Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage HD



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:11/21/2018
Start Date:October 10, 2017
End Date:June 1, 2019

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Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage Huntington's Disease

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.

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.

Inclusion Criteria:

- For premanifest - Confirmatory genetic testing for Huntington disease (HD) and
diagnostic confidence score of 0-3 on Unified Huntington Disease Rating Scale,
indicating pre-manifest disease state. For manifest HD - Confirmatory genetic testing
for HD or confirmed clinical diagnosis of HD by neurologist

- Successful completion of Physical Activity Readiness Questionnaire (PAR-Q), or medical
clearance from General Practioner

- For potential participants over age 60, a minimum score of 24 on the Mini-Mental State
Examination (MMSE) (completed within 3 months) will be required for capacity to
consent.

- For potential participants age 60-65, successful pass of electrocardiogram screen will
be required.

Exclusion Criteria:

- Musculoskeletal injury that would interfere with participation in an exercise program

- Currently participating in a structured exercise program 3 times per week or more

- Uncontrolled psychiatric or behavioral problems that would interfere with
participation in an exercise program
We found this trial at
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New York, New York 10027
(212) 854-1754
Phone: 212-678-3916
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