Parkinson DiseasePDAERPBMNCT05152706
Parkinson´s Disease, Aerobic Exercise and Photobiomodulation
A study testing Aerobic training and Photobiomodulation in people with Parkinson Disease, run by University of Oviedo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Aerobic training and Photobiomodulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Physical Education and Sport, University of León
León, Castille and León, 24071
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Aerobic training, Photobiomodulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
Cycling at the aerobic intensity
PhotobiomodulationOther
Photons therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention aerobic (IAER) | Experimental | Patients assigned to the IAER participated in fourty-eigth aerobic exercise therapy sessions over the course of six months. Receives: 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. Receives: 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. Receives: Other: Aerobic training; Other: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (5)
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)
Measured: 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)
Measured: 6 months
TMWT
10 meters walking test (speed in seconds)
Measured: 6 months
TUG
Time up Go Test (speed in seconds)
Measured: 6 months
Grip strength
Grip strength in kg
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start10 Jan 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Santos, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152706
- Sponsor's protocol ID
- No. 295/19
- Acronym
- PDAERPBM
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santos L, Burtscher J, de Taboada L. Parkinson's disease, aerobic exercise and photobiomodulation: a randomised controlled trial. J Neural Transm (Vienna). 2026 Jul;133(7):1379-1396. doi: 10.1007/s00702-025-03050-7. Epub 2025 Oct 31.
PubMed 41171380
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson´s Disease, Aerobic Exercise and Photobiomodulation: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05152706
- Acronym / sponsor ID
- PDAERPBM / No. 295/19
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention aerobic (IAER) | Experimental | Other: Aerobic trainingPatients assigned to the IAER participated in fourty-eigth aerobic exercise therapy sessions over the course of six months. |
| Intervention photobiomodulation (IPBM) | Experimental | Other: PhotobiomodulationPatients assigned to the IPBM participated in fourty-eigth transcraneal photobiomodulation (PBM) theraphy sessions, using a therapeutic laser console, over the course of six months. |
| Intervention aerobic and photobiomodulation (IAER+PBM9 | Experimental | Other: Aerobic training, Other: PhotobiomodulationPatients assigned to the IAER+PBM participated in the aerobic exercise therapy and the PBM one at the same time, during six months. |
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingCycling at the aerobic intensity | Other | Intervention aerobic (IAER), Intervention aerobic and photobiomodulation (IAER+PBM9 |
| PhotobiomodulationPhotons therapy | Other | Intervention aerobic and photobiomodulation (IAER+PBM9, Intervention photobiomodulation (IPBM) |
Primary outcome
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)
5 secondary outcomes
DASH
Time frame: 6 months
Static posturography
Time frame: 6 months
TMWT
Time frame: 6 months
TUG
Time frame: 6 months
Grip strength
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 41171380Santos L, Burtscher J, de Taboada L. Parkinson's disease, aerobic exercise and photobiomodulation: a randomised controlled trial. J Neural Transm (Vienna). 2026 Jul;133(7):1379-1396. doi: 10.1007/s00702-025-03050-7. Epub 2025 Oct 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training and Photobiomodulation in people with Parkinson Disease, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05152706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.