Parkinson´s Disease, Aerobic Exercise and Photobiomodulation (PDAERPBM)

December 3, 2024 updated by: Luis Santos, University of Oviedo

Parkinson´s Disease, Aerobic Exercise and Photobiomodulation: a Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Castilla y León
      • León, Castilla y León, Spain, 24071
        • Department of Physical Education and Sport, University of León

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention aerobic (IAER)
Patients assigned to the IAER participated in fourty-eigth aerobic exercise therapy sessions over the course of six months.
Other: Aerobic training
Cycling at the aerobic intensity
Experimental: 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.
Other: Photobiomodulation
Photons therapy
Experimental: 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.
Other: Aerobic training
Cycling at the aerobic intensity
Other: Photobiomodulation
Photons therapy
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-UPDRS
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH
Time Frame: 6 months
The disabilities of the arm, shoulder and hand (DASH, the minimun and maximum values are 0 and 190, respectively and the higher score, the worse patient condition)
6 months
Static posturography
Time Frame: 6 months
The centre of pressure (CoP) parameters (these CoP parameters; Length, in mm, Area in mm2 and Speed, Xspeed and Yspeed in m/s will be combined to report the static posturography)
6 months
TMWT
Time Frame: 6 months
10 meters walking test (speed in seconds)
6 months
TUG
Time Frame: 6 months
Time up Go Test (speed in seconds)
6 months
Grip strength
Time Frame: 6 months
Grip strength in kg
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oviedo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

November 28, 2021

First Submitted That Met QC Criteria

November 28, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 295/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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