title: Supporting physical activity engagement in people with Huntington's disease (ENGAGE-HD): study protocol for a randomized controlled feasibility trial.
abstract: BACKGROUND
  Huntington's disease (HD) is a complex, single-gene inherited neurodegenerative condition resulting in symptoms that occur across a wide range of neurological domains, including cognitive, behavioral and motor. The benefits of regular physical activity for people with HD are widely recognized. However, a number of factors can prohibit sustained exercise and activity. The purpose of this trial is to explore the feasibility, acceptability and effectiveness of a physical activity intervention program targeted for people with early- to mid-stage HD.
  
  
  METHODS
  The proposed trial is a single blind, multisite, exploratory, randomized controlled feasibility trial of a physical activity intervention. A total of 62 participants with genetically confirmed HD will be recruited. Each participant will be involved in the trial for 26 weeks. Participants will be randomized immediately following the baseline assessment into either a physical activity intervention or a social contact control intervention. The physical activity intervention is framed around self-determination theory placed within a broader behaviour change wheel framework. An HD-specific workbook and individual goal setting will be utilized over six 1:1 sessions, with interim telephone calls. All participants will be reassessed at 16 weeks following the baseline assessment, and then again at a final follow-up assessment 26 weeks later. At the end of the study, all participants will be offered a brief version of the alternative intervention, with one home visit and one follow-up telephone call.
  
  
  CONCLUSIONS
  Engaging and supporting people with HD in a regular physical activity program raises a number of challenges. The physical activity intervention and the comparator social interaction intervention have been developed following consultation with people with HD and their families. Each are individually tailored and determined on individual needs and goals. The results from this trial will provide guidance for the development of definitive trials.
  
  
  BACKGROUND
  The trial was registered with ISRCTN ( http://www.isrctn.com/ISRCTN65378754) on 13 March 2014.
authors.affiliation: School of Healthcare Sciences, Ty Dewi Sant, Heath Park Campus, Cardiff University, Cardiff CF14 4XN, UK. busseme@cardiff.ac.uk.
authors.forename: Monica
authors.initials: M
authors.lastname: Busse
authors.forename: Lori
authors.initials: L
authors.lastname: Quinn
authors.forename: Helen
authors.initials: H
authors.lastname: Dawes
authors.forename: Carys
authors.initials: C
authors.lastname: Jones
authors.forename: Mark
authors.initials: M
authors.lastname: Kelson
authors.forename: Vincent
authors.initials: V
authors.lastname: Poile
authors.forename: Rob
authors.initials: R
authors.lastname: Trubey
authors.forename: Julia
authors.initials: J
authors.lastname: Townson
authors.forename: Rhiannon Tudor
authors.initials: RT
authors.lastname: Edwards
authors.forename: Anne
authors.initials: A
authors.lastname: Rosser
authors.forename: Kerenza
authors.initials: K
authors.lastname: Hood
mesh_terms: D002985:Clinical Protocols; D005060:Europe; D005081:Exercise Therapy / Q000379:methods*; D005240:Feasibility Studies; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D006816:Huntington Disease / Q000175:diagnosis / Q000235:genetics / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D007398:Interpersonal Relations; D009042:Motivation; D009043:Motor Activity; D026684:Personal Autonomy; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome