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Parkinson Disease (PD)NCT07172698

Effects of a Multicomponent Protocol With Emphasis on Muscle Power Training on Bradykinesia in Individuals With Parkinson's Disease

A study testing multicomponent training with an emphasis on muscle power and traditional multicomponent training in people with Parkinson Disease (PD), run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Parkinson's disease (PD) is a chronic progressive neurological disorder that involves both motor and non-motor symptoms, culminating in functional decline and disability. One of the main symptoms of PD is bradykinesia and its deleterious effect on functionality. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Parkinson Disease (PD)
What is being tested?
multicomponent training with an emphasis on muscle power and traditional multicomponent training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteBrazil
Study dates
1 Nov 2025to 1 Dec 2026
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 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be included in the research, individuals must:
  • be Diagnosed with Parkinson's disease and classified as 1 to 3 on the Hoehn and Yahr Scale;
  • Present rigid akinetic PD;
  • Be Aged between 50 and 85 years;
  • Achieve a minimum score of 21 points on the Montreal Cognitive Assessment (MoCa);
  • Sign the Informed Consent Form (ICF)

Who cannot join

  • Individuals will be excluded from this study if they present:
  • Previous associated neurological diseases;
  • Vestibular system disorders;
  • Change in the pattern of levodopa use during the study;
  • Severe heart disease;
  • Uncontrolled arterial hypertension;
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  • Previous spinal surgeries;
  • Tumors or infection of the spinal column;
  • Inflammatory diseases of the spinal column;

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Federal University of Health Sciences of Porto Alegre

    Porto Alegre, Rio Grande do Sul

Other trials in Brazil

About this study

Parkinson's disease (PD) is a chronic progressive neurological disorder that involves both motor and non-motor symptoms, culminating in functional decline and disability. One of the main symptoms of PD is bradykinesia and its deleterious effect on functionality. Muscle weakness has also been reported as an important symptom of PD, and muscle power may be even more affected and related to these symptoms. Typical conventional physical therapy treatment includes mobility exercises, strength training, gait training, and balance training, and it presents numerous benefits associated with the reduction of motor symptoms of PD. Physical therapy with power training has also been studied as an alternative to improve the ability to perform activities of daily living in other populations. However, the literature that includes power training in physiotherapeutic approaches for people with PD is scarce. Power training may minimize the problems arising from changes in motor function in older adults with PD; however, there is still a lack of evidence using this modality in the different subtypes of the disease. Knowing that motor function is associated with functional capacity and disease severity, physical therapy becomes an important treatment resource with exercises to improve muscle power. Therefore, the objective of this study is to investigate the effect of a multicomponent protocol with an emphasis on muscle power training concerning bradykinesia in individuals with rigid-akinetic type PD. A Randomized Clinical Trial will be conducted, in which individuals diagnosed with Parkinson's disease, rigid-akinetic type, classified from 1 to 3 on the Hoehn and Yahr Scale, aged between 50 and 85 years, and who sign the Informed Consent Form will participate. The individuals will be randomized into two treatment groups: G1 - traditional multicomponent training, G2 - multicomponent training with an emphasis on muscle power and G3 - control group. Assessments will be conducted at four time points for all participants: before (T0), during (T1 - 6 weeks), immediately after intervention (T3 - 12 weeks), and follow-up (T4 - 16 weeks). The assessments will consist of the analysis of: 1) motor function through the adapted Unified Parkinson's Disease Rating Scale (UPDRS III) (bradykinesia as the primary outcome); 2) mobility of the posterior chain of the trunk and lower limbs using the Wells Bench; 3) body composition by Dual-Energy X-ray Absorptiometry (DXA); 4) rigidity of the leg extensor muscles assessed by ultrasound elastography; 5) muscle power of knee extensors using a linear potentiometer (Peak Power, CEFISE); 6) functional capacity through the CounterMovement Jump - CMJ and the Sit-to-Stand Five Times Test (TSLCV); and 7) postural assessment using the NeuroPostureApp. Treatment sessions will occur twice a week for 12 weeks, lasting 60 minutes each, totaling 24 sessions for each intervention. Group 1 will perform an exercise protocol that includes warm-up, mobility, muscle strength, and flexibility. Group 2 will perform the same exercise protocol, with the caveat that, whenever feasible, exercises will be executed in the muscle power modality (at the highest possible speed). This latter training is characterized by a lower number of repetitions and a higher movement speed, guided by the therapists assisting. The progression of muscle power exercises will occur at 35%, 40%, 45%, 50%, 55%, and 60% of 1RM over the 12 weeks, distributed in 2 sets of 6 to 8 repetitions, with rest times of 60 to 120 seconds. Group 3 will undergo a protocol similar to traditional physiotherapy, without 1RM-based intensity control, periodization, or systematic load progression as applied in the other groups. Load and exercise progression will be adjusted subjectively based on the physiotherapist's clinical judgment and the participant's perceived exertion. Assessments will occur at the same time points (T0, T1, T2, and T3), and the same exercises will be performed, but intensity and exercise difficulty progression will be controlled subjectively.

