Clinical trial NCT05270681: Move to Improve: Telehealth Exercise to Music for HD
Official title: Move to Improve: Telehealth Exercise and Music Intervention for Individuals With Huntington's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Huntington Disease
Keywords: Huntington
HD
Exercise
Telehealth
Dance
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Huntington's Disease Society of America
First posted: 2022-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a movement to music exercise program delivered via telehealth is feasible and safe for individuals with neurodegenerative disease and their caregivers (Aim 1). A secondary aim will be to determine if a movement to music exercise program delivered via telehealth improves balance, cognition, mobility, and quality of life (Aim 2).

Detailed description: The purpose of this study is to determine if a movement to music exercise program created for our clinic patients, called "Move to Improve," delivered via telehealth is possible and safe for individuals with neurodegenerative disease. Investigators also hope to determine if this telehealth movement to music exercise program improves balance, cognition, mobility, and quality of life. Participants will be asked to participate in a movement to music exercise program that will be accessible by video twice a week for 12 weeks and complete assessments before starting and after completing the program. Participants will be recruited from the OSU Neurology Clinic which serves a large regional area, including rural Appalachian counties. Participants will be ages 21 or older with a confirmed diagnosis of a degenerative neurologic disorder such as Huntington's disease who can access a computer, tablet, or smartphone, can complete the exercises, and have a care partner. Participants will be educated on how to access prerecorded Move to Improve classes conducted by a professional dance instructor which are accessible by computer or tablet 24/7 via a hyperlink. This link will be accessible to the community. Here is a link to an example of the class lead by the instructor for this study: https://www.youtube.com/watch?v=NdoPi9YXoWg. Classes last 45 minutes, and participants will be instructed to participate in the activity at least twice weekly, for 12 weeks. Each class uses movement to music combinations across different dance genres that build in intensity and sequence complexity, accompanied by music with faster beats, to encourage participants to achieve a moderate-vigorous level of physical and cognitive activity. Care givers will be also participate in the exercise class and will be present to ensure safety. The care giver and participant will be instructed to stand at a counter or behind a chair for safety during exercise. Participants within driving distance will come to the MEND lab for in-person outcome measures at baseline and after the 12 week intervention. Assessments will also be administered to all participants via telehealth. For those individuals who are not able to come to the lab for assessment due to distance or other reasons, tests will only be administered via telehealth. These individuals will be consented via phone. Telehealth exercise classes will be conducted using a virtual meeting platform such as Zoom, Microsoft Teams, or FaceTime. Caregivers will be present during all assessments to ensure safety.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of a degenerative neurologic disorder such as HD, PD, mild dementia or mild cognitive impairment
* above the age of 21 years
* has a care partner who can assist with the program.
* able to access the online exercise program
* able to understand study and provide consent.
* stable medication regime for four weeks prior to initiation of trial, and anticipated to be able to maintain a stable regime for the course of trial
* OR regularly assisting in the care for an individual that meet the above criteria (for care partners)

Exclusion Criteria:

* any physical or psychiatric condition that would prohibit the participant from completing the intervention or the full battery of assessments
* unable to understand or communicate in spoken English
* currently involved in any intervention trial or within four weeks of completing an intervention trial
* current, regular participation in a structured exercise program three times per week or more

Primary outcomes:
measure: Change in 4 stage balance test from baseline: feet together from baseline
timeFrame: 12 weeks
measure: Change in 4 stage balance test from baseline: feet together from baseline - TELEHEALTH
timeFrame: 12 weeks
measure: Change in 4 stage balance test from baseline: feet staggered from baseline
timeFrame: 12 weeks
measure: Change in 4 stage balance test from baseline: feet staggered from baseline - TELEHEALTH
timeFrame: 12 weeks
measure: Change in 4 stage balance test from baseline: feet in tandem from baseline
timeFrame: 12 weeks
measure: Change in 4 stage balance test from baseline: feet in tandem from baseline - TELEHEALTH
timeFrame: 12 weeks
measure: Change in 4 stage balance test from baseline: single leg stance from baseline
timeFrame: 12 weeks
measure: Change in 4 stage balance test from baseline: single leg stance from baseline - TELEHEALTH
timeFrame: 12 weeks
measure: Change in 5 Times Sit to Stand Test from baseline
timeFrame: 12 weeks
measure: Change in 5 Times Sit to Stand Test from baseline - TELEHEALTH
timeFrame: 12 weeks
measure: Change in Adapted Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire from baseline
timeFrame: 12 weeks
measure: Change in Patient Health Questionnaire (PHQ-9) from baseline
timeFrame: 12 weeks
measure: Change in Patient Health Questionnaire (PHQ-9) from baseline - TELEHEALTH
timeFrame: 12 weeks
measure: Change in 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire from baseline
timeFrame: 12 weeks
measure: Change in 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire from baseline - TELEHEALTH
timeFrame: 12 weeks
measure: Change in verbal fluency from baseline
timeFrame: 12 weeks
measure: Change in verbal fluency from baseline - TELEHEALTH
timeFrame: 12 weeks
measure: Change in Digit Span test from baseline
timeFrame: 12 weeks
measure: Change in Digit Span test from baseline - TELEHEALTH
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Unified Huntington's Disease Rating Scale (UHDRS) Motor Scale from baseline
timeFrame: 12 weeks
measure: Change in Unified Huntington's Disease Rating Scale (UHDRS) Functional Assessment scale from baseline
timeFrame: 12 weeks
measure: Change in Unified Huntington's Disease Rating Scale (UHDRS) Independence scale from baseline
timeFrame: 12 weeks
measure: Change in Symbol Digit Modality Test (SDMT) from baseline
timeFrame: 12 weeks
measure: Change in the Stroop interference test from baseline
timeFrame: 12 weeks
Other outcomes:
measure: Open-ended questionnaire
timeFrame: 12 weeks
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References: