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Parkinson´s Disease, Aerobic Exercise and Photobiomodulation

NCT ID: NCT05152706

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention aerobic (IAER)

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

Group Type EXPERIMENTAL

Aerobic training

Intervention Type OTHER

Cycling at the aerobic intensity

Intervention photobiomodulation (IPBM)

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.

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type OTHER

Photons therapy

Intervention aerobic and photobiomodulation (IAER+PBM9

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

Group Type EXPERIMENTAL

Aerobic training

Intervention Type OTHER

Cycling at the aerobic intensity

Photobiomodulation

Intervention Type OTHER

Photons therapy

Control (CO)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic training

Cycling at the aerobic intensity

Intervention Type OTHER

Photobiomodulation

Photons therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oviedo

OTHER

Sponsor Role lead

Responsible Party

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Luis Santos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Physical Education and Sport, University of León

León, Castille and León, Spain

Site Status

Countries

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Spain

Other Identifiers

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No. 295/19

Identifier Type: -

Identifier Source: org_study_id