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Periodization and Parkinson's Disease (NCT07141849)

Overview

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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"].

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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 years

Exclusion 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 training

Rationale 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 engagement

Block 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 striatum

Periodization 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

Contact Information

| 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 PD

Hypotheses

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 effects

PD-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)

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clinical-trials-periodization-training-pd-nct07141849

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📊 Evidence Profile

Evidence Balance

+0%

Certainty

20%

Debates

0

Incoming

4

Outgoing

11

0 supporting 0 contradicting 0 neutral

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📗 Cite This Artifact

periodization-training-pd-nct07141849

Periodization and Parkinson's Disease (NCT07141849)

Overview

Periodization and Parkinson's Disease (NCT07141849)

Overview

Trial Details

Conditions Studied

Study Design

Trial Architecture

Intervention Arms

Arm 1: Power Resistance Training (Active Comparator)

Arm 2: Periodized Resistance Training (Experimental)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Rationale for Eligibility Criteria

Outcome Measures

Primary Endpoints

1. Change in 1-Repetition Maximum (1RM)

2. Change in Power Output (Watts)

Secondary Endpoints

3. Ten-Meter Walk Test

4. Five Times Sit-to-Stand Test

5. Seated Medicine Ball Throw

6. Timed Up-and-Go (TUG) Test

Scientific Background

Periodization in Rehabilitation

Block Periodization Specifics

Power Training in Parkinson's Disease

Why Power Matters in PD

Evidence for Power Training

Neurobiological Mechanisms

Neurotrophic Factor Release

Neuroinflammation Reduction

Motor Circuit Plasticity

Clinical Significance

Exercise as Disease Modification in PD

Periodization Advantages

Practical Implications

Study Location

Recruitment Site

Contact Information

Recruitment Status

Expected Outcomes

Hypotheses

Limitations and Considerations

Study Limitations

PD-Specific Considerations

Related Resources

External Links

References

💬 Discussion