Exploring the Effects of Exercise on Memory and Cognition in Parkinson´s Disease
NCT06580977, Not applicable, Recruiting, Heidelberg University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Exploring the Effects of Exercise on Memory and Cognition in Parkinson´s Disease | ClinicalTrials.gov |
| NCT number | NCT06580977 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Heidelberg University | ClinicalTrials.gov |
| Conditions | Parkinson Disease | ClinicalTrials.gov |
| Interventions | cardiovascular training, stretching | ClinicalTrials.gov |
| First posted | 2024-08-30 | ClinicalTrials.gov |
| Last updated | 2024-08-30 | ClinicalTrials.gov |
Registered outcomes 23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Other | 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) | In addition to the (a) number of correct anticipatory movements and (b) spatial error to target (i.e., primary outcomes), (i) onset time (i.e., time between target display and out movement start), (ii) movement time (i.e., time from out movement start to end), (iii) peak velocity, (iv) directional error at peak velocity (i.e., angular deviation between real and ideal movement trajectory at peak velocity), (v) spatial error to ideal movement (i.e., root mean squared error between real and ideal movement trajectory), and (vi) normalized hand-path area (i.e., area enclosed by the out and in movement divided by the squared path length) will be inspected to analyze practice-related changes in temporal and kinematic movement characteristics. | ClinicalTrials.gov |
| Other | Sociodemographic & physical characteristics | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | 1. Age, biological sex 2. Years of education 3. Height, weight, body mass index 4. Handedness (Edinburgh Handedness Inventory) | ClinicalTrials.gov |
| Other | 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) | Movement Disorder Society Unified Parkinson's Disease Rating Scale (UPDRS) Part I total score (0-52) | ClinicalTrials.gov |
| Other | Motor symptoms (motor examination) - Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | Movement Disorder Society Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score (0-132) | ClinicalTrials.gov |
| Other | Total daily medication - Levodopa equivalent daily dose | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | Total levodopa equivalent daily dose (LEDD) in mg | ClinicalTrials.gov |
| Other | Cognitive status - Montreal Cognitive Assessment | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | Montreal Cognitive Assessment (MoCA) total score (0-30 points) | ClinicalTrials.gov |
| Other | Quality of life - Parkinson´s Disease Questionnaire-39 | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | Parkinson´s Disease Questionnaire-39 (PDQ-39) dimension scores (0-100) and total score (0-100) | ClinicalTrials.gov |
| Other | Objective sleep quality | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | Actigraphy (wrist-worn accelerometer for seven days and nights): sleep onset latency, total sleep time, wake after sleep onset, number of awakenings | ClinicalTrials.gov |
| Other | Subjective sleep quality | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | Pittsburgh Sleep Quality Index (PSQI) total score (0-21 points) | ClinicalTrials.gov |
| Other | Daytime sleepiness | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | Epworth Sleepiness Scale (ESS) total score (0-10 points) | ClinicalTrials.gov |
| Other | Severity of depression - Beck Depression Inventory | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | Beck Depression Inventory (BDI) total score (0-63) | ClinicalTrials.gov |
| Other | Severity of anxiety - Beck Anxiety Index | Week 1-2: pre-assessment (baseline within two weeks before intervention), Week 15-16: post-assessment (within two weeks after intervention) | Beck Anxiety Index (BAI) total score (0-63) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Motor Sequence Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)