Huntington's Disease Clinical Trial
Official title:
Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage Huntington's Disease
Verified date | November 2018 |
Source | Teachers College, Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | April 1, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Teachers College, Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in physical activity (daily step counts) at 4 months | Physical activity as measured by waist worn device (Actigraph) | 4 months | |
Secondary | Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months | Questionnaire evaluating level of physical activity over past 7 days | 4 months | |
Secondary | Change in Lorig self efficacy scale at 4 months | Self efficacy questionnaire | 4 months | |
Secondary | Change in 6 minute walk distance at 4 months | Endurance measured by 6 minute walk test - distance completed over 6 minutes of walking | 4 months | |
Secondary | Change in grip strength at 4 months | Hand strength as measured with hand held dynamometer | 4 months | |
Secondary | Change in HD-PRO-TRIAD at 4 months | Questionnaire evaluating disease-specific measure of HD symptoms (cognitive, emotional and motor function) | 4 months | |
Secondary | Change in Unified Huntington Disease rating scale Total Motor Score at 4 months | Disease-specific measure of motor function | 4 months | |
Secondary | Change in Behavioral Regulation in Exercise Questionnaire (BREQ 2) at 4 months | A 19 item questionnaire measuring stages of self determination continuum | 4 months | |
Secondary | Change in Unified Huntington Disease Rating Scale Cognitive battery at 4 months | Disease-specific cognitive function as measured by Unified Huntington Disease Cognitive battery (Stroop, Symbol digit modality and verbal fluency) | 4 months |
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