Huntington's DiseasePhase 1/2NCT03306888
Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage HD
A Phase 1/2 study testing Physical Activity Coaching in people with Huntington's Disease, run by Teachers College, Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Huntington's Disease
- What is being tested?
- Physical Activity Coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2017to 1 Apr 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage Huntington's Disease
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.
Read the 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.
- Conditions
- Huntington's Disease
- Being tested
- Physical Activity Coaching
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity CoachingOther
Physical activity coaching over 4 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical Activity Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity (daily step counts) at 4 months
Physical activity as measured by waist worn device (Actigraph)
Measured: 4 months
Secondary outcomes (8)
Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months
Questionnaire evaluating level of physical activity over past 7 days
Measured: 4 months
Change in Lorig self efficacy scale at 4 months
Self efficacy questionnaire
Measured: 4 months
Change in 6 minute walk distance at 4 months
Endurance measured by 6 minute walk test - distance completed over 6 minutes of walking
Measured: 4 months
Change in grip strength at 4 months
Hand strength as measured with hand held dynamometer
Measured: 4 months
Change in HD-PRO-TRIAD at 4 months
Questionnaire evaluating disease-specific measure of HD symptoms (cognitive, emotional and motor function)
Measured: 4 months
Change in Unified Huntington Disease rating scale Total Motor Score at 4 months
Disease-specific measure of motor function
Measured: 4 months
Change in Behavioral Regulation in Exercise Questionnaire (BREQ 2) at 4 months
A 19 item questionnaire measuring stages of self determination continuum
Measured: 4 months
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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start10 Oct 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm feasibility study with 14 participants
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306888
- Sponsor's protocol ID
- 546845
- Status last verified
- Nov 2018
- First submitted
- 2 Oct 2017
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Implementing a Clinic-based Physical Activity Coaching Intervention in People With Premanifest and Early Stage Huntington's Disease
- ClinicalTrials.gov ID
- NCT03306888
- Acronym / sponsor ID
- 546845
- Conditions
- Huntington's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm feasibility study with 14 participants
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Coaching Intervention | Experimental | Other: Physical Activity CoachingThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity CoachingPhysical activity coaching over 4 months | Other | Physical Activity Coaching Intervention |
Primary outcome
Change in physical activity (daily step counts) at 4 months
Time frame: 4 months
Physical activity as measured by waist worn device (Actigraph)
8 secondary outcomes
Change in International Physical Activity Questionnaire (IPAQ) metabolic equivalent of task at 4 months
Time frame: 4 months
Change in Lorig self efficacy scale at 4 months
Time frame: 4 months
Change in 6 minute walk distance at 4 months
Time frame: 4 months
Change in grip strength at 4 months
Time frame: 4 months
Change in HD-PRO-TRIAD at 4 months
Time frame: 4 months
Change in Unified Huntington Disease rating scale Total Motor Score at 4 months
Time frame: 4 months
Change in Behavioral Regulation in Exercise Questionnaire (BREQ 2) at 4 months
Time frame: 4 months
Change in Unified Huntington Disease Rating Scale Cognitive battery at 4 months
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Physical Activity Coaching in people with Huntington's Disease, run by Teachers College, Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity (daily step counts) at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.