Previously submitted to: JMIR Research Protocols (no longer under consideration since Sep 19, 2023)
Date Submitted: Aug 8, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Protocol of Energy balance estimates in Huntington's disease. An observational, case-control, multicenter pilot study.
ABSTRACT
Background:
Among the different clinical manifestations, weight loss and energy balance (EB) deficit have been described frequently in Huntington's disease (HD), contributing to HD progression. To develop a therapeutic approach to prevent weight loss and EB deficit in HD, we will conduct a study designed to validate the usefulness of accelerometers to estimate energy expenditure, bioelectrical impedance analysis (BIA) to estimate body composition in HD patients, and the impact of EB on HD severity, sarcopenia status, patient's health-related quality of life (QoL), and caregiver burden. The present paper presents the protocol for an energy balance study in HD patients vs. controls.
Objective:
To determine the accuracy of accelerometers and BIA, to estimate energy expenditure related to physical activity and body composition, respectively. Secondly, to estimate and compare EB in HD vs. healthy controls and the impact of EB on HD severity, quality of life, and caregiver burden.
Methods:
Design: Ongoing, cross-sectional, multicenter, case-control, observational study. We will include 20 patients diagnosed with HD, and 10 healthy-matched controls. HD severity, quality of life, and caregiver burden will be assessed using validated rating scales. EB will be calculated as energy intake minus total energy expenditure (TEE). Validation of accelerometers vs. indirect calorimetry, and BIA vs. Dual-energy X-ray absorptiometry, will be performed using the intra-class correlation coefficient (ICC) and Bland-Altman plots. We will perform multivariate linear regression analysis, including EB as the dependent variable and sociodemographics, HD severity, and quality of life as the independent variables.
Results:
This study will provide valuable data to facilitate the use of accelerometers and BIA in HD, and preliminary data on the impact of EB on HD severity, quality of life, and caregiver burden.
Conclusions:
In this challenging initiative, determining the accuracy of accelerometers, we will facilitate the assessment of energy expenditure in a free-living setting and the use of BIA in HD. Overall, we will provide the scientific rationality to understand EB deficit to prevent malnutrition and other comorbidities. Clinical Trial: ClinicalTrials.gov Identifier: NCT05250323
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