NCT05152706

Brief Summary

The aim of the present study was to assess the effects of a combined therapy of aerobic exercise and transcranial photobiomodulation upon the cardinal motor sympomts of Parkinson´s disease of a group of Parkinson´s disease patients. It was hypothesized that aerobic exercise and transcranial photobiomodulation would yield significant benefits in the cardinal motor sympomts of the illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable parkinson-disease

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

Study Start

First participant enrolled

January 10, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

3.5 years

First QC Date

November 28, 2021

Last Update Submit

December 3, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • MDS-UPDRS

    The motor portion of the Movement Disorder Society-Unified Parkinson´s (MDS-UPDRS, the minimum and maximum values are 0 and 72, respectively and the higher score, the worse patient condition)

    6 months

Secondary Outcomes (5)

  • DASH

    6 months

  • Static posturography

    6 months

  • TMWT

    6 months

  • TUG

    6 months

  • Grip strength

    6 months

Study Arms (4)

Intervention aerobic (IAER)

EXPERIMENTAL

Patients assigned to the IAER participated in fourty-eigth aerobic exercise therapy sessions over the course of six months.

Other: Aerobic training

Intervention photobiomodulation (IPBM)

EXPERIMENTAL

Patients assigned to the IPBM participated in fourty-eigth transcraneal photobiomodulation (PBM) theraphy sessions, using a therapeutic laser console, over the course of six months.

Other: Photobiomodulation

Intervention aerobic and photobiomodulation (IAER+PBM9

EXPERIMENTAL

Patients assigned to the IAER+PBM participated in the aerobic exercise therapy and the PBM one at the same time, during six months.

Other: Aerobic trainingOther: Photobiomodulation

Control (CO)

NO INTERVENTION

Patients assigned to the control (CO) did not participated in any kind of therapy, they just followed their usual weekly routine during six months

Interventions

Aerobic trainingOTHER

Cycling at the aerobic intensity

Intervention aerobic (IAER)Intervention aerobic and photobiomodulation (IAER+PBM9
PhotobiomodulationOTHER

Photons therapy

Intervention aerobic and photobiomodulation (IAER+PBM9Intervention photobiomodulation (IPBM)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis with idiopathic PD and rated 1-2 on the Hoehn and Yahr Scale.
  • No type of dementia as assessed by the mini-mental state examination.
  • Able to stand for 2 min without assistance.
  • Able to walk 10 m without assistance.

You may not qualify if:

  • Individuals were excluded if they suffered a neurological disease other than PD, if the subject has an implant of any kind in the head (e.g., stent, clipped aneurysm, embolized arteriovenous malformation, implantable shunt - Hakim valve) or if they did not meet the eligibility criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sport, University of León

León, Castille and León, 24071, Spain

Location

Related Publications (1)

  • Santos L, Burtscher J, de Taboada L. Parkinson's disease, aerobic exercise and photobiomodulation: a randomised controlled trial. J Neural Transm (Vienna). 2025 Oct 31. doi: 10.1007/s00702-025-03050-7. Online ahead of print.

    PMID: 41171380DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2021

First Posted

December 10, 2021

Study Start

January 10, 2021

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

ES(1)