Periodization and Parkinson's Disease (NCT07141849)
Overview
Mermaid diagram (expand to render)
This clinical trial investigates the effects of block periodization training versus traditional power resistance training on neuromuscular and functional performance in persons with Parkinson's Disease. The study addresses a critical question in exercise prescription for PD: whether systematic periodization—cycling through different training phases—provides superior benefits compared to continuous high-intensity power training["@signorile"].
Periodization is a well-established exercise programming approach in sports science that involves systematic variation of training variables (intensity, volume, and exercise selection) over time. While widely used in athletic populations, its application to neurodegenerative conditions like Parkinson's disease remains poorly understood. This trial represents one of the first efforts to translate periodization principles to PD rehabilitation["@hemmelmann"].
Trial Details
| Parameter | Value |
|-----------|-------|
| NCT Number | NCT07141849 |
| Title | Periodization and Parkinson's Disease |
| Official Title | Comparison of Changes in Neuromuscular and Functional Performance Due to Block Periodization or Traditional Power Training in Persons With Parkinson's Disease |
| Phase | Not Applicable (Interventional) |
| Status | RECRUITING |
| Sponsor | University of Miami |
| Lead Principal Investigator | Joseph Signorile, PhD |
| Enrollment | 60 participants |
| Study Type | INTERVENTIONAL |
| Allocation | Randomized, Parallel Group |
| Masking | None (Open Label) |
| Start Date | August 29, 2025 |
| Primary Completion | December 30, 2025 |
| Last Updated | September 2, 2025 |
Conditions Studied
- Parkinson's Disease (Hoehn & Yahr Stages 1-3)
- Motor Function Impairment
- Sarcopenia (age-related muscle loss, common in PD)
Study Design
Trial Architecture
This is a randomized, controlled, parallel-group trial comparing two resistance training paradigms:
| Design Element | Description |
|----------------|-------------|
| Allocation | Randomized (1:1 ratio) |
| Intervention Model | Parallel |
| Primary Purpose | Treatment |
| Masking | None (participants and researchers aware of assignment) |
| Enrollment | 60 participants (30 per arm) |
Intervention Arms
Arm 1: Power Resistance Training (Active Comparator)
Participants in this arm receive traditional high-speed power resistance training:
- Frequency: 2 sessions per week
- Duration: 12 weeks (minimum 24 sessions)
- Session Length: 45 minutes
- Protocol: 3 sets of 8 repetitions per exercise
- Rest: 1 minute between sets
- Exercises: 6 upper-body + 5 lower-body exercises
- Focus: High-velocity concentric movements at moderate loads
The power training approach emphasizes rapid force production through quick muscle contractions, targeting the velocity component of force generation that is particularly affected in Parkinson's disease[@fragkiadaki2023].
Arm 2: Periodized Resistance Training (Experimental)
Participants in this arm undergo a structured block periodization program:
- Frequency: 2 sessions per week
- Duration: 12 weeks (minimum 24 sessions)
- Session Length: 45 minutes
- Protocol: Phased approach with distinct training blocks
- Rest: 1 minute between sets
- Exercises: 6 upper-body + 5 lower-body exercises
The periodization protocol follows a three-phase block model:
| Phase | Duration | Focus | Intensity |
|-------|----------|-------|-----------|
| Hypertrophy | Weeks 1-3 | Muscle growth, metabolic stress | 60-70% 1RM, 12-15 reps |
| Strength | Weeks 4-9 | Force development | 75-85% 1RM, 6-10 reps |
| Power | Weeks 10-12 | Velocity training | 50-70% 1RM, 3-6 reps |
This systematic cycling allows different physiological adaptations to be targeted sequentially, potentially optimizing overall training efficiency[@hemmelmann].
Eligibility Criteria
Inclusion Criteria
Parkinson's Disease Diagnosis: Confirmed PD with Hoehn & Yahr Stages 1-3
Mobility: Able to walk 50 meters unassisted
Communication: Able to understand and communicate in English
Age: 50-85 yearsExclusion Criteria
Cardiovascular: Uncontrolled cardiovascular disease preventing exercise participation
Neuromuscular: Other neuromuscular disorders precluding training
Inflammatory/Autoimmune: Systemic inflammatory or autoimmune conditions (e.g., rheumatoid arthritis)
Orthopedic: Unresolved injury or surgery to upper or lower limbs preventing weight trainingRationale for Eligibility Criteria
The inclusion of Hoehn & Yahr stages 1-3 ensures participants can safely perform resistance exercises while representing the population most likely to benefit from exercise interventions. The exclusion criteria protect vulnerable individuals from exercise-related adverse events while maintaining external validity[@schoot2022].
