Exercise Targeting Cognitive Impairment in Parkinson's Disease

NCT02267785 | Unknown

• 1 other identifier: HS-14-00422
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.

Conditions

Parkinson's Disease

Keywords

exercise; mild cognitive impairment; Parkinson's Disease

Outcome Measures

Primary Outcomes (5)

• Change in Context Dependent Motor Learning (CDML)

  All subjects from each group will undergo a finger sequence motor learning task to determine exercise effects on EF as evaluated through improvement in the transfer of a learned motor task from one contextual setting to another.

  at Baseline, after 12 week intervention, and at 12 week follow up visit

• Change in Dual Task Performance and Functional Magnetic Resonance Imaging (fMRI)

  A subset of subjects (60 representing 20 per group) will be invited to undergo fMRI studies at University of California, Los Angeles. Patients will perform a learned single finger-sequencing task (a condition of the CDML) with an additional secondary dual task (DT) component during an fMRI scan.

  at Baseline, after 12 week intervention

• Change in D-KEFS Verbal Fluency Test

  The D-KEFS Verbal Fluency test will be used to evaluate executive function

  at Baseline, after 12 week intervention, and at 12 week follow up visit

• Change in Tower of London Test

  The Tower of London test will be used to evaluate executive function

  at Baseline, after 12 week intervention, and at 12 week follow up visit

• Change in Wisconsin Card Sorting Test

  The Wisconsin Card Sorting test will be used to evaluate executive function

  at Baseline, after 12 week intervention, and at 12 week follow up visit

Secondary Outcomes (27)

• Change in Parkinson Disease Questionnaire-39 (PDQ-39)

  at Baseline, after 12 week intervention, and at 12 week follow up visit

• Change in Evaluation of PD Motor Symptoms with Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  at Baseline, after 12 week intervention, and at 12 week follow up visit

• Change in Activity Specific Balance Confidence (ABC) Scale

  at Baseline, after 12 week intervention, and at 12 week follow up visit

• Change in Confidence in ability to maintain an exercise program (CONF)

  at Baseline, after 12 week intervention, and at 12 week follow up visit

• Change in Exercise Control Beliefs (BEL)

  at Baseline, after 12 week intervention, and at 12 week follow up visit

Study Arms (3)

Skill-Based Exercise

EXPERIMENTAL

Participants assigned to this arm will complete the Skill-Based Exercise Intervention

Other: Skill-Based Exercise

Aerobic Exercise

EXPERIMENTAL

Participants assigned to this arm will complete the Aerobic Exercise Intervention

Other: Aerobic Exercise

Social Contact Group

EXPERIMENTAL

Participants assigned to this arm will complete the Social Contact Intervention

Other: Social Contact

Interventions

Skill-Based Exercise OTHER

The skill-based exercise program is designed to improve skilled function, fine and gross- motor body coordination. The intervention will be focused on acquisition and improvement of complex movements for the whole body and include the following general categories of activities: (1) balance, (2) eye-hand coordination, (3) leg-arm coordination; 4) reaction time to moving objects/persons; (5) dynamic gait and 6) functional activity performance. The treating therapist will direct both general principles of progression and progression specific to each category.

Skill-Based Exercise

Aerobic Exercise OTHER

The aerobic cardiovascular exercise will consist of 36 1-hour sessions performed 3 times weekly over 12 weeks. Aerobic exercise will consist of cycling on a recumbent stationary bicycle. Each session will begin and end with gentle stretching. Continuous cycling will be performed for 45-50 minutes, with the first and last 5 minutes designated as warm-up and cool-down periods. The intensity of the middle 30 minutes of cycling will be increased progressively from an initial target of 50% maximum heart rate (HR) during week 1 to 75% of maximum HR by week 12. The initial intensity will be set at 50% of maximum HR. Participants will be encouraged to cycle as fast as they can, with a goal of maintaining 90 revolutions per minute (RPM) throughout the middle 30-minute period. Pedaling resistance will be kept low throughout all sessions. Measures of heart rate via heart rate monitors, blood pressure, RPM, and rate of perceived exertion will be recorded at 5-minute intervals.

Aerobic Exercise

Social Contact OTHER

The control Social Contact group will consist of an equal amount of social contact as the exercise group. Subjects will have weekly visits at the University of Southern California with the study coordinator. The goal is for 3 hours of social contact every week for a total of 36 hours over 12 weeks. Activities scheduled for the social contact visits will include: (1) support group interactions and (2) social outings such as a trip to a museum, local café for lunch or dinner; (3) book club; (4) sports event. Support group interaction can include discussions among patients and caregivers, presentations from experts in various aspects of PD. They will be instructed to continue with their usual level of activity but refrain from beginning new exercise activities during the study period.

Social Contact Group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• willing and able to provide informed consent
• confirmed diagnosis of idiopathic PD based on the United Kingdom Brain Bank criteria
• Mild cognitive impairment (Level II criteria Movement Disorder Task Force)
• medically eligible for MRI imaging
• able to provide a written medical clearance from their primary physician to participate in exercise
• stable PD medications for 3 months

You may not qualify if:

• a Hoehn \& Yahr staging greater than 2.5 at screening
• severe cardiac disease (New York Heart Association classification IIIV)
• history of an abnormal stress test
• clinically significant medical or psychiatric illness
• electrically, magnetically, or mechanically activated implant (such as cardiac pacemakers or intracerebral vascular clip)
• metal in any part of the body including metal injury to the eye
• past history of brain lesions (such as stroke)
• seizures or unexplained spells of loss of consciousness
• family history of epilepsy
• physical therapy within 6 months of the study
• symptomatic orthostatic hypotension at the screening visit
• orthopedic and other movement-influencing diseases such as arthritis or total hip joint replacement
• requirement for central nervous system active therapies (e.g. hypnotics, antidepressants, anxiolytics)
• moderate or severe depression or apathy using the Geriatric depression scale and Apathy scale
• taking anticholinesterase inhibitors

Sponsors & Collaborators

• University of Southern California: lead
• National Parkinson Foundation: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90033-4606, United States

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; Motor Activity; Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Giselle M Petzinger, MD

  University of Southern California

  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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 31, 2019

Record last verified: 2019-05

Locations

US (1)