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

Primary Purpose

Huntington's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Coaching
Sponsored by
Teachers College, Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Huntington's Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity Coaching Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in physical activity (daily step counts) at 4 months
Physical activity as measured by waist worn device (Actigraph)

Secondary Outcome Measures

Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months
Questionnaire evaluating level of physical activity over past 7 days
Change in Lorig self efficacy scale at 4 months
Self efficacy questionnaire
Change in 6 minute walk distance at 4 months
Endurance measured by 6 minute walk test - distance completed over 6 minutes of walking
Change in grip strength at 4 months
Hand strength as measured with hand held dynamometer
Change in HD-PRO-TRIAD at 4 months
Questionnaire evaluating disease-specific measure of HD symptoms (cognitive, emotional and motor function)
Change in Unified Huntington Disease rating scale Total Motor Score at 4 months
Disease-specific measure of motor function
Change in Behavioral Regulation in Exercise Questionnaire (BREQ 2) at 4 months
A 19 item questionnaire measuring stages of self determination continuum
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)

Full Information

First Posted
October 2, 2017
Last Updated
May 29, 2019
Sponsor
Teachers College, Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03306888
Brief Title
Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage HD
Official Title
Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage Huntington's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teachers College, Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single arm feasibility study with 14 participants
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Coaching Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Activity Coaching
Intervention Description
Physical activity coaching over 4 months
Primary Outcome Measure Information:
Title
Change in physical activity (daily step counts) at 4 months
Description
Physical activity as measured by waist worn device (Actigraph)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months
Description
Questionnaire evaluating level of physical activity over past 7 days
Time Frame
4 months
Title
Change in Lorig self efficacy scale at 4 months
Description
Self efficacy questionnaire
Time Frame
4 months
Title
Change in 6 minute walk distance at 4 months
Description
Endurance measured by 6 minute walk test - distance completed over 6 minutes of walking
Time Frame
4 months
Title
Change in grip strength at 4 months
Description
Hand strength as measured with hand held dynamometer
Time Frame
4 months
Title
Change in HD-PRO-TRIAD at 4 months
Description
Questionnaire evaluating disease-specific measure of HD symptoms (cognitive, emotional and motor function)
Time Frame
4 months
Title
Change in Unified Huntington Disease rating scale Total Motor Score at 4 months
Description
Disease-specific measure of motor function
Time Frame
4 months
Title
Change in Behavioral Regulation in Exercise Questionnaire (BREQ 2) at 4 months
Description
A 19 item questionnaire measuring stages of self determination continuum
Time Frame
4 months
Title
Change in Unified Huntington Disease Rating Scale Cognitive battery at 4 months
Description
Disease-specific cognitive function as measured by Unified Huntington Disease Cognitive battery (Stroop, Symbol digit modality and verbal fluency)
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States

12. IPD Sharing Statement

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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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