Columbia University
New York, 10027, United States
NCT Number: NCT03306888
This study will evaluate the feasibility and acceptability of a clinic-based physical activity coaching intervention in people with pre-manifest and early stage Huntington's Disease (HD). Fourteen individuals with premanifest and early stage HD will be recruited to participate in a 4 month coaching intervention. Feasibility will be assessed by recruitment and retention rates, and acceptability will be assessed by participant interviews. Participants will also be evaluate at baseline and following the coaching intervention to explore preliminary efficacy in terms of physical activity, self efficacy, disease-specific motor and cognitive function, walking endurance and strength.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
New York, 10027, United States
The investigators have previously developed and evaluated a physical activity behavioral change intervention in people with early-mid stage HD (Engage-HD). In a study conducted in the United Kingdom, self-reported physical activity, self-efficacy for exercise, and cognition were increased for those in the coaching intervention group compared to a social contact control group. This intervention has not yet been applied to individuals with pre-manifest (prior to onset of clinical symptoms) and early stage HD, where it may be most critical to engage in exercise. To date, no study has prospectively evaluated a physical activity intervention to facilitate exercise uptake in these earliest stages. This study will explore the feasibility and acceptability of the Engage-HD intervention in 14 individuals with pre-manifest and early stage HD. The intervention will entail one face-to-face coaching session (approximately 1 hour), and three remote video sessions (via secure Webex connection via computer or smart phone, or phone call if internet/smart phone is not available to participant) lasting approximately 20 minutes. Participants will also be given FitBit wearable activity monitors to allow for self- monitoring of physical activity for use during the 4-month intervention. Participants will be evaluated at baseline and again 4 months later on a range of exploratory outcomes including physical activity, self efficacy, disease-specific motor and cognitive function, walking endurance and strength. Results from this study will be used to make relevant adaptations to prepare for a multi-site randomized controlled trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physical activity coaching over 4 months
Time frame: 4 months
Physical activity as measured by waist worn device (Actigraph)
Time frame: 4 months
Questionnaire evaluating level of physical activity over past 7 days
Time frame: 4 months
Self efficacy questionnaire
Time frame: 4 months
Endurance measured by 6 minute walk test - distance completed over 6 minutes of walking
Time frame: 4 months
Hand strength as measured with hand held dynamometer
Time frame: 4 months
Questionnaire evaluating disease-specific measure of HD symptoms (cognitive, emotional and motor function)
Time frame: 4 months
Disease-specific measure of motor function
Time frame: 4 months
A 19 item questionnaire measuring stages of self determination continuum
Time frame: 4 months
Disease-specific cognitive function as measured by Unified Huntington Disease Cognitive battery (Stroop, Symbol digit modality and verbal fluency)
Teachers College, Columbia University
Other
Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage Huntington's Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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