Aerobic Exercise and Brain Health in Parkinson's

NCT04379778 | Completed DMC

• 1 other identifier: Brain Health in Parkinson's
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the project is to investigate how moderate to high intensity aerobic exercise affects brain health in patients with Parkinson's disease. Assessments include MRI, blood markers, cognition, functional tests, questionnaires, and cardiorespiratory fitness. The study will be a single blinded randomized controlled trial with a 6-month long intervention.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• R2* MRI change

  Effective transverse relaxation rate (R2\*)

  0, 24 and 48 weeks

Secondary Outcomes (15)

• QSM MRI change

  0, 24 and 48 weeks

• DKI MRI change

  0, 24 and 48 weeks

• Neuromelanin MRI change

  0, 24 and 48 weeks

• Volumetry MRI change

  0, 24 and 48 weeks

• Change in blood markers (e.g. α-synuclein)

  0, 24 and 48 weeks

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

Moderate to high intensity aerobic exercise for 24 weeks.

Other: Aerobic exercise

Standard care

NO INTERVENTION

Habitual lifestyle including standard care.

Interventions

Aerobic exercise OTHER

Progressive moderate to high intensity aerobic exercise.

Aerobic exercise

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Age ≥ 40 years
• Idiopathic PD diagnosis (within the previous five years)
• Hoehn \& Yahr ≤ 3
• Ability to transport oneself to and from exercise and testing

You may not qualify if:

• Alcohol abuse, depression, pacemaker
• Comorbidity/competing (neurological) disorder preventing participation in the intervention
• Pregnancy
• Metallic implants that prevent MRI.
• Expected exercise adherence below 85% of all planned sessions.
• Systematic moderate-high-level AE more than twice per week prior to start-up in the project

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Sport Science, Department of Public Health, Aarhus University

Aarhus, Aarhus C, 8000, Denmark

Location

Related Publications (2)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Martin Langeskov-Christensen, Ph.d.

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 7, 2020
• Study Start: March 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 8, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)