Parkinson DiseasePOWER-PDNCT07095400
Evaluation of Functional and Biochemical Effectiveness of a Strength Training Protocol in Parkinson's Disease
A study testing strength training in people with Parkinson Disease, run by Universidad Villanueva at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 7 Sep 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad Villanueva
Madrid, Madrid, 28034
Selena Marcos Antón, Doctor, +34 692824096, selena.marcos@villanueva.edu
Selena Marcos Antón, Doctor
About this study
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.
Read the 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
- Being tested
- strength training
- Keywords
- strength training, physical exercise, oxidative stress, neurofilament light chain, parkinson's disease
- Medical subject headings
- Parkinson Disease, Motor Activity, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strength trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start7 Sep 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Villanueva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia Diaz Lopez, Universidad Villanueva
- Investigators
- Noelia Díaz López, Doctor, Study director, Universidad Villanueva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095400
- Sponsor's protocol ID
- 240320252802025
- Acronym
- POWER-PD
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional and Biochemical Effectiveness of a Strength Training Protocol in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07095400
- Acronym / sponsor ID
- POWER-PD / 240320252802025
- Conditions
- Parkinson Disease
- Keywords
- strength training, physical exercise, oxidative stress, neurofilament light chain, parkinson's disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Universidad VillanuevaUniversity, hospital or other
- Study start
- 7 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strength training group | Experimental | Other: strength trainingAn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strength trainingAn 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 group |
Primary outcome
Timed Up and Go Test
Time frame: 12 weeks
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.
Berg Balance Scale
Time frame: 12 weeks
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.
10 meter walk test
Time frame: 12 weeks
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.
30 second sit to stand test
Time frame: 12 weeks
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.
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: 12 weeks
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.
Mini-Mental State Examination
Time frame: 12 weeks
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.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 weeks
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.
Malondialdehyde (MDA)
Time frame: 12 weeks
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.
8-Hydroxy-2'-deoxyguanosine (8-OHdG)
Time frame: 12 weeks
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.
Total Antioxidant Capacity (TAC)
Time frame: 12 weeks
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.
Neurofilament Light Chain (NfL)
Time frame: 12 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noelia Díaz López, Doctor study director
Universidad Villanueva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strength training in people with Parkinson Disease, run by Universidad Villanueva at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selena Marcos Antón, Doctor (+34 692824096, selena.marcos@villanueva.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (time frame: 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.