NCT01879267

Brief Summary

Huntington's disease (HD) is an incurable and fatal disorder characterised by progressive degeneration of the basal ganglia and the cerebral cortex. Contrary to earlier thinking, HD is associated with abnormalities in peripheral tissues which might even contribute to brain pathology including muscle wasting, mitochondrial abnormalities, and impaired muscle energy metabolism. Mitochondrial impairment and muscle atrophy in human HD patients and murine models of HD are associated with altered expression of PGC-1a, a transcriptional cofactor that seems to regulate many, if not all of the adaptations of muscle fibres to chronic endurance training, and induces improved exercise performance and increased peak oxygen uptake. We aim at investigating whether endurance exercise has the capability of stabilizing and / or reversing PGC-1a dependent alterations of muscle function and structure in HD patients, and whether muscle training ameliorates musculoskeletal and cardiovascular function, as well as motor and cognitive symptoms in HD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 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

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

6 years

First QC Date

May 24, 2012

Last Update Submit

June 11, 2018

Conditions

Huntington's Disease

Outcome Measures

Primary Outcomes (1)

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

    Baseline and 6 months

Study Arms (2)

Exercise Training: HD subjects

OTHER

Endurance exercise for 6 months (30 min per week) starting one week after a 6-months natural course observation

Behavioral: Exercise training

Exercise Training: healthy subjects

OTHER

6 months of exercise training (2 times 30 min per week)

Behavioral: Exercise training

Interventions

Exercise trainingBEHAVIORAL

6 months of exercise training (2 times 30 min per week) starting one week after a 6-months natural course observation period

Exercise Training: HD subjectsExercise Training: healthy subjects

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male gender
  • Genetically verified diagnosis of HD
  • Age 30 to 50 years
  • Presence of only mild to moderate neurological, cognitive or muscular impairment allowing the subjects to give their written informed consent and to participate in the endurance training (UHDRS 30 or lower)
  • male gender 9
  • age 30 to 50 years
  • absence of physical or mental illness

You may not qualify if:

  • Female gender
  • Advanced neurological, cognitive or muscular impairment related to HD that does not allow patients to participate in the endurance training and/or to give their written informed consent
  • Cardiovascular disease or any other medical condition that might not be compatible with endurance training
  • CK levels \> 300 U/L
  • cardiovascular disease
  • any other medical condition that might not be compatible with endurance training
  • CK levels \> 300 U/L.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Neurology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Mueller SM, Gehrig SM, Petersen JA, Frese S, Mihaylova V, Ligon-Auer M, Khmara N, Nuoffer JM, Schaller A, Lundby C, Toigo M, Jung HH. Effects of endurance training on skeletal muscle mitochondrial function in Huntington disease patients. Orphanet J Rare Dis. 2017 Dec 19;12(1):184. doi: 10.1186/s13023-017-0740-z.

    PMID: 29258585DERIVED

MeSH Terms

Conditions

Huntington Disease

Interventions

Exercise

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 Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hans H Jung, Professor MD

    University Hospital Zurich, Division of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2012

First Posted

June 17, 2013

Study Start

January 1, 2012

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

June 13, 2018

Record last verified: 2018-06

Locations

CH(1)