Exploring the Effects of Exercise on Memory and Cognition in Parkinson´s Disease
- Conditions
- Parkinson Disease
- Interventions
- Behavioral: cardiovascular trainingBehavioral: stretching
- Registration Number
- NCT06580977
- Lead Sponsor
- Heidelberg University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cardiovascular training cardiovascular training The experimental group will perform a cardiovascular training three times a week over 12 weeks. stretching stretching The active control group will perform a stretching training three times a week over 12 weeks.
- Primary Outcome Measures
Name Time Method Non-declarative, procedural memory (motor sequence learning) global learning score - 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) 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.
- Secondary Outcome Measures
Name Time Method 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) To evaluate the effects on the different processes of non-declarative (procedural) memory formation, the encoding (i.e., relative change in performance from beginning to end of practice) and consolidation (i.e., relative change in performance from end of practice to a 24h recall test) of the motor sequence will be investigated for the implicit and explicit components, respectively. This results in four secondary outcome variables for the VSTT: (i) change in encoding of the explicit component from pre- to post assessment; (ii) change in encoding of the implicit component from pre- to post assessment; (iii) change in consolidation of the explicit component from pre- to post assessment; (iv) change in consolidation of the implicit component from pre- to post-assessment.
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) To evaluate the effects on declarative (episodic) memory, the German version of the Rey Auditory Verbal Learning Test will be used. Similar to non-declarative (procedural) memory (i) the change in global episodic learning score (i.e., correctly recalled words at 24 h recall test) from pre- to post-intervention will be analyzed in a first step followed by a separate analysis of (ii) the change in encoding (i.e., correctly recalled words after listening five times to the wordlist) from pre- to post-intervention and (iii) the change in consolidation (i.e., change in correctly recalled words from end of encoding to recall test) from pre- to post-intervention.
Cognitive function Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) To evaluate the effects on cognitive function, the domains: (i) short-term memory (Digit and Spatial Span Task forward: length of correctly reproduced sequence of digits/locations), (ii) working memory (Digit and Spatial Span Task backward: length of correctly reproduced sequence of digits/locations), (iii) inhibition (Stroop Test interference score: number of correctly named colors in the color-word condition compared to the predicted color-word score), and (vi) cognitive flexibility (Trail Making Test A \& B trail flexibility score: time to complete test B compared to test A) will be assessed. A composite score including all domains to analyze change in global cognitive function from pre- to post-assessment will be calculated followed by a separate analysis of the change in the individual test scores from pre- to post-assessment.
Cardiovascular fitness Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) To evacuate the effects on cardiorespiratory fitness, a graded exercise test (GXT) on a cycle ergometer with spiroergometry will be performed and the change in peak oxygen consumption (VO2peak) from pre- to post intervention will be analyzed.
Objective sleep efficiency Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) To evaluate the effects on objective sleep quality, the change in sleep efficiency from pre- to post-assessment using wrist-worn actigraphy (ActiGraph GT9X; ActiGraph; Pensacola; USA) will be assessed.
Subjective sleep disturbance Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) To evaluate the effects on subjective sleep quality, the change in subjective disease-related sleep disturbance from pre- to post-assessment using the Parkinson's Disease Sleep Scale 2 (PDDS-2) total score will be assessed.
Brain-derived neurotrophic factor (BDNF) blood concentration level Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) To evaluate the effects on brain-derived neurotrophic factor (BDNF), serum blood samples at rest will be collected and the change from pre- to post-assessment will be analyzed.
Trial Locations
- Locations (1)
Heidelberg University
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany