Home Exercise for Individuals With Neurodegenerative Disease

Neurodegenerative Diseases Clinical Trial

Official title:

Study of Adapted Exercise and Mindfulness Interventions to Improve Motor Function and Sleep Quality in Individuals With Neurodegenerative Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443906
• Other study ID #: JHSOM_IRB00309985
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: July 30, 2027

Study information

• Verified date: March 2024
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: Dandre Amos, BS
• Phone: 443-923-2769
• Email: amosd[@]kennedykrieger.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of this study is to address the need for targeted therapeutic interventions for impairments that impact walking in related neurodegenerative diseases.

Description:

This study will inform clinicians in quantitatively assessing baseline disease severity, selectively applying the appropriate exercise to the disease pathology, and measuring efficacy of the exercise intervention.

As part of this overall goal, the aims are to:

A. Determine feasibility of remotely supervised exercise programs. B. Optimize remote outcome measures for clinical monitoring and towards future clinical trials.

C. Measure changes in balance and walking post intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 30, 2027
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 75 Years

Eligibility

Inclusion Criteria:

• The eligibility criteria for males is X-linked adrenoleukodystrophy as determined by biochemical determination or genetic testing.

• The eligibility criteria for females is X-linked adrenoleukodystrophy as determined by biochemical determination, genetic testing, or pedigree analysis.

• The Leukoenceophalopathy with brainstem and spinal cord involvement and lactate elevation inclusion criterion is a confirmed DARS2 mutation through genetic analysis.

• For people with cerebellar ataxia, people with diagnoses of cerebellar damage from stroke, tumor or degeneration will be included. Those with a genetically confirmed cerebellar disorder will be asked to provide their genetic testing to note their particular type of ataxia.

• We will also include patients with other neurodegenerative diseases similar to these disorders as determined by chart review and clinical exam.

Healthy Volunteers

• Able to stand for 30 seconds without upper extremity support

• Ambulatory (including use of a cane or a walker)

• Able to walk for 2 minutes

Exclusion Criteria:

• Other medical or psychological conditions which in the clinical judgement of the investigator would interfere with acquiring the study information or performing the exercises safely including but not limited to:

Uncontrolled hypertension, orthopedic conditions, diabetes, seizure disorder, peripheral vestibular loss, severe aphasia, dementia, pregnancy

Related Conditions & MeSH terms

• Adrenoleukodystrophy
• Adrenomyeloneuropathy
• Ataxia
• Cerebellar Ataxia
• LBSL
• Leukodystrophy
• Leukoencephalopathies
• Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation
• Neurodegenerative Diseases

Intervention

Behavioral:
• Home exercise
Exercise to address limitations impacting walking

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Keller JL, Fritz N, Chiang CC, Jiang A, Thompson T, Cornet N, Newsome SD, Calabresi PA, Zackowski K. Adapted Resistance Training Improves Strength in Eight Weeks in Individuals with Multiple Sclerosis. J Vis Exp. 2016 Jan 29;(107):e53449. doi: 10.3791/53449. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in NeuroQOL lower extremity	Patient reported outcome	baseline 12 weeks