Evaluation of Functional and Biochemical Effectiveness of a Strength Training Protocol in Parkinson's Disease

NCT07095400 | Not Yet Recruiting

• 1 other identifier: 240320252802025
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's Disease (PD) is a complex neurodegenerative disorder characterized by the progressive loss of dopaminergic neurons, which results in a range of motor symptoms such as tremor, rigidity, and bradykinesia, as well as non-motor symptoms including anxiety, depression, and cognitive decline. Strength training has emerged as a promising intervention to improve motor function and influence biochemical markers associated with oxidative stress and neurodegeneration. This study aims to evaluate the effectiveness of a structured strength training protocol over 12 weeks in improving both functional and biochemical outcomes in patients with PD.

Conditions

Parkinson Disease

Keywords

strength training; physical exercise; oxidative stress; neurofilament light chain; parkinson's disease

Outcome Measures

Primary Outcomes (11)

• Timed Up and Go Test

  Test developed to evaluate balance and functional mobility to determine the risk of falling. The test consists of timing how long it takes the subject to perform the action of standing up from a chair, walking 3 meters in a straight line, turning around, and sitting back down in the chair. An increase in the time taken to complete the test indicates worse outcomes.

  12 weeks

• Berg Balance Scale

  Scale developed to evaluate balance and postural control. The scale consists of 14 items with Likert-type responses ranging from 0 to 4, where 0 represents the lowest level of function and 4 represents the highest level of function. Higher values indicate better balance control.

  12 weeks

• 10 meter walk test

  Instrument used to evaluate gait speed in meters per second. The test consists of timing how long it takes the subject to cover a 10-meter straight path (to avoid acceleration-deceleration effects, 2 meters are added at the beginning and end of the path). An increase in the time taken to complete the test indicates worse outcomes.

  12 weeks

• 30 second sit to stand test

  Instrument used to evaluate the strength and endurance of the lower limbs. The test is performed with a 43 cm chair without armrests; the number of squats the subject is able to perform in 30 seconds is counted. The higher the number of squats performed, the better the test results.

  12 weeks

• Parkinson's Disease Questionnaire (PDQ-39)

  It is an instrument that evaluates the quality of life in patients with Parkinson's disease. It includes 8 areas: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Higher scores on the PDQ-39-SV scale indicate worse outcomes.

  12 weeks

• Mini-Mental State Examination

  It is a widely used screening tool for assessing cognitive function. It is commonly employed to detect cognitive impairment and monitor changes over time in conditions such as dementia or following neurological events like stroke or traumatic brain injury. The total score ranges from 0 to 30. A higher score indicates better cognitive performance and less impairment.

  12 weeks

• Patient Health Questionnaire-9 (PHQ-9)

  It is an instrument that assesses the severity of depressive symptoms. The total score range from 0 to 27. Each of the nine items is rated on a scale from 0 to 3, resulting in a minimum score of 0 (indicating no depressive symptoms) and a maximum score of 27 (indicating severe depression). Higher scores indicate greater severity of depressive symptoms.

  12 weeks

• Malondialdehyde (MDA)

  MDA, measured in nanomoles per milliliter (nmol/mL), is a byproduct of lipid peroxidation and one of the most widely studied markers of oxidative tissue damage, particularly during exercise. Higher MDA levels indicate greater lipid oxidative damage, suggesting a more harmful oxidative environment. MDA levels will be assessed using ELISA according to the manufacturer's instructions.

  12 weeks

• 8-Hydroxy-2'-deoxyguanosine (8-OHdG)

  8-OHdG is a marker of oxidative damage to DNA, typically measured in nanograms per milliliter (ng/mL) or nanomoles per liter (nmol/L). Elevated 8-OHdG levels reflect increased DNA oxidation, which is associated with cellular aging and neurodegenerative processes. Quantification will be performed using ELISA, following the manufacturer's protocol.

  12 weeks

• Total Antioxidant Capacity (TAC)

  TAC reflects the overall antioxidant defense and is generally expressed in millimoles of Trolox equivalents per liter (mmol Trolox/L). Higher TAC values indicate stronger antioxidant capacity, suggesting a more favorable redox balance. TAC will be analyzed using ELISA in accordance with the manufacturer's instructions.

  12 weeks

• Neurofilament Light Chain (NfL)

  NfL, measured in picograms per milliliter (pg/mL), is a well-established biomarker of neuroaxonal damage and neurodegeneration, released into extracellular fluids following axonal injury. Higher NfL levels indicate greater neuroaxonal damage, and thus worse neurological status. Levels of NfL will be determined using ELISA, following the manufacturer's recommendations.

  12 weeks

Study Arms (1)

Strength training group

EXPERIMENTAL

An intervention based on the application of a strength training protocol for multi-joint and single-joint muscles will be implemented, performed with a slow-moderate execution speed. This intervention will be carried out over 12 weeks, with a total of 24 sessions (2 sessions per week), each lasting 45 minutes. In all of these sessions, free weights will be used, performing three sets at 60-80% of 1RM for 8-12 repetitions. The exercise protocol will include: * Squats * Deadlifts * Rows * Bicep curls * Bench press * Shoulder press Each set will be performed to muscular failure, progressing in the number of repetitions (from 8 to 12). Once 12 repetitions are reached, the load volume will be increased by adding 5% to the weight.

Other: strength training

Interventions

strength training OTHER

An intervention based on the application of a strength training protocol for multi-joint and single-joint muscles will be implemented, performed with a slow-moderate execution speed. This intervention will be carried out over 12 weeks, with a total of 24 sessions (2 sessions per week), each lasting 45 minutes. In all of these sessions, free weights will be used, performing three sets at 60-80% of 1RM for 8-12 repetitions. The exercise protocol will include: * Squats * Deadlifts * Rows * Bicep curls * Bench press * Shoulder press Each set will be performed to muscular failure, progressing in the number of repetitions (from 8 to 12). Once 12 repetitions are reached, the load volume will be increased by adding 5% to the weight.

Strength training group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with PD who meet the modified diagnostic criteria of the UK Brain Bank.
• Patients in stage II or III of the Hoehn and Yahr Scale.
• A score greater than 60% on the Schwab and England Functional Scale.
• Patients whose motor response to pharmacological treatment is stable or slightly fluctuating and who are not receiving any specific strength training rehabilitation treatment at the time of the study.

You may not qualify if:

• Diagnosis of a condition other than PD.
• Significant comorbidities and/or severe systemic diseases that would prevent participation in exercise (e.g., recent surgery, cardiac instability, anemia, hepatosis, pulmonary disorders, chronic renal failure, or severe mental disorders).
• Inability to actively understand instructions and cooperate in the tasks given, based on a score \<24 on the Mini-Mental State Examination (MMSE).
• Refusal to participate in the study.
• Stages I, IV, or V of the Hoehn and Yahr Scale.

Sponsors & Collaborators

• Universidad Villanueva: lead

Study Sites (1)

Universidad Villanueva

Madrid, Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Charcot-Marie-Tooth disease, Type 1F

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Noelia Díaz López, Doctor

  Universidad Villanueva

  STUDY DIRECTOR

Central Study Contacts

Selena Marcos Antón, Doctor

CONTACT

+34 692824096; selena.marcos@villanueva.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 31, 2025
• Study Start: September 7, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

ES (1)