Outcome Measures
Primary Endpoints
1. Change in 1-Repetition Maximum (1RM)
Measure: Maximum load that can be lifted in one repetition
Testing Protocol:
- Tested in leg press and chest press
- Progressive loading across 5-7 testing attempts
- Highest load successfully moved through full range of motion recorded
- Unit: kilograms
Timepoints: Baseline, 12 weeks
Significance: 1RM is the gold standard for measuring muscle strength and provides direct insight into force-generating capacity. Reductions in 1RM are associated with functional decline in PD, while improvements predict better outcomes[@bloem2023].
2. Change in Power Output (Watts)
Measure: Power produced at various loads
Testing Protocol:
- Tested at 20%, 40%, 60%, 80%, and 90% of 1RM
- Both chest press and leg press assessed
- Power = Force × Velocity
- Unit: Watts
Timepoints: Baseline, 12 weeks
Significance: Power (the ability to produce force rapidly) is more strongly associated with functional mobility than strength alone. PD particularly affects power generation, making this a clinically meaningful endpoint[@fragkiadaki2023].
Secondary Endpoints
3. Ten-Meter Walk Test
Measure: Gait velocity
Protocol:
- Walk 10 meters at usual and fast pace
- Timed from 2-meter to 8-meter mark (6 meters)
- Two trials at each speed, averaged
- Unit: meters per second
Clinical Significance: Gait speed is a powerful predictor of fall risk, institutionalization, and mortality in PD. Improvements of 0.10 m/s are considered clinically meaningful.
4. Five Times Sit-to-Stand Test
Measure: Functional lower body strength
Protocol:
- Sit with arms folded across chest, back against chair
- Stand up and sit down 5 times as quickly as possible
- One practice trial, two test trials
- Unit: seconds
Clinical Significance: This test predicts functional independence and fall risk. It specifically assesses the lower limb strength needed for daily activities like rising from a chair.
5. Seated Medicine Ball Throw
Measure: Upper body power
Protocol:
- Seated in armless chair, back against chair back
- Hold 6-pound medicine ball against chest
- Throw at 45° angle as far as possible
- Three trials each at varying weights
- Unit: centimeters
Clinical Significance: Assesses functional upper body power important for reaching and daily activities.
6. Timed Up-and-Go (TUG) Test
Measure: Dynamic mobility and balance
Protocol:
- Stand up from seated position
- Walk around cone 3 meters away
- Return to seated position as quickly as possible
- Unit: seconds
Clinical Significance: The TUG is a validated, reliable measure of functional mobility in PD. Times >13.5 seconds indicate increased fall risk.
Scientific Background
Periodization in Rehabilitation
Periodization has been a cornerstone of athletic training for decades, but its application to rehabilitation populations is emerging. The principle of systematic training variation allows:
Targeted Adaptation: Different phases target specific physiological systems
Overreaching: Strategic fatigue followed by recovery enhances adaptation
Injury Prevention: Varied loads reduce repetitive stress
Motivation: Novel stimuli maintain engagementBlock Periodization Specifics
Block periodization, as used in this trial, organizes training into concentrated phases:
Phase 1: Hypertrophy (Weeks 1-3)
- Higher volume, moderate intensity
- Aims to increase muscle cross-sectional area
- Improves tendon stiffness
- Metabolic stress stimulates growth signaling
Phase 2: Strength (Weeks 4-9)
- Moderate volume, high intensity
- Aims to increase maximal force production
- Neural adaptations dominate
- Improves motor unit recruitment
Phase 3: Power (Weeks 10-12)
- Low volume, variable intensity
- Aims to convert strength into explosive power
- Emphasizes velocity of movement
- Integrates previous phases' gains
Power Training in Parkinson's Disease
Power training specifically targets the velocity component of movement that is disproportionately affected in PD:
Why Power Matters in PD
Bradykinesia: Reduced movement velocity is a cardinal PD symptom
Functional Impact: Power predicts fall risk better than strength
Daily Activities: Many ADLs require rapid force generation (rising from chair, catching oneself)Evidence for Power Training
Studies show power training improves:
- Gait speed and stability
- Chair rise performance
- Balance confidence
- Quality of life
The mechanism involves both neural adaptations (faster motor unit recruitment) and muscle-specific changes (improved fiber type recruitment)[@ruder2023].
Neurobiological Mechanisms
Both training approaches likely benefit PD through multiple pathways:
Neurotrophic Factor Release
Exercise increases brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), and insulin-like growth factor (IGF-1). These factors:
- Protect remaining dopaminergic neurons
- Promote neurogenesis and synaptic plasticity
- May reduce alpha-synuclein pathology
Neuroinflammation Reduction
Exercise modulates microglial activation and reduces pro-inflammatory cytokines (IL-6, TNF-α). Chronic neuroinflammation drives PD progression, making this an important disease-modifying mechanism.
