Neuro-Degenerative DiseaseNCT07163663
HIFT Training in People With Parkinson's Disease
A study testing Hight intensity functional trainning in people with Neuro-Degenerative Disease, run by University of Valencia at 2 sites 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 cause disability and assuming a high economic cost. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Neuro-Degenerative Disease
- What is being tested?
- Hight intensity functional trainning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Mar 2023to 25 Jun 2023
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease.
- Phase I or II (Hoehn - Yahr Scale).
- Independent ambulation for 10 consecutive minutes.
- Perform physical exercise on a regular basis.
Who cannot join
- Medical contraindication for physical activity, deafness or limited hearing and very low vision or blind.
- Vestibular disorders that compromise balance.
- Serious psychotic or cognitive disorder.
- Decompensation or changes in medication.
- Surgical intervention in the last 6 months.
- Sedentary people
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Ismael Vargas Villanueva
Elche, Valencia, 03200
Ismael Vargas Villanueva
Ibiza Town, Balearic Islands, 07800
About this study
Official title: Effectiveness of a HIFT Training Program on Cognitive and Functional 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 cause 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 adults 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. These are prescribed knowing the target group and involve the whole body using universal motor recruitment patterns in multiple planes of movement such as squats. The main hypothesis of the study 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.
Read the detailed description
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.
This pathology is characterized by the destruction, due to still unknown causes, of the dopaminergic neurons, which are found in a region of the brain called the basal ganglia, specifically in a part of the brainstem called the substantia nigra. These neurons act in the central nervous system and use dopamine as their primary neurotransmitter, responsible for transmitting the necessary information for the correct control of movements. For this reason, the result of its destruction involves slowing of movements along with lack of coordination.
These processes cause multiple deficits in higher cortical functions, affecting the motor and cognitive capacity of the individual and, therefore, negatively affecting the execution of both basic and instrumental daily activities.
PD is the second most common neurodegenerative disease after Alzheimer's and it presents in both sexes in a similar way, with a slight predominance in men. The World Health Organization already estimated in 2005 a global incidence of 4.5-19 new cases per year per 100,000 inhabitants and a global prevalence of 100-200 cases per 100,000 inhabitants, while a more recent report published by the European Parkinson's Disease Association estimates a worldwide prevalence for the year 2030 of between 8.7 and 9.3 million people. 70% of patients are people over 65 years of age, and 15% of all those affected are adults under 45 years of age. As a general rule, PD affects 1% of the population over 60 years of age, 2% of those over 70 years of age, and 3% of those over 803.
Due to all the physical and psychological consequences that can occur, the economic impact of this type of neurodegenerative pathology in the family nucleus is really great. The average annual expenditure per family unit for the different neurological pathologies is 13,063 euros. If the investigators focus on the EP, the amount is established up to the figure of 9,219 euros per year. This expense is usually progressive according to the degree of advancement of the disease, averaging an expense of 7,146 euros in the incipient phase of the disease, going through 8,491 euros in the intermediate phase and reaching 14,443 euros in the advanced phase. From all this it can be deduced that families are currently the main providers of support services for this type of patient, causing a very high cost for them. In this sense, it is important to highlight that a large percentage of patients have had to change their address or have had to carry out reforms to adapt the home to their situation (bathroom, adjustable bed, crane, restraints or barriers for the bed, among others).
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 7,8. These training programs are of a unimodal nature, that is, specific exercises for a specific joint and muscle group such as jumping, rowing, running or lifting weights, among others. 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. These are prescribed knowing the target group and involve the whole body using universal motor recruitment patterns in multiple planes of movement such as squats. 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. However, the functionality of the exercises provides added value, since it improves the motivational factor, which in turn increases adherence to the program9 and the obtaining of health benefits.
The current study aims to demonstrate the effectiveness of a HIFT training protocol in a specific population, such as people with Parkinson's disease.
- Conditions
- Neuro-Degenerative Disease
- Being tested
- Hight intensity functional trainning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hight intensity functional trainningOther
Warm-up phase: Low-intensity walking 30-50% MHR combined with dynamic mobility exercises
High Intensity Functional Training (HIFT)
The raised HIFT intervention proposal is divided into three exercises:
- Strength exercise of the lower limbs such as Sit to Stand / Stand to sit and elevation of the upper limbs up in a standing position or lateral gait with knee flexion of one limb among many others.
- Upper limb strength exercises: In a standing position with a medicine ball and in front of the wall, throw the ball against it and catch it o Walk while taking the medicine ball from right to left with smooth rotation of the trunk among many others.
- Coordination and balance exercises: Go up and down stairs or steps in four steps with arms stretched out in front of you and exercises such as standing, knee flexion and raising the contralateral hand with weights.
Cooling phase: Stretching of upper and lower limb muscle groups and head and neck muscles.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group followed their routine of both physical and cognitive exercises that were recorded for their control. Balance exercises, strength and aerobic exercise. They were assessed at the beginning and at the end of the 10 weeks. Receives: Other: Hight intensity functional trainning |
| HIFT group | Experimental | High-intensity functional training was carried out for 10 weeks. The rehabilitation pillar was 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 balance and coordination exercises. Each category consists of 3 exercises per session, performing 2 sets with a maximum of 10-RM repetitions. Load progression was progressively increased at weeks 3, 5, and 8 between 40-60% of the 1-RM. Receives: Other: Hight intensity functional trainning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic and neurological data registration form
Form for registering clinical history, sociodemographic data and neurological history of each participant, as well as personal and contact information.
Measured: At week 0
Short Form 12-item Questionnaire
Short Form 12-item Questionnaire is a generic health-related quality of life measurement instrument. It was born as an abbreviated version of the Short Form 36-item Questionnaire, since it consists of 12 items compared to the 36 items of the original and its administration time is approximately 2 minutes. The measurement is based on a Likert-type dichotomous scale, with a different number of response categories, between three and six. The scores of the twelve items were standardized to later place them in a range between 0 and 100. The objective is to evaluate the degree of well-being and functional capacity of people over 14 years of age. This test includes 2 dimensions that represent 8 health concepts most frequently used when measuring quality of life, as well as aspects related to illness. The higher the score, the healthier the person is.
Measured: At week 0 and 11
Barthel index
It was first described by Mahoney and Barthel in 1965 and is widely used by clinicians and researchers. The BI is defined as a generic measure that assesses the patient's level of independence with respect to performing some activities of daily living (ADL), through which different scores and weights are assigned according to the ability of the examined subject to carry out carry out these activities. The values assigned to each activity are based on the time and amount of physical assistance required if the patient is unable to perform that activity. It is made up of ten basic activities that include feeding, dressing and undressing, washing, using the toilet, urination control, stool control, transfers, use of personal hygiene, going up and down stairs and walking. The scores range from 0 to 10 points, passing through 5. 0 is totally dependent on the third person, 5 means that he needs some help and 10 is totally independent.
Measured: At week 0 and 11
Short physical performance battery (SSPB)
The test includes 3 spheres as described below:
- Balance test A. Stand with feet together side by side B. Semi-tandem C. Full tandem
- Walking speed test: Walk 4 meters and record the time.
- Chair rise test: Sit down and get up from the chair 5 times and record the time spent.
Each test is scored from 0 to 4. The total score ranges from 0 to 12 points.
Measured: At week 0 and 11
Fall Risk Assessment Score Scale
The Fall Risk Assessment Score Scale is a tool that was developed to predict the risk of falls in older people. It is based on five questions about the last year: history of falls in the last 12 months (2 points); decreased gait or noticeable changes in it (1.5 points); loss of balance in the last 12 months (1 point); visual deficit (1 point); decreased grip strength in the hands (1 point). Each variable is associated with a different score, indicated in parentheses at the end of each item. The final score of the scale varies between 0 and 6.5, in such a way that the higher the score, the greater the probability of suffering a fall. Thus, the cut-off value for this scale is 3.5 points, by which scores higher than this are considered to imply risk of falls.
Measured: At week 0 and 11
2 minute walk test (2-MWT)
The 2-MWT15 is a simple, inexpensive, and easy-to-administer test that consists of measuring the maximum distance that the patient is able to walk in 2 minutes, in a short walk in a corridor, simultaneously evaluating the heart rate, the saturation of oxygen and the degree of dyspnea using the Borg scale. Its physiological basis is that the distance achieved on a flat course during the defined time (2 minutes) is an expression of the individual's capacity for submaximal exercise, which allows an evaluation of this capacity in different respiratory pathologies. The 2-MWT influences, in addition to an underlying cardio-respiratory pathology, motivational and musculoskeletal factors that provide a global assessment of exercise capacity and can reflect the daily activity of patients better than other laboratory tests.
