An observational study providing new insights into lifestyle and genetic risk factors in Huntington’s disease

Multi DOMain lifestyle targets for Improving progNOsis in Huntington's Disease (DOMINO-HD)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12103732

Enrollment

300

Registered

2020-08-20

Start date

2020-11-01

Completion date

Unknown

Last updated

2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington's Disease (HD) Nervous System Diseases Huntington Disease

Interventions

DOMINO will be conducted in two phases. Individual consortium partners will be responsible for performing phase 1 sub-studies within their site and /or in collaboration with other partners. The phase

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Huntington's Disease (HD) confirmed by genetic testing 2. Aged =18 years 3. Diagnostic confidence level (DCL) 3 and 4 (which can include both pre-motor [late prodromal] or motor manifest HD) 4. Self-ambulatory 5. Participating (current or newly enrolled) in the Enroll-HD study (with a preference for those who have been genotyped in GWAS3-5 or are to be genotyped in GWAS6)

Exclusion criteria

Exclusion criteria: 1. Diagnosis of juvenile onset Huntington's Disease (HD) 2. History of co-morbid neurological conditions such as multiple sclerosis or stroke 3. Acute (within 1 month) orthopaedic conditions such as an ankle sprain or fracture 4. Severe medical conditions such as unstable or progressive heart disease, uncontrolled diabetes, severe liver, kidney or thyroid dysfunction, or similar medical conditions 5. Any acute or unstable psychiatric condition 6. Unable to tolerate long-term wear of activity monitor 7. Inability or unwillingness to give written informed consent 8. No access to a smartphone 9. Not willing to allow the research team to install Apps on their smartphone related to the study

Design outcomes

Primary

Measure	Time frame
Feasibility of linking lifestyle factors and genetic risk factors to explore their interplay with HD symptom severity assessed through the linking of: physical activity data (from Fitbit charge 4) measured continuously from baseline for 12 months; and genotyping and clinical assessment data (in motor, cognitive and behavioural domains to include measures of symptom severity, collected via Enroll-HD) at baseline and 12 months.	—

Measure

Time frame

Feasibility of linking lifestyle factors and genetic risk factors to explore their interplay with HD symptom severity assessed through the linking of: physical activity data (from Fitbit charge 4) measured continuously from baseline for 12 months; and genotyping and clinical assessment data (in motor, cognitive and behavioural domains to include measures of symptom severity, collected via Enroll-HD) at baseline and 12 months.

—

Secondary

Measure	Time frame
1. Feasibility and acceptability of using digital technologies to consistently collect information directly from people with HD about their physical activity, sleep, and diet using a combination of questionnaires and semi structured interviews. These will be completed at baseline, 12 months and after 7 day in home assessments. 2. Appropriateness of commercially available activity trackers to measure physical activity and sleep in people with HD using data obtained from activity trackers and other specific activity and sleep recording devices in combination with video analysis and participant self-report diaries during phase 1 study assessments. Sub study 1: 1. Accuracy of physical activity and heart rate metrics provided by the Fitbit Charge 4 compared to ground truth information on number of steps performed whilst in the motion analysis lab setting using summary metrics obtained from the activity trackers and compared to movement analysis from video recordings and participant self-reported diaries obtained during the visit to the motion lab or during the 7-day in-home assessment 2. Influence of device location on the quantification of physical activity metrics in people with HD using summary metrics obtained from the activity trackers and compared to movement analysis from video recordings and participant self-reported diaries obtained during the visit to the motion lab or during the 7-day in-home assessment 3. Difference in physical activity metrics obtained from different devices worn on the wrist and thigh using summary metrics obtained from the activity trackers and compared to movement analysis from video recordings and participant self-reported diaries obtained during the visit to the motion lab or during the 7-day in-home assessment 4. Movement signatures of people with HD performing physical activities/during sleep measured during the visit to the motion lab or during the 7-day in-home assessment, in order to inform the development of HD specific activ	—

Measure

Time frame

1. Feasibility and acceptability of using digital technologies to consistently collect information directly from people with HD about their physical activity, sleep, and diet using a combination of questionnaires and semi structured interviews. These will be completed at baseline, 12 months and after 7 day in home assessments. 2. Appropriateness of commercially available activity trackers to measure physical activity and sleep in people with HD using data obtained from activity trackers and other specific activity and sleep recording devices in combination with video analysis and participant self-report diaries during phase 1 study assessments. Sub study 1: 1. Accuracy of physical activity and heart rate metrics provided by the Fitbit Charge 4 compared to ground truth information on number of steps performed whilst in the motion analysis lab setting using summary metrics obtained from the activity trackers and compared to movement analysis from video recordings and participant self-reported diaries obtained during the visit to the motion lab or during the 7-day in-home assessment 2. Influence of device location on the quantification of physical activity metrics in people with HD using summary metrics obtained from the activity trackers and compared to movement analysis from video recordings and participant self-reported diaries obtained during the visit to the motion lab or during the 7-day in-home assessment 3. Difference in physical activity metrics obtained from different devices worn on the wrist and thigh using summary metrics obtained from the activity trackers and compared to movement analysis from video recordings and participant self-reported diaries obtained during the visit to the motion lab or during the 7-day in-home assessment 4. Movement signatures of people with HD performing physical activities/during sleep measured during the visit to the motion lab or during the 7-day in-home assessment, in order to inform the development of HD specific activ

—

Countries

Germany, Poland, Spain, Switzerland, United Kingdom, Wales

Contacts

Public ContactCheney Drew

DrewC5@cardiff.ac.uk+44 (0)2920687243

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026