Motor Circuit Plasticity
Exercise enhances functional connectivity in motor networks:
- Improved basal ganglia output
- Enhanced cortical motor control
- Compensatory pathways develop
Clinical Significance
Exercise as Disease Modification in PD
This trial contributes to growing evidence that exercise may modify PD progression beyond symptomatic management:
Neuroprotection: Exercise may protect remaining neurons through increased neurotrophic support
Compensation: Enhanced cortical control can compensate for basal ganglia dysfunction
Synaptic Plasticity: Exercise promotes long-term potentiation in striatumPeriodization Advantages
If block periodization proves superior, it would provide:
- More efficient training protocols
- Systematic approach to progression
- Clear framework for clinicians
Practical Implications
For clinicians prescribing exercise in PD:
| Consideration | Power Training | Periodization |
|---------------|----------------|---------------|
| Simplicity | Simple to implement | Requires phase transitions |
| Progression | Gradual load increase | Distinct phase shifts |
|Adaptation | Single pathway | Multiple targeted pathways |
| Monitoring | Load-based | Phase-specific metrics |
Study Location
Recruitment Site
Laboratory of Neuromuscular Research and Active Aging
- Institution: University of Miami
- City: Coral Gables, Florida
- Country: United States
- ZIP: 33147
| Role | Name | Contact |
|------|------|---------|
| Primary Contact | Caleb P Calaway, BS | cpc79@miami.edu |
| Principal Investigator | Joseph F. Signorile, PhD | jsignorile@miami.edu |
| Phone | — | 305-284-3105 |
Recruitment Status
Currently Recruiting: The trial is actively enrolling participants meeting eligibility criteria.
Expected Outcomes
Based on the study design and existing evidence, this trial will provide valuable data on:
Comparative Effectiveness: Direct head-to-head comparison of two training paradigms
Mechanism Insights: Understanding which physiological systems benefit most from each approach
Clinical Guidance: Evidence-based recommendations for exercise prescription in PDHypotheses
Primary Hypothesis: Block periodization training will produce greater improvements in power output compared to traditional power training, while producing equivalent improvements in strength.
Secondary Hypotheses:
- Periodization may show advantages in functional measures (TUG, sit-to-stand)
- Both groups will show improvements in gait velocity
- Adherence may be higher in the periodization group due to varied stimuli
Limitations and Considerations
Study Limitations
Sample Size: 60 participants may limit generalizability to all PD populations
Single Center: Results from one site may not generalize to other settings
Blinding: Absence of masking could influence participant expectations
Duration: 12-week intervention may not capture long-term effectsPD-Specific Considerations
Medication Timing: "ON/OFF" fluctuations may affect performance
Disease Heterogeneity: Wide range of symptoms within Hoehn-Yahr 1-3
Comorbidities: Excluded conditions may affect real-world applicability
- [Parkinson's Disease](/diseases/parkinsons-disease)
- [Exercise and Neurodegeneration](/mechanisms/exercise-neuroprotection-pd)
- [Resistance Training for PD](/clinical-trials/nct07165106)
- [Movement Disorders](/diseases/movement-disorders)
- [Physical Therapy for PD](/rehabilitation/physical-therapy-parkinsons)
- [Sarcopenia in Parkinson's Disease](/mechanisms/sarcopenia-neurodegeneration)
External Links
- [ClinicalTrials.gov Record](https://clinicaltrials.gov/study/NCT07141849)
- [University of Miami](https://www.miami.edu)
- [Parkinson's Foundation Exercise Resources](https://www.parkinson.org/life-with-pd/exercise)
References
[Signorile JF, Principal Investigator, University of Miami (2025)](https://www.miami.edu)
[Hemmelmann et al., Comparative analysis of periodization models in older adults (2024)](https://doi.org/10.1186/s12877-024-04789-5)
[Fragkiadaki et al., Resistance training in neurodegenerative diseases (2023)](https://doi.org/10.3390/geriatrics8010008)
[Schoot et al., Exercise therapy for Parkinson's disease: a systematic review (2022)](https://doi.org/10.1177/02692155221087000)
[Bloem et al., Parkinson's disease exercise interventions (2023)](https://doi.org/10.1016/j.parkreldis.2023.01.012)
[Ruder et al., Exercise-induced neuroplasticity in Parkinson's disease (2023)](https://doi.org/10.1002/mdc3.13567)