Being tested
multicomponent training with an emphasis on muscle power, traditional multicomponent training, control group
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multicomponent training with an emphasis on muscle powerOther

    Group 2 will perform the same exercise protocol, with the caveat that, whenever feasible, exercises will be executed in the muscle power modality (at the highest possible speed). This latter training is characterized by a lower number of repetitions and a higher movement speed, guided by the therapists assisting. The progression of muscle power exercises will occur at 35%, 40%, 45%, 50%, 55%, and 60% of 1RM over the 12 weeks, distributed in 2 sets of 6 to 8 repetitions, with rest times of 60 to 120 seconds.

  • traditional multicomponent trainingOther

    Group 1 will perform an exercise protocol that includes warm-up, mobility, muscle strength, and flexibility

  • control groupOther

    Group 3 will undergo a protocol similar to traditional physiotherapy. In this group, training intensity will not be controlled based on the one-repetition maximum (1RM) test, nor will periodization strategies or systematic load progression be applied, as performed in the other intervention groups. Load adjustments and exercise progression will be conducted subjectively, considering both the clinical judgment of the physiotherapist and the participant's perceived exertion. Assessment time points will be identical to those adopted in the other groups and will be conducted at T0, T1, T2, and T3. The exercises performed will be the same as those used in the other groups; however, exercise intensity control and progression of exercise difficulty will be implemented subjectively.

Study groups in NCT07172698
Study groupRoleWhat they receive
G1 - traditional multicomponent trainingExperimentalGroup 1 will perform an exercise protocol that includes warm-up, mobility, muscle strength, and flexibility
Receives: Other: traditional multicomponent training
G2 - multicomponent training with an emphasis on muscle powerExperimentalGroup 2 will perform the same exercise protocol, with the caveat that, whenever feasible, exercises will be executed in the muscle power modality (at the highest possible speed). This latter training is characterized by a lower number of repetitions and a higher movement speed, guided by the therapists assisting. The progression of muscle power exercises will occur at 35%, 40%, 45%, 50%, 55%, and 60% of 1RM over the 12 weeks, distributed in 2 sets of 6 to 8 repetitions, with rest times of 60 to 120 seconds.
Receives: Other: multicomponent training with an emphasis on muscle power
G3 - control groupActive comparatorGroup 3 will undergo a protocol similar to traditional physiotherapy. In this group, training intensity will not be controlled based on the one-repetition maximum (1RM) test, nor will periodization strategies or systematic load progression be applied, as performed in the other intervention groups. Load adjustments and exercise progression will be conducted subjectively, considering both the clinical judgment of the physiotherapist and the participant's perceived exertion. The exercises performed will be the same as those used in the other groups; however, exercise intensity control and progression of exercise difficulty will be implemented subjectively.
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bradykinesia

    The objective of this study is to investigate the effect of a multicomponent protocol with an emphasis on muscle power training concerning bradykinesia in individuals with rigid-akinetic type PD. This outcome will be measured using the UPDRS (Unified Parkinson's Disease Rating Scale) Part III.

    Measured: Baseline, 6 weeks, end of intervention (12 weeks) and follow-up (16weeks)

Secondary outcomes (7)
  1. Mobility of the posterior chain of the trunk and lower limbs

    Sit and Reach (SA) Test on the Wells Bench This tool allows the assessment of the amplitude and flexibility of the back of the trunk and lower limbs. To perform the test, the Wells bench is used, where individuals are instructed to sit with their feet in full contact with the front of the bench and their lower limbs with their hips flexed and their knees extended. The subjects are instructed to perform a trunk flexion together with a forced exhalation and to move the bench scale as far as they can. This procedure is performed three times and immediately noted by the evaluator; the value obtained in each attempt is expressed in centimeters, and the best one is selected.

    Measured: Baseline, 6 weeks, end of intervention (12 weeks) and follow-up (16weeks)

  2. Body composition by Dual-Energy X-ray Absorptiometry (DXA)

    Dual-energy X-ray absorptiometry (DXA) is a method used to assess body composition. DXA is one of the most accurate and consistent techniques for evaluating body composition, particularly in quantifying fat mass, lean mass, and bone mineral density.

