None listed
Conditions
Brief summary
Study Aims This study aims to assess feasibility, therapeutic utility and cost effectiveness of multidisciplinary therapy coaching compared to lifestyle guidance for individuals with premanifest and manifest Huntington's disease. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older and been diagnosed with premanifest or early stage manifest Huntington's disease. Study details Participants will be randomly assigned (by chance) to receive either multidisciplinary therapy coaching or lifestyle guidance. Those in the multidisciplinary therapy coaching will receive personalized exercise, cognitive and sleep hygiene coaching for twelve months. Those in the lifestyle guidance group will receive a booklet containing information on gold standard recommendations on exercise, cognitive and sleep hygiene. All participants will undergo a series of diagnostic and clinical tests, including cognitive, mood, sleep, activities of daily living tests and questionnaires. Potential study outcomes It is hoped this research will inform the treatment of individuals with premanifest and manifest HD.
Interventions
This is a single-blind (assessor blinded to group allocation), two arm (multidisciplinary therapy coaching program versus lifestyle guidance), randomised controlled trial. This trial will examine the feasibility, safety and therapeutic effects of a multidisciplinary therapy coaching program, compared to lifestyle guidance, for individuals with premanifest and manifest Huntington's disease. Participants will be randomly assigned to receive the multidisciplinary therapy coaching program or lifestyle guidance by an independent statistician. Participants in both groups will receive 12 months of treatment (multidisciplinary therapy coaching program/lifestyle guidance). Multidisciplinary Therapy Coaching Program The multidisciplinary therapy coaching intervention will be designed by an interdisciplinary team of specialists comprising exercise physiologists, neuroscientists, occupational therapists and physiotherapists. The intervention will encompass cardiorespiratory and resistance exercise training, cognitive training and sleep hygiene two exercise training sessions per week and two computerised cognitive training sessions per week at home. Participants will also be asked to maintain good sleep hygiene throughout the study as indicated by the sleep resources provided. To maximise participant adherence and clinical benefits the multidisciplinary therapy coaching program will be structured into distinct cycles comprising of active, tapering and rest weeks. Six cycles, each eight weeks in duration, will be delivered during the intervention period. The intervention will be delivered by trained multidisciplinary therapy coaches (exercise physiologists). Participants will be contacted by a coach on two separate occasions, at the beginning and midway point (4 weeks) of each cycle. The implementation and progress of the program for that cycle as well as the barriers to training and goals for the upcoming cycle will be discussed. Cardiorespiratory (e.g., swimming, walking, running) and Resistance Exercise Training (e.g., chest press, upright rows) The exercise training component of the intervention will comprise individualised (i.e., adjusted to cardiorespiratory fitness [percentage of predicted heart rate max: 220-participant age]), block periodised (i.e., systematically organised exercise variation [volume, intensity and use of specific exercises] into mesocycles [eight week blocks]), progressive and autoregulated (i.e., the volume and intensity of training will be adjusted based on the training response and well-being of patients on training days [i.e., muscle soreness and motivation]) aerobic and resistance exercise training. The intervention will comprise six training blocks that are eight weeks in duration. Each training block will comprise of a training phase (weeks 1-6), detraining/deloading phase (week 7) and rest phase (week 8). An additional rest phase (1 week) will be provided every 16 weeks. Participants will be asked to complete two 45 minute exercise training sessions per week. The intervention will be delivered in the home environment via telehealth applications (Microsoft Teams). The intensity of exercise during training sessions will be prescribed by percentage of predicted heart rate max (cardiorespiratory) and repetitions in reserve (resistance). The exercise program will be monitored by exercise physiologists and an occupational therapist to ensure that participants reach their target rate of perceived exertion (RPE). Cognitive Training The cognitive training program will consist of computerised cognitive training. Computerised cognitive training will be undertaken using NeuroNation software. The prescription and dose of computerised cognitive training are informed by previous work and target a number of cognitive domains including working memory, executive control, divided attention and response inhibition, which are compromised early in HD. Training performance will be automatically recorded by the computerised cognitive training software. Cognitive training will be undertaken twice weekly for 45 minutes. Sleep Hygiene: The sleep hygiene intervention will comprise expert recommendations on healthy sleep habits (Morton et al 2013). Participants will also be provided with and encouraged to follow sleep hygiene guidelines as formulated in the Principles and Practice of Sleep Medicine. Participants will receive tailored advice from their coach for thirty minutes (via telehealth) at the start of each block on how to integrate sleep hygiene practices into their sleep routine. Adherence will be evaluated via an intervention diary. Participants will be asked to tick each sleep health recommendation that they adhered to on a weekly basis.
Sponsors
Study design
Eligibility
Inclusion criteria
Forty-two individuals with premanifest HD (CAG > 39, DBS > 250, UHDRS-TMS < 5) and 42 individuals with early manifest HD (CAG > 39, UHDRS-TMS > 5, TFC > 7) will be recruited for this trial (effect size: f = .25, a = .05 and power (1- ß) = 80%). Participants will be required to provide written and informed consent prior to undertaking any study procedures.
Exclusion criteria
Exclusion criteria for participants will include concomitant cardiovascular, metabolic, immunological, neurological and musculoskeletal conditions as well as recent or ongoing substance abuse.