Parkinson DiseaseNCT06879821
High-intensity Functional Training on Functional and Cognitive Performance in People with Parkinson's Disease.
A study testing high intensity functional training in people with Parkinson Disease, run by Fundacion Para La Investigacion Hospital La Fe at 1 site in Spain.
Trial summary
Parkinson's disease (PD) is a progressive and chronic neurodegenerative disease, which presents signs and symptoms both motor (impaired gait, posture, balance, etc.) and cognitive (memory loss, dementia, etc.), all of which are causing disability and assuming a high economic cost. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- high intensity functional training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 14 Mar 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease.
- Stage I or II (Hoehn - Yahr Scale).
- Age between 45 and 80 years.
- Independent ambulation for 10 consecutive minutes.
- Regular physical exercise.
Who cannot join
- Medical contraindication for physical activity, deafness or limited hearing and very low vision or blind.
- Vestibular disorders that compromise balance.
- Psychotic or severe cognitive disorder.
- Decompensation or changes in medication.
- Surgical intervention in the last 6 months.
- Sedentary persons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Valencia
Valencia, Valencia, 46010
Marta Aguilar Rodríguez, 963 98 38 55 ext. 51308, marta.aguilar@uv.es
Ismael Vargas Villanueva, 620007093, ismaelvargasvillanueva@gmail.com
About this study
Official title: Effectiveness of a High-intensity Functional Training (HIFT) Program on Functional and Cognitive Performance in People with Parkinson's Disease.
Parkinson's disease (PD) is a progressive and chronic neurodegenerative disease, which presents signs and symptoms both motor (impaired gait, posture, balance, etc.) and cognitive (memory loss, dementia, etc.), all of which are causing disability and assuming a high economic cost. Currently, there are already certain authors who have shown how a high-intensity interval training (HIIT) protocol produces improvements in cognitive and physical performance in healthy adults6 and in people with multiple sclerosis. However, another modality has been created, such as high-intensity functional training (HIFT), which can benefit different populations, both healthy and pathological, due to the multimodal nature of the exercises. Thanks to multimodality, more aspects such as agility, coordination and precision of movements are worked on compared to unimodal HIIT programs that make this relevant work difficult in a person's daily life. The current study aims to demonstrate the effectiveness of a HIFT training protocol in a specific population, such as people with Parkinson's disease.
Read the detailed description
The hypothesis is that high-intensity functional training (HIFT), at a motor and cognitive level, provides a greater benefit than conventional programs of strength, balance and cognition, on the functionality and cognitive capacity of people with Parkinson's disease.
Overall objective:
- To assess whether the HIFT training program is associated with significant improvements in functional and cognitive capacity compared to conventional strength, balance and cognition programs in Parkinson's patients.
Secondary objectives:
- To assess whether the HIFT program improves the quality of life in patients with PD.
- To study whether the HIFT program reduces the degree of dependency of patients with PD.
- To determine if the HIFT program improves physical performance in patients with PD
- To assess whether the HIFT program reduces the risk of falls in patients with PD.
- To investigate whether the HIFT program improves balance in patients with PD.
- To determine if the HIFT program improves functional capacity in patients with PD.
- To study whether the HIFT program improves cognitive function in patients with PD
- Conditions
- Parkinson Disease
- Being tested
- high intensity functional training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity functional trainingOther
Also called HIFT
The pillar of rehabilitation will be based on high intensity functional training. 45-minute sessions divided into 5 minutes of warm-up, 35 minutes of functional exercises, and 5 minutes of going back to bed and cooling down. The 35 minutes of exercises were divided into 3 categories: lower extremity exercises, upper extremity exercises, and static and dynamic coordination and balance exercises. Each category will consist of 3 exercises per session, performing 2-3 series with a maximum of repetitions of 10-RM. The progression of the load will be progressively increased in weeks 3, 5 and 8 between 40-60% of the 1-RM.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will perform a high-intensity functional training program twice a week for 10 weeks. Receives: Other: high intensity functional training |
| Control Group | No intervention | The control group will continue to carry out their physical and cognitive exercise routine during the week, recording their activity in days and sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short physical performance battery (SSPB)
Functional performance evaluation.
Measured: 10 minutes
Trail Making Test A y B
Evaluation of visual search, scanning, processing speed, mental flexibility and executive functions.
Measured: 15 minutes
Secondary outcomes (5)
SF-12 Health Questionnaire
Assessing Perceived Quality of Life
Measured: 10 minutes
Barthel index
Evaluation of the degree of dependence in activities of daily living.
