Regardless of initial physical activity level, inactive older adults can increase physical activity level at the recommended intensity and overcome common barriers to exercise when performing square-stepping exercises, especially for those intimidated by a fitness facility setting and those concerned with their body image. A longer intervention including more participants using the square-stepping exercises is required to understand if square-stepping exercises can increase the proportion of older adults exercising regularly.