Measured: At week 0 and 11
Mini Mental State Examination
It is a brief test that assesses cognitive function. The questions included in the test attempt to examine various areas of cognitive function: orientation, registration, concentration, memory, language, and copying a figure. The Mini Mental State Examination total score is widely accepted as an indicator of the severity of cognitive impairment. Sensitivity is 87% and specificity is 82% in detecting dementia. Likewise, the values obtained in test-retest, 0.89, and from the inter-rater, 0.82, have also shown that Mini Mental State Examination is an effective instrument in the English language. Concurrent validity has been tested with extensive neuropsychological tests and also in longitudinal studies.
The test has been widely used in clinical practice and in research.
Measured: At week 0 and 11
Trail Making Test A y B
The test with part A and B measures visual search, scanning, processing speed, mental flexibility and executive functions. In Part A, the subject uses a pencil to connect a series of 25 circled numbers in numerical order on a sheet of paper with the prompt to do so in the shortest time possible. This makes it possible to accurately measure search tools and visual attention and psychomotor speed. In part B, a similar execution is required, with the exception that the person must alternate the sequence of numbers from 1 to 13 with letters from "A" to "L". In this way, we can obtain data on executive control, cognitive flexibility and alternation. The evaluated person is timed, obtaining the resulting time. If the examiner notices an error in the order of the lines drawn, she must interrupt the subject and correct the error without stopping the stopwatch during the correction.
Measured: At week 0 and 11.
Borg scale
It is a standardized and validated visual analog scale in Spanish, quick and easy to apply, which allows graphically evaluating the subjective perception of respiratory distress or physical effort exerted. The Borg scale has been used since the 1970s and the modified one since the 1980s, which has a range from 0 to 10. The scale determines the intensity of dyspnea and has a written expression added to the number, which helps to categorize the sensation of dyspnea of the subject to whom the test is performed. The result is recorded and coded. The interval between the ranges of the scale increases progressively, number 10 shows the greatest perception of dyspnea (of effort). The modified Borg scale is easy to use if the patient is properly instructed.
Measured: For 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Mar 2023
- Primary completion31 Mar 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neuro-Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- The people who will participate in the study will be randomly divided into two groups: experimental group (EG) and control group (CG). The experimental group will carry out a HIFT training program and the control group will follow their physical and cognitive exercise routine, which will be recorded for their control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Aguilar, University of Valencia
- Investigators
- MARTA AGUILAR, Study director, PROFESSOR DOCTOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163663
- Sponsor's protocol ID
- 301294
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan WLS, Pin TW. Reliability, validity and minimal detectable change of 2-minute walk test, 6-minute walk test and 10-meter walk test in frail older adults with dementia. Exp Gerontol. 2019 Jan;115:9-18. doi: 10.1016/j.exger.2018.11.001. Epub 2018 Nov 10.
PubMed 30423359Campbell E, Coulter EH, Paul L. High intensity interval training for people with multiple sclerosis: A systematic review. Mult Scler Relat Disord. 2018 Aug;24:55-63. doi: 10.1016/j.msard.2018.06.005. Epub 2018 Jun 13.
PubMed 29936326de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
PubMed 16713924Wens I, Dalgas U, Vandenabeele F, Grevendonk L, Verboven K, Hansen D, Eijnde BO. High Intensity Exercise in Multiple Sclerosis: Effects on Muscle Contractile Characteristics and Exercise Capacity, a Randomised Controlled Trial. PLoS One. 2015 Sep 29;10(9):e0133697. doi: 10.1371/journal.pone.0133697. eCollection 2015.
PubMed 26418222Coetsee C, Terblanche E. The effect of three different exercise training modalities on cognitive and physical function in a healthy older population. Eur Rev Aging Phys Act. 2017 Aug 10;14:13. doi: 10.1186/s11556-017-0183-5. eCollection 2017.
PubMed 28811842Weintraub D, Moberg PJ, Duda JE, Katz IR, Stern MB. Effect of psychiatric and other nonmotor symptoms on disability in Parkinson's disease. J Am Geriatr Soc. 2004 May;52(5):784-8. doi: 10.1111/j.1532-5415.2004.52219.x.
PubMed 15086662
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a HIFT Training Program on Cognitive and Functional Performance in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07163663
- Acronym / sponsor ID
- 301294
- Conditions
- Neuro-Degenerative Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 9 Sep 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 cause 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 adults 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. These are prescribed knowing the target group and involve the whole body using universal motor recruitment patterns in multiple planes of movement such as squats. The main hypothesis of the study 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.
Detailed description
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.
This pathology is characterized by the destruction, due to still unknown causes, of the dopaminergic neurons, which are found in a region of the brain called the basal ganglia, specifically in a part of the brainstem called the substantia nigra. These neurons act in the central nervous system and use dopamine as their primary neurotransmitter, responsible for transmitting the necessary information for the correct control of movements. For this reason, the result of its destruction involves slowing of movements along with lack of coordination.
These processes cause multiple deficits in higher cortical functions, affecting the motor and cognitive capacity of the individual and, therefore, negatively affecting the execution of both basic and instrumental daily activities.
PD is the second most common neurodegenerative disease after Alzheimer's and it presents in both sexes in a similar way, with a slight predominance in men. The World Health Organization already estimated in 2005 a global incidence of 4.5-19 new cases per year per 100,000 inhabitants and a global prevalence of 100-200 cases per 100,000 inhabitants, while a more recent report published by the European Parkinson's Disease Association estimates a worldwide prevalence for the year 2030 of between 8.7 and 9.3 million people. 70% of patients are people over 65 years of age, and 15% of all those affected are adults under 45 years of age. As a general rule, PD affects 1% of the population over 60 years of age, 2% of those over 70 years of age, and 3% of those over 803.
Due to all the physical and psychological consequences that can occur, the economic impact of this type of neurodegenerative pathology in the family nucleus is really great. The average annual expenditure per family unit for the different neurological pathologies is 13,063 euros. If the investigators focus on the EP, the amount is established up to the figure of 9,219 euros per year. This expense is usually progressive according to the degree of advancement of the disease, averaging an expense of 7,146 euros in the incipient phase of the disease, going through 8,491 euros in the intermediate phase and reaching 14,443 euros in the advanced phase. From all this it can be deduced that families are currently the main providers of support services for this type of patient, causing a very high cost for them. In this sense, it is important to highlight that a large percentage of patients have had to change their address or have had to carry out reforms to adapt the home to their situation (bathroom, adjustable bed, crane, restraints or barriers for the bed, among others).
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 7,8. These training programs are of a unimodal nature, that is, specific exercises for a specific joint and muscle group such as jumping, rowing, running or lifting weights, among others. 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. These are prescribed knowing the target group and involve the whole body using universal motor recruitment patterns in multiple planes of movement such as squats. 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. However, the functionality of the exercises provides added value, since it improves the motivational factor, which in turn increases adherence to the program9 and the obtaining of health benefits.
The current study aims to demonstrate the effectiveness of a HIFT training protocol in a specific population, such as people with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The people who will participate in the study will be randomly divided into two groups: experimental group (EG) and control group (CG). The experimental group will carry out a HIFT training program and the control group will follow their physical and cognitive exercise routine, which will be recorded for their control.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Hight intensity functional trainningThe control group followed their routine of both physical and cognitive exercises that were recorded for their control. Balance exercises, strength and aerobic exercise. They were assessed at the beginning and at the end of the 10 weeks. |
| HIFT group | Experimental | Other: Hight intensity functional trainningHigh-intensity functional training was carried out for 10 weeks. The rehabilitation pillar was 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 balance and coordination exercises. Each category consists of 3 exercises per session, performing 2 sets with a maximum of 10-RM repetitions. Load progression was progressively increased at weeks 3, 5, and 8 between 40-60% of the 1-RM. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Parkinson's disease.
- Phase I or II (Hoehn - Yahr Scale).
- Independent ambulation for 10 consecutive minutes.
- Perform physical exercise on a regular basis.
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.