    The composition of the dominant lower limb thigh of the participant will be estimated using dual-energy X-ray absorptiometry with a Lunar Prodigy Advance device (GE Healthcare, Chicago, IL, USA). According to the manufacturer's recommendations, prior to scanning, participants will be asked to remove all removable metal-containing objects (e.g., jewelry, glasses, clothing with buttons or zippers). Scans will be performed with participants lying in a supine position along the longitudinal axis of the scanner table's centerline. The feet will be tied together to immobilize the legs, while the hands will be placed in a prone position within the scanning region. All assessments will be conducted by the same examiner. DXA

    Measured: Baseline, 6 weeks, end of intervention (12 weeks) and follow-up (16weeks)

  3. Rigidity of the leg extensor muscles assessed by ultrasound elastography

    To analyze stiffness by elastography, an ultrasound device (Nemio XG, Toshiba, Japan), tape measure, dermographic pen, and water-soluble gel will be used.

    Muscle thickness (MT, mm) and subcutaneous fat thickness (SFT, mm) of the vastus lateralis, rectus femoris, and vastus intermedius muscles of the right limb will be measured using B-mode imaging using an ultrasound device (Nemio XG, Toshiba, Japan) with a 7.5 MHz linear probe (38 mm depth, 90 dB gain).

    Before imaging begins, to allow for the distribution of body fluids, participants will lie supine for 5 minutes with their lower limbs extended and relaxed, and must remain in this position throughout the assessment. A water-soluble gel, which promotes acoustic contact without applying pressure to the skin, will be applied to the assessment site, and the transducer will be positioned perpendicular to the assessed muscles.

    Measured: Baseline, 6 weeks, end of intervention (12 weeks) and follow-up (16weeks)

  4. Muscle power of knee extensors using a linear potentiometer (Peak Power, CEFISE)

    The linear potentiometer (Peak Power, CEFISE) consists of an electronic system interfaced to software that measures the displacement speed of any body within a range of up to 2.5 meters. The speed is measured by a precision stopwatch connected to a wire that can be attached to the dumbbell or weight column of the equipment. The use of a linear encoder to assess power has been proven to be safe in people with Parkinson's disease. Muscle power will be assessed on the KONNEN GYM® knee machine.

    Measured: Baseline, 6 weeks, end of intervention (12 weeks) and follow-up (16weeks)

  5. Functional capacity through the CounterMovement Jump - CMJ

    The analysis of the vertical jump allows the collection of several metrics (flight time, exit speed and joint angle). Based on these measurements, it is possible to estimate other significant values such as muscle power of the lower limbs and jump height. A verification of the complete movement can be performed (separation of each stage and the influence of these stages on the performance of the individuals) or, in a more simplified way, only the height of the jump can be considered. This estimate is generally made based on the flight time and assuming constant acceleration of the individual's center of mass. To obtain these metrics, we will use a force platform (Cefise - Jump, System Pro, software version 1.0, Brazil).

    The signal will be captured at a frequency of 1000 Hz and the force platform will be calibrated before all tests according to the manufacturer's instructions.

    Measured: Baseline, 6 weeks, end of intervention (12 weeks) and follow-up (16weeks)

  6. Sit-to-Stand Five Times Test

    The TSLCV can be used to assess functional mobility, including risk of falling, balance and measurement of lower limb strength in people with Parkinson's.

    The individual begins the test sitting in a chair without arms and is instructed to stand with arms crossed over the chest; with full extension of the hips and knees, returning to a sitting position with the back supported by the vertical back of the chair. It should be repeated 5 times sequentially and without interruption; recording the total time taken to perform the test. A risk of falling is suggested when the individual performs the test for more than 16 seconds.

    Measured: Baseline, 6 weeks, end of intervention (12 weeks) and follow-up (16weeks)

  7. Postural assessment using the NeuroPostureApp

    The postural assessment will be performed using the NeuroPostureApp application, which is available free of charge in full (http://www.neuroimaging.uni-kiel.de/NeuroPostureApp). This instrument allows you to use a photo in a lateral view to assess camptocormia using the reference points (lateral malleolus, L5 and C7).

    Measured: Baseline, 6 weeks, end of intervention (12 weeks) and follow-up (16weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start1 Nov 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07172698
Sponsor's protocol ID
FUHSPortoAlegre_Minotto_Amado
Status last verified
Aug 2026
First submitted
28 Jul 2025
Last updated
31 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing multicomponent training with an emphasis on muscle power and traditional multicomponent training in people with Parkinson Disease (PD), run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. 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 Brazil. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bradykinesia (time frame: Baseline, 6 weeks, end of intervention (12 weeks) and follow-up (16weeks)). 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 Aug 2026.

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