Clinical trial NCT06580977: Exploring the Effects of Exercise on Memory and Cognition in Parkinson´s Disease
Official title: Exploring the Effects of Exercise on Memory and Cognition in Parkinson´s Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: German Foundation for Neurology
name: University Hospital Heidelberg
name: Universitätsmedizin Mannheim
name: SRH Kurpfalzkrankenhaus Heidelberg
First posted: 2024-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Besides the disabling cardinal motor symptoms, non-motor symptoms are a common clinical feature of Parkinson's disease (PD). These non-motor symptoms include, amongst others, cognitive decline and memory deficits. A growing body of evidence suggests that cardiovascular training has the potential to induce functional and structural brain changes that can translate into improved cognitive function, including memory. While data is mainly derived from studying rodents and healthy populations, cardiovascular exercise might also counteract cognitive decline and memory deficits in people with Parkinson's disease (pwPD). Therefore, the primary aim of the study is to investigate the effects of a twelve-week cardiovascular training on memory formation in pwPD.

In a randomized controlled trial, 60 persons with mild to moderate PD (i.e., Hoehn \& Yahr ≤3) will either perform moderate-intensity cardiovascular training (experimental group) or stretching (control group) for twelve weeks (three times per week, totaling 36 training sessions; duration per training session 30 to 55 min). Participants will perform a procedural memory task before and after the intervention to analyze the effects on non-declarative memory formation (primary outcome). In addition, secondary and exploratory analyses will include the assessment of episodic memory formation, cognitive function, cardiorespiratory fitness, sleep quality, and BDNF blood concentration levels. The findings of the present study contribute to the current discussion on the neuroplastic effects of cardiovascular training and may have important implications for neurorehabilitation in pwPD.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Non-declarative, procedural memory (motor sequence learning) global learning score - Visuomotor Serial Targeting Task (VSTT)
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
Secondary outcomes:
measure: Non-declarative, procedural memory (motor sequence learning) encoding and consolidation - Visuomotor Serial Targeting Task (VSTT)
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Declarative, episodic memory (verbal learning) - Rey Auditory Verbal Learning Test
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Cognitive function
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Cardiovascular fitness
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Objective sleep efficiency
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Subjective sleep disturbance
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Brain-derived neurotrophic factor (BDNF) blood concentration level
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
Other outcomes:
measure: Non-declarative, procedural memory (motor sequence learning) further variables - Visuomotor Serial Targeting Task (VSTT)
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Sociodemographic & physical characteristics
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Non-motor symptoms (nonmotor experiences of daily living) - Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Motor symptoms (motor examination) - Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Total daily medication - Levodopa equivalent daily dose
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Cognitive status - Montreal Cognitive Assessment
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Quality of life - Parkinson´s Disease Questionnaire-39
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Objective sleep quality
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Subjective sleep quality
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Daytime sleepiness
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Severity of depression - Beck Depression Inventory
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Severity of anxiety - Beck Anxiety Index
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Objective physical activity
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Subjective physical activity last week
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
measure: Subjective physical activity last four weeks
timeFrame: Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention)
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University
state: Baden-Wuerttemberg
Study officials:
affiliation: Heidelberg University
name: Simon Steib, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University
name: Philipp Wanner, Dr.
role: PRINCIPAL_INVESTIGATOR
References: