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

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ClinicalTrials.gov Identifier: NCT03306888
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Teachers College, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Huntington's Disease Other: Physical Activity Coaching Phase 1 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm feasibility study with 14 participants
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage Huntington's Disease
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : June 1, 2019


Arm Intervention/treatment
Experimental: Physical Activity Coaching Intervention
The intervention will entail one face-to-face coaching session (approximately 1 hour) to be held approximately 1 week following the baseline assessment, 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.
Other: Physical Activity Coaching
Physical activity coaching over 4 months




Primary Outcome Measures :
  1. Change in physical activity (daily step counts) at 4 months [ Time Frame: 4 months ]
    Physical activity as measured by waist worn device (Actigraph)


Secondary Outcome Measures :
  1. Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months [ Time Frame: 4 months ]
    Questionnaire evaluating level of physical activity over past 7 days

  2. Change in Lorig self efficacy scale at 4 months [ Time Frame: 4 months ]
    Self efficacy questionnaire

  3. Change in 6 minute walk distance at 4 months [ Time Frame: 4 months ]
    Endurance measured by 6 minute walk test - distance completed over 6 minutes of walking

  4. Change in grip strength at 4 months [ Time Frame: 4 months ]
    Hand strength as measured with hand held dynamometer

  5. Change in HD-PRO-TRIAD at 4 months [ Time Frame: 4 months ]
    Questionnaire evaluating disease-specific measure of HD symptoms (cognitive, emotional and motor function)

  6. Change in Unified Huntington Disease rating scale Total Motor Score at 4 months [ Time Frame: 4 months ]
    Disease-specific measure of motor function

  7. Change in Behavioral Regulation in Exercise Questionnaire (BREQ 2) at 4 months [ Time Frame: 4 months ]
    A 19 item questionnaire measuring stages of self determination continuum

  8. Change in Unified Huntington Disease Rating Scale Cognitive battery at 4 months [ Time Frame: 4 months ]
    Disease-specific cognitive function as measured by Unified Huntington Disease Cognitive battery (Stroop, Symbol digit modality and verbal fluency)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306888


Contacts
Contact: Greg Youdan 212-678-3916 gay2104@tc.columbia.edu
Contact: Lori Quinn 212-678-3424 lq2165@tc.columbia.edu

Locations
United States, New York
Columbia University Recruiting
New York, New York, United States, 10027
Contact: Greg Youdan    212-678-3916    gay2014@tc.columbia.edu   
Contact: Lori Quinn    212-678-3424    lq2165@tc.columbia.edu   
Sponsors and Collaborators
Teachers College, Columbia University

Responsible Party: Teachers College, Columbia University
ClinicalTrials.gov Identifier: NCT03306888     History of Changes
Other Study ID Numbers: 546845
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias