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

NCT03306888 | Completed Phase 1

• 1 other identifier: 546845
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington's Disease

Outcome Measures

Primary Outcomes (1)

• Change in physical activity (daily step counts) at 4 months

  Physical activity as measured by waist worn device (Actigraph)

  4 months

Secondary Outcomes (8)

• Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months

  4 months

• Change in Lorig self efficacy scale at 4 months

  4 months

• Change in 6 minute walk distance at 4 months

  4 months

• Change in grip strength at 4 months

  4 months

• Change in HD-PRO-TRIAD at 4 months

  4 months

Study Arms (1)

Physical Activity Coaching Intervention

EXPERIMENTAL

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

Interventions

Physical Activity Coaching OTHER

Physical activity coaching over 4 months

Physical Activity Coaching Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm feasibility study with 14 participants

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 11, 2017
• Study Start: October 10, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 30, 2019

Record last verified: 2018-11

Locations

US (1)