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A 12-Week Pilot Exercise Program for Inactive Adults With Celiac Disease: Study Protocol.

ABSTRACT: Background:Individuals with celiac disease must follow a strict gluten-free diet (GFD) in order to avoid negative short- and long-term health consequences. Unfortunately, many people with celiac disease report poor quality of life (QoL) despite following a strict GFD, and up to 30% still report negative symptoms (eg, gastrointestinal upset). Purpose:The purpose of the MOVE-C (understanding the relationship between the MicrobiOme, Vitality, and Exercise in Celiac disease) pilot study is to explore the effects of a 12-week supervised progressive high-intensity interval training (HIIT) and lifestyle intervention on physiological, behavioral, and psychosocial outcomes among inactive adults with celiac disease.Methods/Design: Sixty inactive adults diagnosed with celiac disease will be randomized to HIIT+ or waitlist control (WLC). Participants in the HIIT+ will engage in a 12-week HIIT?+?lifestyle education program. HIIT sessions will be comprised of 2 workouts per week, working up to 14?×?30-second intervals at 90% maximal heart rate (HRmax) followed by 2 minutes recovery at 50% HRmax. The 6 biweekly lifestyle sessions will involve education on the promotion of a whole foods GFD, sleep hygiene, psychosocial coping skills (eg, self-compassion), and self-regulatory skills to master changes in behaviors. Assessments will occur at pre and post 12-week intervention and 3-month follow-up. WLC participants will be offered a 12-week HIIT program?+?online lifestyle education sessions after completing the final assessment. The primary outcomes are QoL and gut microbiota composition assessed with 16S rRNA sequencing. The secondary outcomes are markers of metabolic syndrome (waist circumference, fasting glucose, serum lipids, blood pressure, and body composition), gastrointestinal symptoms, sleep quality, adherence to a GFD, exercise behavior, self-regulatory efficacy, and self-compassion. It is hypothesized that participants in the HIIT+ will experience improvements in all outcomes when compared to those in the WLC. These improvements are expected to be maintained at the 3-month follow-up. Discussion:The findings from this study will advance the knowledge regarding the effects of HIIT and lifestyle education on key outcomes for an at-risk chronic disease population. Furthermore, the findings can be used to inform future programs to improve fitness and physical and mental health outcomes for people with celiac disease.

SUBMITTER: Dowd AJ

PROVIDER: S-EPMC6563390 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A 12-Week Pilot Exercise Program for Inactive Adults With Celiac Disease: Study Protocol.

Dowd A Justine AJ Kronlund Liam L Parmar Candice C Daun Julia T JT Wytsma-Fisher Kathryn K Reimer Raylene A RA Millet Guillaume Y GY Culos-Reed S Nicole SN

Global advances in health and medicine 20190611

<h4>Background</h4>Individuals with celiac disease must follow a strict gluten-free diet (GFD) in order to avoid negative short- and long-term health consequences. Unfortunately, many people with celiac disease report poor quality of life (QoL) despite following a strict GFD, and up to 30% still report negative symptoms (eg, gastrointestinal upset).<h4>Purpose</h4>The purpose of the MOVE-C (understanding the relationship between the <i>M</i>icrobi<i>O</i>me, <i>V</i>itality, and <i>E</i>xercise ...[more]

