Exploring the Effects of Exercise on Memory and Cognition in Parkinson´s Disease

NCT06580977 | Recruiting

• 1 other identifier: EMCo
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the effects of cardiovascular (aerobic) training on memory formation and cognitive function in people with Parkinson's disease. Participants will be randomly allocated to one of two groups either performing cardiovascular training (experimental group) or stretching (control group) for twelve weeks, three times a week. The primary aim is to examine whether moderate-intense cardiovascular training (MICT) improves procedural memory formation (primary outcome) compared to stretching. Secondary outcomes include episodic memory formation, cognitive function, cardiorespiratory fitness, sleep quality, and brain-derived neurotrophic factor (BDNF) blood concentration levels.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; rehabilitation; cardiovascular training; aerobic exercise; neuroplasticity; memory; encoding; consolidation; motor learning; acquisition; retention; cognition; sleep; brain-derived neurotrophic factor

Outcome Measures

Primary Outcomes (1)

• Non-declarative, procedural memory (motor sequence learning) global learning score - Visuomotor Serial Targeting Task (VSTT)

  To evaluate non-declarative (procedural) memory formation, a Visuomotor Serial Targeting Task (VSTT) will be used, which is widely applied to study motor sequence learning. A global motor learning score (i.e., \[relative\] change from start of encoding to 24h recall test) will be calculated for explicit (i.e., correct anticipatory movements defined as movements with onset times lower than in random trials and directed to the correct target \[directional error at peak velocity \<22°\]) and implicit (i.e., spatial error to target defined as shortest distance of the movement end point from the center of the target) components of motor sequence learning and the change (delta) in the global motor learning scores from pre- to post-assessment will be analyzed. Hence, two outcome measures from the VSTT are considered to answer the primary research question: (i) change in explicit global motor learning score, and (ii) change in implicit global motor learning score from pre- to post-assessment.

  Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)

Secondary Outcomes (7)

• Non-declarative, procedural memory (motor sequence learning) encoding and consolidation - Visuomotor Serial Targeting Task (VSTT)

  Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)

• Declarative, episodic memory (verbal learning) - Rey Auditory Verbal Learning Test

  Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)

• Cognitive function

  Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)

• Cardiovascular fitness

  Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)

• Objective sleep efficiency

  Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)

Other Outcomes (15)

• Non-declarative, procedural memory (motor sequence learning) further variables - Visuomotor Serial Targeting Task (VSTT)

  Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)

• Sociodemographic & physical characteristics

  Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)

• Non-motor symptoms (nonmotor experiences of daily living) - Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I

  Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)

Study Arms (2)

cardiovascular training

EXPERIMENTAL

The experimental group will perform a cardiovascular training three times a week over 12 weeks.

Behavioral: cardiovascular training

stretching

ACTIVE COMPARATOR

The active control group will perform a stretching training three times a week over 12 weeks.

Behavioral: stretching

Interventions

cardiovascular training BEHAVIORAL

Cardiovascular training will be performed in supervised sessions and in small groups of 2-5 persons at the study site. The training is performed on a cycle ergometer at 60% of peak power output (Wmax) for 30 min (i.e., 5 min warm-up, 20 min at 60% Wmax, 5 min cool-down) three times a week for twelve weeks. The exercise program will be increased by 5 min (max. 55 min) and 5% of intensity (in Watt) every two weeks. If participants report a too low (i.e., Borg scale ≤ 11) or too high (i.e., Borg scale ≥ 16) subjective rate of perceived exertion (RPE; Borg scale 6-20) intensity will be increased or decreased until the target levels are met (i.e., Borg scale 12-15). During training, heart rate, intensity (in Watt) and RPE will be monitored. Participants missing training sessions will be offered an additional week to perform up to three training sessions.

cardiovascular training

stretching BEHAVIORAL

The stretching training will be performed in supervised sessions and in small groups of 2-5 persons at the study site. Stretching training consists of lying, seated, and standing flexibility exercises (according to the recommendations of the American Parkinson´s Disease Foundation and the Parkinson Society Canada) for 30 min (i.e., 5 min warm-up, 20 min main part, 5 min cool-down) three times a week for twelve weeks. The exercise program will be increased by 5 min (i.e., adding additional repetitions and exercises; max. 55 min) every two weeks. Intensity of stretching exercises will be assessed by subjective rate of perceived muscle tension on a visual analog scale (VAS) from 0 to 10 and will be moderate defined as 5 to 7 on the VAS. During training VAS, heart rate, and RPE will be monitored. Participants missing training sessions will be offered an additional week to perform up to three training sessions.

stretching

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed Parkinson's disease
• Disease stage ≤3 on the Hoehn \& Yahr scale
• Age ranging from 50 - 80 years
• Naive to the memory tasks (primary outcomes)
• Ability to stand and walk at least 10 meters independently

You may not qualify if:

• Atypical Parkinsonism
• Significant level of cognitive impairment (i.e., Montreal Cognitive Assessment \<21)
• Deep brain stimulation or brain pacemaker
• Diagnosed psychiatric illness
• Known clinically relevant neurological, internal or orthopedic conditions besides Parkinsonism that would interfere with the exercise paradigm
• Exceeding the recommended level of cardiovascular exercise for older adults (i.e., cardiovascular exercise done ≥150 min per week of moderate-intensity or ≥75 min per week of vigorous-intensity)

Sponsors & Collaborators

• Heidelberg University: lead
• German Foundation for Neurology: collaborator
• University Hospital Heidelberg: collaborator
• Universitätsmedizin Mannheim: collaborator
• SRH Kurpfalzkrankenhaus Heidelberg: collaborator

Study Sites (1)

Heidelberg University

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Links

• Project website

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Simon Steib, Prof. Dr.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

• Philipp Wanner, Dr.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Steib, Prof. Dr.

CONTACT

+49 6221/544643; simon.steib@issw.uni-heidelberg.de

Philipp Wanner, Dr.

CONTACT

+49 6221/544633; philipp.wanner@issw.uni-heidelberg.de

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: Prof. Dr.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: August 30, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study and publication of the primary outcome for at least ten years
• Access Criteria: open data (presumably CC-BY Attribution 4.0 International licence)

Locations

DE (1)