Topic: Dementias and Neurodegenerative Diseases Research Network
Conditions
Interventions
ENGAGE-HD: Participants enrolled in the ENGAGE-HD Physical Activity Intervention will receive 6 home visits and interim phone calls over a course of 16 weeks (weeks 1, 2, 3, 6, 10 and 14). They will
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/10/2014: 1. Diagnosis of manifest HD, confirmed by genetic testing 2. Self-reported or physician-reported difficulties with walking and/or balance (but still able to walk with minimal assistance) 3. Above the age of 18 4. Stable medication regime for 4 weeks prior to initiation of trial, and anticipated to be able to maintain a stable regime for the course of trial 5. Enrolled on EHDN Registry/ENROLL-HD study [or if not enrolled, that the clinician is able to provide a recent specialist HD clinical assessment that includes a UHDRS TMS score, full medical history and a record of the CAG length (longer allele)] Previous inclusion criteria: 1. Diagnosis of manifest HD, confirmed by genetic testing 2. Self-reported or physician-reported difficulties with walking and/or balance (but still able to walk with minimal assistance) 3. Above the age of 18 4. Stable medication regime for 4 weeks prior to initiation of trial, and anticipated to be able to maintain a stable regime for the course of trial 5. Enrolled on EHDN Registry/ENROLL-HD study
Exclusion criteria
Exclusion criteria: 1. Any physical or psychiatric condition that would prohibit the participant from completing the intervention or the full battery of assessments 2. Unable to understand or communicate in spoken English 3. Currently involved in any interventional trial or within 4 weeks of completing an interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 09/12/2014: The primary feasibility outcome will include an evaluation of eligibility, recruitment and retention rates (in line with CONSORT recommendations) as well as monitoring of completion of outcome measures and assessments. Previous primary outcome measures: Physical Performance Test; Timepoint(s): baseline, 16 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 09/12/2014: A range of secondary measures will be explored in terms of short-term benefit (timepoints: baseline, 16 weeks and 24 weeks). The main assessment of short-term benefit will be provided by the Physical Performance Test (PPT) Added 13/03/2017: Measures of participation and health: 1. Individualised quality of life, measured using the schedule for the evaluation of individual quality of life—direct weighting (SEIQoL-DW) at follow up assessment (week +26) 2. Self-efficacy, measured using the Lorig self-efficacy scale at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 3. Health service use, measured using the Client Services Receipt Inventory at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 4. Health utility, measured using EQ-5D-5L and ICE-CAP-A at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) Measures of activity: 1. Functional activity, measured using the Physical Performance Test (PPT) at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 2. Usual pattern of mobility, measured using the Life Space Assessment at baseline (week 0), follow up assessment (week +26) 3. Physical activity, measured using the International Physical Activity Questionnaire (Short Form) at baseline (week 0), follow up assessment (week +26) 4. Walking ability, measured using the six minute walk test and the Timed Up and Go Test at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 5. Self-reported falls, including the frequency, circumstance and severity of any falls at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) Measures of body function: 1. Disease-specific clinical measure of motor impairment, measured using the Unified Huntington Disease Rating Scale (UHDRS) modified motor scale at baseline (week 0), primary outcome asses | — |
Countries
United Kingdom
Outcome results
None listed