NCT05270681

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2024

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

February 25, 2022

Last Update Submit

July 28, 2025

Conditions

Keywords

HuntingtonHDExerciseTelehealthDance

Outcome Measures

Primary Outcomes (19)

  • Change in 4 stage balance test from baseline: feet together from baseline

    How long a participant can stand with feet together up to 10 seconds

    12 weeks

  • Change in 4 stage balance test from baseline: feet together from baseline - TELEHEALTH

    How long a participant can stand with feet together up to 10 seconds collected via telehealth

    12 weeks

  • Change in 4 stage balance test from baseline: feet staggered from baseline

    How long a participant can stand with feet staggered up to 10 seconds

    12 weeks

  • Change in 4 stage balance test from baseline: feet staggered from baseline - TELEHEALTH

    How long a participant can stand with feet staggered up to 10 seconds collected via telehealth

    12 weeks

  • Change in 4 stage balance test from baseline: feet in tandem from baseline

    How long a participant can stand with feet heel to toe up to 10 seconds

    12 weeks

  • Change in 4 stage balance test from baseline: feet in tandem from baseline - TELEHEALTH

    How long a participant can stand with feet heel to toe up to 10 seconds collected via telehealth

    12 weeks

  • Change in 4 stage balance test from baseline: single leg stance from baseline

    How long a participant can stand on one foot to toe up to 60 seconds

    12 weeks

  • Change in 4 stage balance test from baseline: single leg stance from baseline - TELEHEALTH

    How long a participant can stand on one foot to toe up to 60 seconds collected via telehealth

    12 weeks

  • Change in 5 Times Sit to Stand Test from baseline

    How long a participant can stand up and sit down from a standard chair with arms crossed across chest in seconds

    12 weeks

  • Change in 5 Times Sit to Stand Test from baseline - TELEHEALTH

    How long a participant can stand up and sit down from a standard chair with arms crossed across chest in seconds collected via telehealth

    12 weeks

  • Change in Adapted Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire from baseline

    A patient-reported outcome measure that assesses perceived difficulty in completing physical tasks.

    12 weeks

  • Change in Patient Health Questionnaire (PHQ-9) from baseline

    A self-administered instrument for depression module, which scores each of the items as "0" (not at all) to "3" (nearly every day), with higher scores indicating worse depression

    12 weeks

  • Change in Patient Health Questionnaire (PHQ-9) from baseline - TELEHEALTH

    A self-administered instrument for depression module, which scores each of the items as "0" (not at all) to "3" (nearly every day), with higher scores indicating worse depression. Collected via telehealth

    12 weeks

  • Change in 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire from baseline

    A patient reported outcome measure containing 12 items that the participant rates his or her difficulties in maintaining personal care, occupational tasks and functioning in relation to family and society with a score range from 12 to 60, where higher scores indicate higher disability or loss of function.

    12 weeks

  • Change in 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 questionnaire from baseline - TELEHEALTH

    A patient reported outcome measure containing 12 items that the participant rates his or her difficulties in maintaining personal care, occupational tasks and functioning in relation to family and society with a score range from 12 to 60, where higher scores indicate higher disability or loss of function. Collected via telehealth

    12 weeks

  • Change in verbal fluency from baseline

    A measure of cognition that involves asking the participant to name as many animals as they can in 60 seconds and then they are given a letter and asked to name all of the words that begin with that letter in 60 seconds. The more words the better the outcome.

    12 weeks

  • Change in verbal fluency from baseline - TELEHEALTH

    A measure of cognition that involves asking the participant to name as many animals as they can in 60 seconds and then they are given a letter and asked to name all of the words that begin with that letter in 60 seconds. The more words the better the outcome. Collected via telehealth.

    12 weeks

  • Change in Digit Span test from baseline

    A measure of cognition that involves asking the participant to recall a series of numbers. The more numbers recalled accurately the better the outcome.

    12 weeks

  • Change in Digit Span test from baseline - TELEHEALTH

    A measure of cognition that involves asking the participant to recall a series of numbers. The more numbers recalled accurately the better the outcome. Collected via telehealth

    12 weeks

Secondary Outcomes (5)

  • Change in Unified Huntington's Disease Rating Scale (UHDRS) Motor Scale from baseline

    12 weeks

  • Change in Unified Huntington's Disease Rating Scale (UHDRS) Functional Assessment scale from baseline

    12 weeks

  • Change in Unified Huntington's Disease Rating Scale (UHDRS) Independence scale from baseline

    12 weeks

  • Change in Symbol Digit Modality Test (SDMT) from baseline

    12 weeks

  • Change in the Stroop interference test from baseline

    12 weeks

Other Outcomes (1)

  • Open-ended questionnaire

    12 weeks

Study Arms (2)

Individuals with HD

EXPERIMENTAL

Participants with a confirmed diagnosis of Huntington's disease

Other: Movement to Music

Care Partners

EXPERIMENTAL

Participants' care partners

Other: Movement to Music

Interventions

Participants will be educated on how to access prerecorded Move to Improve classes conducted by a professional dance instructor which will be accessible by computer or tablet 24/7 via a hyperlink. 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 partners will be present during each class to ensure safety and will also participate in the Move to Improve exercise program. The care partner and participant will be instructed to stand at a counter or behind a chair for safety during exercise.

Care PartnersIndividuals with HD

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Huntington DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 8, 2022

Study Start

November 8, 2021

Primary Completion

November 14, 2024

Study Completion

November 14, 2024

Last Updated

July 30, 2025

Record last verified: 2025-07

Locations