Measured: 10 minutes
fall risk assessment scale
Fall Risk Assessment
Measured: 5 minutes
2-minute walk test (2-MWT)
Evaluation of functional capacity
Measured: 5 minutes
Mini Mental State Examination
Assessment of cognitive function
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start14 Mar 2022
- Primary completion30 Nov 2022
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Model description
- Participants will be randomly divided into two groups: experimental group (EG) and control group (CG). The experimental group will perform a HIFT training program and the control group will follow their routine of physical and cognitive exercises, which will be recorded for control purposes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Para La Investigacion Hospital La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Aguilar-Rodriguez, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879821
- Sponsor's protocol ID
- 2022_TesisIVargas_UV
- Status last verified
- Feb 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a High-intensity Functional Training (HIFT) Program on Functional and Cognitive Performance in People with Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT06879821
- Acronym / sponsor ID
- 2022_TesisIVargas_UV
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Fundacion Para La Investigacion Hospital La FeUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 17 Mar 2025 (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.
Parkinson's disease (PD) is a progressive and chronic neurodegenerative disease, which presents signs and symptoms both motor (impaired gait, posture, balance, etc.) and cognitive (memory loss, dementia, etc.), all of which are causing disability and assuming a high economic cost. Currently, there are already certain authors who have shown how a high-intensity interval training (HIIT) protocol produces improvements in cognitive and physical performance in healthy adults6 and in people with multiple sclerosis. However, another modality has been created, such as high-intensity functional training (HIFT), which can benefit different populations, both healthy and pathological, due to the multimodal nature of the exercises. Thanks to multimodality, more aspects such as agility, coordination and precision of movements are worked on compared to unimodal HIIT programs that make this relevant work difficult in a person's daily life. The current study aims to demonstrate the effectiveness of a HIFT training protocol in a specific population, such as people with Parkinson's disease.
Detailed description
The hypothesis is that high-intensity functional training (HIFT), at a motor and cognitive level, provides a greater benefit than conventional programs of strength, balance and cognition, on the functionality and cognitive capacity of people with Parkinson's disease.
Overall objective:
- To assess whether the HIFT training program is associated with significant improvements in functional and cognitive capacity compared to conventional strength, balance and cognition programs in Parkinson's patients.
Secondary objectives:
- To assess whether the HIFT program improves the quality of life in patients with PD.
- To study whether the HIFT program reduces the degree of dependency of patients with PD.
- To determine if the HIFT program improves physical performance in patients with PD
- To assess whether the HIFT program reduces the risk of falls in patients with PD.
- To investigate whether the HIFT program improves balance in patients with PD.
- To determine if the HIFT program improves functional capacity in patients with PD.
- To study whether the HIFT program improves cognitive function in patients with PD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups: experimental group (EG) and control group (CG). The experimental group will perform a HIFT training program and the control group will follow their routine of physical and cognitive exercises, which will be recorded for control purposes.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: high intensity functional trainingThe experimental group will perform a high-intensity functional training program twice a week for 10 weeks. |
| Control Group | No intervention | –The control group will continue to carry out their physical and cognitive exercise routine during the week, recording their activity in days and sessions. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Parkinson's disease.
- Stage I or II (Hoehn - Yahr Scale).
- Age between 45 and 80 years.
- Independent ambulation for 10 consecutive minutes.
- Regular physical exercise.
Key exclusion criteria (6 listed)
- Medical contraindication for physical activity, deafness or limited hearing and very low vision or blind.
- Vestibular disorders that compromise balance.
- Psychotic or severe cognitive disorder.
- Decompensation or changes in medication.
- Surgical intervention in the last 6 months.
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 |
|---|---|---|
| high intensity functional trainingAlso: HIFTThe pillar of rehabilitation will be based on high intensity functional training. 45-minute sessions divided into 5 minutes of warm-up, 35 minutes of functional exercises, and 5 minutes of going back to bed and cooling down. The 35 minutes of exercises were divided into 3 categories: lower extremity exercises, upper extremity exercises, and static and dynamic coordination and balance exercises. Each category will consist of 3 exercises per session, performing 2-3 series with a maximum of repetitions of 10-RM. The progression of the load will be progressively increased in weeks 3, 5 and 8 between 40-60% of the 1-RM. | Other | Experimental group |
Primary outcome
Short physical performance battery (SSPB)
Time frame: 10 minutes
Functional performance evaluation.
Trail Making Test A y B
Time frame: 15 minutes
Evaluation of visual search, scanning, processing speed, mental flexibility and executive functions.
5 secondary outcomes
SF-12 Health Questionnaire
Time frame: 10 minutes
Barthel index
Time frame: 10 minutes
fall risk assessment scale
Time frame: 5 minutes
2-minute walk test (2-MWT)
Time frame: 5 minutes
Mini Mental State Examination
Time frame: 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity functional training in people with Parkinson Disease, run by Fundacion Para La Investigacion Hospital La Fe 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Aguilar Rodríguez, PHD (+34-963983855 ext. 51308, marta.aguilar@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short physical performance battery (SSPB) (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2025.