Energy Balance in Huntington's Disease. A Multidisciplinary Study Approach for a Complex Problem (BEHD-EM)

NCT05250323 | Completed

• 1 other identifier: CEIM-2429
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted at the University Isabel I, Burgos in collaboration with the Hospital Universitario Burgos, Spain, through the creation of a multidisciplinary research team including graduates in physical activity and sports sciences, dietitians-nutritionists, neurologists and occupational therapists. To carry out this study: 1) the investigators used new technologies, specifically, small wearable or wearable devices available to the population. These devices measure their daily behaviour and estimate aspects such as energy expenditure, validated both in healthy participants and in participants with neurodegenerative diseases such as Parkinson's disease, but not in HD; 2) the investigators included a consecutive sample of patients with HD ; 3) the investigators performed the experimental study at the the laboratory for Exercise Physiology, Health and Quality of Life at the Isabel I University. The hypothesis proposed by this study are the following: 1) Patients with HD who present an adequate energy balance caused by healthier lifestyles (active lifestyles and healthy eating) will present a better functional capacity, quality of life and therefore both less dependency; 2) HD patients with a balanced energy balance maintain adequate body composition (muscle, fat); 3) Adequate body composition is associated with better functional capacity in HD patients.

Conditions

Huntington Disease

Keywords

energy expenditure; physical activity; nutrition; wereables; daily life activity

Outcome Measures

Primary Outcomes (4)

• Measurement of energy expenditure at rest

  by indirect calorimetry recording respiratory exchange (Medisoft Ergocard, Medisoft Group, Sorinnes, Belgium)

  10 minutes

• Measurement of energy expenditure due to physical activity

  using a wearable device (Fitbit Charge), which allows quantification in a valid and reliable way, in patients with HD

  45 minutes

• Determination of caloric intake

  by registering eating habits (SUN food frequency questionnaire and a 3-day food diary)

  30 minutes

• Bone densitometry (DXA)

  Determination of body composition

  10 minutes

Secondary Outcomes (3)

• Validation of the wearable comparing the results with a gold standard

  45 minutes

• Determination of the incidence of thermogenesis on energy expenditure and on the appearance of fatigue

  2 hours

• Determination of lifestyle and weekly energy expenditure

  7 days

Study Arms (2)

Case

Patients with genetic confirmation of Huntington's disease, symptomatic (motor manifestations with a score greater than 4 on the Unified HD scale), who can walk with minimal support, without sensory deficits or other systemic diseases an Investigator judgment that may interfere with the execution of the study, coming from the Enroll study.

Other: observational tests in face-to-face visit

Control

Age, gender-matched non-gene carriers family relatives

Other: observational tests in face-to-face visit

Interventions

observational tests in face-to-face visit OTHER

All necessary evaluations will be carried out for data collection. Also, that same day, the investigators will give the device to participants for the 7-day home assessment

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with Huntington's disease and non-gene family relatives

You may qualify if:

• Older than 18 years-old
• Genetic confirmation of Huntington's disease
• Symptomatic (motor manifestations with a score greater than 4 on the Unified HD scale)
• Walk with minimal support
• Participate in Enroll study
• Non-gene carriers, family relatives

You may not qualify if:

• Sensory deficits or other systemic diseases which according to the Investigator judgment may interfere with the execution of the study

Sponsors & Collaborators

• Hospital Universitario de Burgos: lead
• La Caixa Foundation: collaborator
• Universidad Isabel I: collaborator

Study Sites (1)

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

MeSH Terms

Conditions

Huntington Disease; Motor Activity

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Neurology

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 22, 2022
• Study Start: May 14, 2021
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)