PMID: 31218116

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Project description:BackgroundSystemic lupus erythematosus is a systemic autoimmune disease, which is associated with high cardiovascular risk, a predisposition to metabolic disorders, muscle wasting, and fatigue. Exercise therapy has become an important part of the long-term treatment of comorbidities in systemic lupus erythematosus. Exercise can lead to various benefits in patients with systemic lupus erythematosus such as increased aerobic capacity and exercise tolerance, resulting in an increased quality of life, decreased depression, and decreased fatigue. At the moment, no evidence-based treatment guidelines that recommend exercise for patients with systemic lupus erythematosus exist. Also, the efficacy of different training programs requires further investigation.ObjectiveThis study focuses on the feasibility, efficacy, and safety of an internet-based exercise program in patients with systemic lupus erythematosus. Furthermore, we investigate the feasibility and efficiency of anaerobic training compared to aerobic training.MethodsOverall, patients with systemic lupus erythematosus from the Division of Nephrology, Rheumatology, and Immunology outpatient clinic of the University Medical Center Mainz who are clinically stable status are included and randomized in an aerobic exercise group (n=10), anaerobic exercise group (n=10), or treatment as usual group (n=10). After completing initial clinical testing and physical fitness tests, patients undergo supervised 12-week online exercise programs, receiving weekly individualized training plans adapted to their physical performance. The primary outcome is change in physical fitness (VO2 peak) after 12 weeks compared to baseline. Secondary outcomes are disease activity measured via laboratory results (complement, autoantibodies) and questionnaires, as well as changes in muscle mass (anaerobic exercise group), results of the Chair-Stand test, and measurements of circulating cell-free DNA and extracellular vesicles.ResultsThe study was registered in May 2019. Enrollment began in May 2019. Of 40 patients who were initially screened, 30 patients fulfilled the inclusion criteria and were included in the study; 1 participant withdrew prior to the start of the exercise program. Among the 25 patients who completed the study, no serious adverse events have been reported; 3 participants withdrew during the program (due to frequent colds, n=1; Crohn relapse, n=1; physical strain, n=1), and 1 participant has not yet completed the program. Data analysis is ongoing, and results are expected to be submitted for publication in January 2021.ConclusionsWe expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus.Trial registrationClinicalTrials.gov NCT03942718; http://clinicaltrials.gov/ct2/show/NCT03942718.International registered report identifier (irrid)DERR1-10.2196/18291.

Project description:BackgroundPhysical literacy (PL), given as a multidimensional construct, is considered a person's capacity and commitment to a physically active lifestyle. We investigated the effect of a holistic physical exercise training on PL among physically inactive adults.MethodsA non-randomised controlled study was conducted. Thirty-one physically inactive adults in the intervention group (IG; 81% females, 44?±?16?years) participated in a holistic physical exercise training intervention once weekly for 15?weeks. A matched, non-exercising control group (CG) consisted of 30 physically inactive adults (80% female, 45?±?11?years). PL, compliance and sociodemographic parameters were measured. PL was evaluated by a questionnaire, covering five domains: physical activity behaviour, attitude towards a physically active lifestyle, exercise motivation, knowledge and self-confidence/self-efficacy. Data were analysed using ANCOVA models, adjusted for age, gender and BMI at baseline.ResultsAt post-training intervention, the IG showed significant improvements in PL (p?=?0.001) and in the domains physical activity behaviour (p?=?0.02) and exercise self-confidence/self-efficacy (p?=?0.001), with no changes overserved for the CG regarding PL and those domains. No intervention effect were found for the other three domains, i.e. attitude, knowledge and motivation. Additionally, for the IG baseline BMI was identified to be positively correlated with physical exercise-induced improvements in PL (??=?0.51, p?=?0.01).ConclusionsThe results from this study are very useful for further public health activities, which aim at helping physically inactive adults to adopt a physically active lifestyle as well as for the development of further PL intervention strategies. This pilot-study was a first attempt to measure PL in inactive adults. Yet, a validated measurement tool is still not available. Further research is necessary to determine the psychometric properties for this PL questionnaire.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00013991 , date of registration: 09.02.2018, retrospectively registered.

