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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306888
• Other study ID #: 546845
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 10, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: November 2018
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Other:
• Physical Activity Coaching
Physical activity coaching over 4 months

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teachers College, Columbia University

Country where clinical trial is conducted

United States, 

Outcome

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