Parkinson´s Disease, Aerobic Exercise and Photobiomodulation

Study Overview
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Aerobic training
* Other: Photobiomodulation


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention aerobic (IAER)<br>Patients assigned to the IAER participated in fourty-eigth aerobic exercise therapy sessions over the course of six months. | Other: Aerobic training<br>* Cycling at the aerobic intensity<br>|
| Experimental: Intervention photobiomodulation (IPBM)<br>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<br>* Photons therapy<br>|
| Experimental: Intervention aerobic and photobiomodulation (IAER+PBM9<br>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<br>* Cycling at the aerobic intensity<br>Other: Photobiomodulation<br>* Photons therapy<br>|
| No Intervention: Control (CO)<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH | 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 | 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 | 10 meters walking test (speed in seconds) | 6 months | 
| TUG | Time up Go Test (speed in seconds) | 6 months | 
| Grip strength | Grip strength in kg | 6 months |