Project description:BackgroundMild cognitive impairment (MCI) is a syndrome characterised by a decline in cognition but relatively intact activities of daily living. People with MCI have an increased risk of developing dementia, and MCI is often referred to as a transitional stage between healthy ageing and dementia. Currently, there are no pharmaceutical therapies approved by the US Federal Drug Administration for MCI. Randomised controlled trials on the two major classes of anti-dementia pharmaceuticals, cholinesterase inhibitors and glutamate receptor antagonists, have produced poor results in MCI cohorts. There is a need to test and evaluate new and promising treatments for MCI that target multiple aspects of the syndrome's multi-faceted pathophysiology. The primary aim of this study is to evaluate the efficacy of 12 weeks of treatment with a standardised herbal formula, Sailuotong (SLT), compared to placebo, on cognition in older adults with MCI. Secondary aims are to assess SLT's mechanisms of action via electroencephalography (EEG), autonomic function, brain blood flow, and inflammation, as well as its safety in this cohort.Methods/designThe target cohort for this trial is community-dwelling older adults over the age of 60 years who meet the National Institute of Aging-Alzheimer's Association working group core clinical criteria for MCI due to Alzheimer's disease. Eighty participants will be recruited and randomly allocated via a permuted block strategy at a 1:1 ratio to either the treatment or placebo group. The co-primary cognitive outcome measures are Logical Memory Story A delayed recall (episodic memory), Letter Number Sequencing (perceptual processing speed), and both the Trail Making Test and Rey Complex Figure Test (executive function). Secondary outcome measures are EEG activity, autonomic function (via electrocardiogram, skin conductance, and peripheral pulse pressure), brain blood flow (via common carotid artery ultrasound), and serum concentrations of inflammatory cytokines. Analyses will be performed blind to group allocation.DiscussionThis study is a 12-week, randomised, double-blind, placebo-controlled trial. Primary and secondary outcome measures will be compared between treatment and placebo groups at baseline and endpoint. Data from this pilot study will inform a larger, more highly powered clinical trial if the findings are positive.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000371392 Registered on 10 March 2017.

Project description:There is evidence to suggest that postprandial lipemia are is linked to the impairment of endothelial function, which is characterized by an imbalance between the actions of vasodilators and vasoconstrictors. The aim of this study was to determine the effects of a 12-week high-intensity training (HIT) and moderate continuous training (MCT) protocol on postprandial lipemia, vascular function and arterial stiffness in inactive adults after high-fat meal (HFM) ingestion.A randomized clinical trial was conducted in 20 healthy, inactive adults (31.6?±?7.1 years). Participants followed the two exercise protocols for 12 weeks. To induce a state of postprandial lipemia (PPL), all subjects received a HFM. Endothelial function was measured using flow-mediated vasodilation (FMD), normalized brachial artery FMD (nFMD), aortic pulse wave velocity (PWV) and augmentation index (AIx). Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-c), triglycerides and glucose were also measured.The effects of a HFM were evaluated in a fasted state and 60, 120, 180, and 240 min postprandially. A significant decrease in serum glucose between 0 min (fasted state) and 120 min postprandially was found in the HIT group (P?=?0.035). Likewise, FMD (%) was significantly different between the fasted state and 60 min after a HFM in the HIT group (P?=?0.042). The total cholesterol response expressed as area under curve (AUC)(0-240) was lower following HIT than following MCT, but no significant differences were observed (8%, P?>?0.05). Similarly, triglycerides AUC(0-240) was also lower after HIT compared with MCT, which trended towards significance (24%, P?=?0.076). The AUC(0-240) for the glucose response was significantly lower following HIT than MCT (10%, P?=?0.008). FMD and nFMD AUC(0-240) were significantly higher following HIT than following MCT (46.9%, P?=?0.021 and 67.3%, P?=?0.009, respectively). PWV AUC(0-240) did not differ following between the two exercise groups (2.3%, P?>?0.05).Supervised exercise training mitigates endothelial dysfunction and glucose response induced by PPL. Exercise intensity plays an important role in these protective effects, and medium-term HIT may be more effective than MCT in reducing postprandial glucose levels and attenuating vascular impairment.ClinicalTrials.gov ID: NCT02738385 Date of registration: April 14, 2016.

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A 12-Week Pilot Exercise Program for Inactive Adults With Celiac Disease: Study Protocol.

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A 12-Week Pilot Exercise Program for Inactive Adults With Celiac Disease: Study Protocol.

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