NCT07172698

Brief 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. 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, and G2 - multicomponent training with an emphasis on muscle power. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

July 28, 2025

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

  • Mobility of the posterior chain of the trunk and lower limbs

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

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

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

  • Rigidity of the leg extensor muscles assessed by ultrasound elastography

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

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

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

  • Functional capacity through the CounterMovement Jump - CMJ

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

  • +2 more secondary outcomes

Study Arms (2)

G1 - traditional multicomponent training

EXPERIMENTAL

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

Other: traditional multicomponent training

G2 - multicomponent training with an emphasis on muscle power

EXPERIMENTAL

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.

Other: multicomponent training with an emphasis on muscle power

Interventions

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

G1 - traditional multicomponent training

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.

G2 - multicomponent training with an emphasis on muscle power

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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;
  • Previous spinal surgeries;
  • Tumors or infection of the spinal column;
  • Inflammatory diseases of the spinal column;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

July 28, 2025

First Posted

September 15, 2025

Study Start

November 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations