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

NCT ID: NCT07095400

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-07
• Study Completion Date: 2027-06-30

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.

Detailed Description

Parkinson's Disease (PD) is a multifaceted neurodegenerative condition marked by the gradual degeneration of dopaminergic neurons, causing a spectrum of motor impairments-such as tremor, rigidity, and bradykinesia-and non-motor challenges, including anxiety, depression, and cognitive decline. Previous research indicates that strength training can positively impact both the motor abilities and certain biochemical parameters related to oxidative stress and neurodegeneration in individuals with PD.

This study is designed as a quasi-experimental, prospective, longitudinal investigation involving patients recruited from a specialized care center for PD. Over the course of 12 weeks, participants will engage in a strength training program consisting of 24 sessions (twice weekly). The primary objective is to assess changes in functional outcomes and biochemical markers, with secondary aims addressing balance, gait, psychological status, cognitive function, and overall quality of life.

Functional assessments will include tests such as the Timed Up and Go Test, Berg Balance Scale, 10-Meter Walk Test, and the 30-Second Sit-to-Stand Test. Cognitive and emotional functions will be evaluated using the Mini-Mental State Examination, GAD-7, and PHQ-9 questionnaires, while quality of life will be measured with the PDQ-39 questionnaire. Biochemical analyses will focus on markers of oxidative stress-Malondialdehyde (MDA), 8-OHdG, Total Antioxidant Capacity (TAC)-and neurodegeneration via neurofilament light chain (NfL) levels.

Through this comprehensive approach, the study seeks to contribute valuable evidence on the benefits of strength training in PD and aims to optimize therapeutic protocols that enhance the quality of life and functional independence of affected patients.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Strength training group

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.

Group Type: EXPERIMENTAL

strength training

Intervention Type: 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.

Interventions

strength training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Villanueva

OTHER

Sponsor Role: lead

Responsible Party

Noelia Diaz Lopez

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noelia Díaz López, Doctor

Role: STUDY_DIRECTOR

Universidad Villanueva

Locations

Universidad Villanueva

Madrid, Madrid, Spain

Countries

Spain

Central Contacts

Selena Marcos Antón, Doctor

Role: CONTACT

selena.marcos@villanueva.edu

+34 692824096

Facility Contacts

Selena Marcos Antón, Doctor

Role: primary

selena.marcos@villanueva.edu

+34 692824096

Other Identifiers

240320252802025

Identifier Type: -

Identifier Source: org_study_id