Exercise & Brain Energetics in PD

NCT04426786 | Recruiting

• 1 other identifier: H19-01839
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There is increasing evidence that the usage and delivery of energy to the brain, known as brain energetics, is altered in people with Parkinson's disease (PD). This project will explore whether exercise has a positive impact on brain energetics using functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) brain scanning in PD subjects. PD subjects will be scanned before and after a supervised exercise program to investigate the effect of exercise on brain energetics. In a separate study, the investigators will also scan healthy volunteers to compare brain energetics in the healthy brain with the brain energetics data in PD subjects acquired in this study.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Exercise; Brain energetics; Positron Emission Tomography; MRI; PET

Outcome Measures

Primary Outcomes (1)

• PET/MRI

  CMRO2 will be computed from MRI data and CMRGlu from PET data; their ratio will be used to assess brain energetics.

  Six months

Other Outcomes (2)

• Clinical measure: motor function

  Six months

• Clinical measure: cognitive function

  Six months

Study Arms (2)

Immediate intervention start: active exercise

ACTIVE COMPARATOR

Immediately starts the six month intervention of active exercise following the baseline scan.

Other: Active exercise

Delayed intervention start: passive exercise

PLACEBO COMPARATOR

Starts the six month intervention of active exercise six months after the baseline scan. During the six month delay, participants in this arm undergo passive exercise.

Other: Active exercise; Other: Passive exercise

Interventions

Active exercise OTHER

Thrice-weekly supervised intense aerobic exercise classes on cycle ergometers, in groups, for six months. Percentage of VO2 max will be used to regulate exercise intensity, based on an initial aerobic exercise test.

Delayed intervention start: passive exercise; Immediate intervention start: active exercise

Passive exercise OTHER

Thrice-weekly supervised passive exercise classes consisting of stretching and/or yoga, in groups, for six months.

Delayed intervention start: passive exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate Parkinsonism (Hoehn \& Yahr stages I-III)
• Currently exercise less than 120 minutes per week (PD non-exercisers)

You may not qualify if:

• atypical Parkinson syndrome (progressive supranuclear palsy, multiple system atrophy, drug-induced etc.);
• significant osteoporosis or arthritis;
• history of cancer within 5 years of study participation;
• high dose of radiation from other procedures within the year;
• not able to tolerate being off PD medication for up to 24 hours;
• a female subject who is breast-feeding or pregnant;
• current or past substance use problems;
• serious head injury with loss of consciousness for ≥ 5 minutes;
• people with other chronic diseases such as diabetes, kidney problems, high blood pressure, other known neurological disorders, or heart diseases;
• people who report having a significant respiratory disorder (e.g. asthma, chronic obstructive pulmonary disease (COPD)) or using home oxygen will be excluded to avoid discomfort or breathing difficulties from respiratory manipulations.
• current or past neurological disorder (e.g. strokes, seizures, neurodegenerative disease other than Parkinson's disease);
• current or past psychiatric disorders (e.g. depression, anxiety disorders);
• severe claustrophobia (a fear of closed in spaces);
• weight of more than 158kg (347 lbs);
• inability to lay still for up to 90 minutes;

Sponsors & Collaborators

• Pacific Parkinson's Research Centre: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T 2B5, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vesna Sossi

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessamyn McKenzie

CONTACT

604 822 7764; jess.mckenzie@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 11, 2020
• Study Start: January 26, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)