Back to resultsParkinson´s Disease, Aerobic Exercise and Photobiomodulation (PDAERPBM)
Primary Purpose
Parkinson Disease
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Aerobic training
Photobiomodulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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.
Sites / Locations
- Department of Physical Education and Sport, University of León
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Intervention aerobic (IAER)
Intervention photobiomodulation (IPBM)
Intervention aerobic and photobiomodulation (IAER+PBM9
Control (CO)
Arm Description
Patients assigned to the IAER participated in fourty-eigth aerobic exercise therapy sessions over the course of six months.
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.
Patients assigned to the IAER+PBM participated in the aerobic exercise therapy and the PBM one at the same time, during six months.
Patients assigned to the control (CO) did not participated in any kind of therapy, they just followed their usual weekly routine during six months
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
TMWT
10 meters walking test (speed in seconds)
TUG
Time up Go Test (speed in seconds)
Grip strength
Grip strength in kg
Full Information
NCT ID
NCT05152706
First Posted
November 28, 2021
Last Updated
November 1, 2022
Sponsor
University of Oviedo
1. Study Identification
Unique Protocol Identification Number
NCT05152706
Brief Title
Parkinson´s Disease, Aerobic Exercise and Photobiomodulation
Acronym
PDAERPBM
Official Title
Parkinson´s Disease, Aerobic Exercise and Photobiomodulation: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
June 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oviedo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention aerobic (IAER)
Arm Type
Experimental
Arm Description
Patients assigned to the IAER participated in fourty-eigth aerobic exercise therapy sessions over the course of six months.
Arm Title
Intervention photobiomodulation (IPBM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention aerobic and photobiomodulation (IAER+PBM9
Arm Type
Experimental
Arm Description
Patients assigned to the IAER+PBM participated in the aerobic exercise therapy and the PBM one at the same time, during six months.
Arm Title
Control (CO)
Arm Type
No Intervention
Arm Description
Patients assigned to the control (CO) did not participated in any kind of therapy, they just followed their usual weekly routine during six months
Intervention Type
Other
Intervention Name(s)
Aerobic training
Intervention Description
Cycling at the aerobic intensity
Intervention Type
Other
Intervention Name(s)
Photobiomodulation
Intervention Description
Photons therapy
Primary Outcome Measure Information:
Title
MDS-UPDRS
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
DASH
Description
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)
Time Frame
6 months
Title
Static posturography
Description
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)
Time Frame
6 months
Title
TMWT
Description
10 meters walking test (speed in seconds)
Time Frame
6 months
Title
TUG
Description
Time up Go Test (speed in seconds)
Time Frame
6 months
Title
Grip strength
Description
Grip strength in kg
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Physical Education and Sport, University of León
City
León
State/Province
Castilla Y León
ZIP/Postal Code
24071
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Parkinson´s Disease, Aerobic Exercise and Photobiomodulation
We'll reach out to this number within 24 hrs