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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04120493 -
Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease
|
Phase 1/Phase 2 | |
Completed |
NCT02956148 -
Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers
|
Early Phase 1 | |
Terminated |
NCT02494778 -
A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease
|
Phase 2 | |
Completed |
NCT02197130 -
Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
|
Phase 2 | |
Completed |
NCT02208934 -
Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers
|
Phase 1 | |
Completed |
NCT02216474 -
Brain Stimulation in Movement Disorders
|
N/A | |
Completed |
NCT01806896 -
Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
|
Phase 2 | |
Completed |
NCT01502046 -
Neuroprotection by Cannabinoids in Huntington's Disease
|
Phase 2 | |
Terminated |
NCT00712426 -
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)
|
Phase 3 | |
Completed |
NCT00670709 -
Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease
|
||
Completed |
NCT00029874 -
Minocycline in Patients With Huntington's Disease
|
Phase 1/Phase 2 | |
Terminated |
NCT02231580 -
Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients
|
Phase 2 | |
Completed |
NCT02215616 -
A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod
|
Phase 2 | |
Not yet recruiting |
NCT02551705 -
Functional Imaging of Social Cognition in Premanifest Huntington's Disease
|
N/A | |
Active, not recruiting |
NCT02101957 -
Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)
|
Phase 2/Phase 3 | |
Completed |
NCT01521832 -
Escalating Dose Study in Healthy Volunteers With SEN0014196
|
Phase 1 | |
Completed |
NCT00975481 -
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
|
Phase 1 | |
Completed |
NCT00990613 -
A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin
|
Phase 1 | |
Completed |
NCT00387270 -
Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease
|
Phase 1/Phase 2 | |
Completed |
NCT00095355 -
Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's Disease
|
Phase 2 |