- Serious psychotic or 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 |
|---|---|---|
| Hight intensity functional trainningWarm-up phase: Low-intensity walking 30-50% MHR combined with dynamic mobility exercises High Intensity Functional Training (HIFT) The raised HIFT intervention proposal is divided into three exercises: 1. Strength exercise of the lower limbs such as Sit to Stand / Stand to sit and elevation of the upper limbs up in a standing position or lateral gait with knee flexion of one limb among many others. 2. Upper limb strength exercises: In a standing position with a medicine ball and in front of the wall, throw the ball against it and catch it o Walk while taking the medicine ball from right to left with smooth rotation of the trunk among many others. 3. Coordination and balance exercises: Go up and down stairs or steps in four steps with arms stretched out in front of you and exercises such as standing, knee flexion and raising the contralateral hand with weights. Cooling phase: Stretching of upper and lower limb muscle groups and head and neck muscles. | Other | Control group, HIFT group |
Primary outcome
Sociodemographic and neurological data registration form
Time frame: At week 0
Form for registering clinical history, sociodemographic data and neurological history of each participant, as well as personal and contact information.
Short Form 12-item Questionnaire
Time frame: At week 0 and 11
Short Form 12-item Questionnaire is a generic health-related quality of life measurement instrument. It was born as an abbreviated version of the Short Form 36-item Questionnaire, since it consists of 12 items compared to the 36 items of the original and its administration time is approximately 2 minutes. The measurement is based on a Likert-type dichotomous scale, with a different number of response categories, between three and six. The scores of the twelve items were standardized to later place them in a range between 0 and 100. The objective is to evaluate the degree of well-being and functional capacity of people over 14 years of age. This test includes 2 dimensions that represent 8 health concepts most frequently used when measuring quality of life, as well as aspects related to illness. The higher the score, the healthier the person is.
Barthel index
Time frame: At week 0 and 11
It was first described by Mahoney and Barthel in 1965 and is widely used by clinicians and researchers. The BI is defined as a generic measure that assesses the patient's level of independence with respect to performing some activities of daily living (ADL), through which different scores and weights are assigned according to the ability of the examined subject to carry out carry out these activities. The values assigned to each activity are based on the time and amount of physical assistance required if the patient is unable to perform that activity. It is made up of ten basic activities that include feeding, dressing and undressing, washing, using the toilet, urination control, stool control, transfers, use of personal hygiene, going up and down stairs and walking. The scores range from 0 to 10 points, passing through 5. 0 is totally dependent on the third person, 5 means that he needs some help and 10 is totally independent.
Short physical performance battery (SSPB)
Time frame: At week 0 and 11
The test includes 3 spheres as described below: 1. Balance test A. Stand with feet together side by side B. Semi-tandem C. Full tandem 2. Walking speed test: Walk 4 meters and record the time. 3. Chair rise test: Sit down and get up from the chair 5 times and record the time spent. Each test is scored from 0 to 4. The total score ranges from 0 to 12 points.
Fall Risk Assessment Score Scale
Time frame: At week 0 and 11
The Fall Risk Assessment Score Scale is a tool that was developed to predict the risk of falls in older people. It is based on five questions about the last year: history of falls in the last 12 months (2 points); decreased gait or noticeable changes in it (1.5 points); loss of balance in the last 12 months (1 point); visual deficit (1 point); decreased grip strength in the hands (1 point). Each variable is associated with a different score, indicated in parentheses at the end of each item. The final score of the scale varies between 0 and 6.5, in such a way that the higher the score, the greater the probability of suffering a fall. Thus, the cut-off value for this scale is 3.5 points, by which scores higher than this are considered to imply risk of falls.
2 minute walk test (2-MWT)
Time frame: At week 0 and 11
The 2-MWT15 is a simple, inexpensive, and easy-to-administer test that consists of measuring the maximum distance that the patient is able to walk in 2 minutes, in a short walk in a corridor, simultaneously evaluating the heart rate, the saturation of oxygen and the degree of dyspnea using the Borg scale. Its physiological basis is that the distance achieved on a flat course during the defined time (2 minutes) is an expression of the individual's capacity for submaximal exercise, which allows an evaluation of this capacity in different respiratory pathologies. The 2-MWT influences, in addition to an underlying cardio-respiratory pathology, motivational and musculoskeletal factors that provide a global assessment of exercise capacity and can reflect the daily activity of patients better than other laboratory tests.
Mini Mental State Examination
Time frame: At week 0 and 11
It is a brief test that assesses cognitive function. The questions included in the test attempt to examine various areas of cognitive function: orientation, registration, concentration, memory, language, and copying a figure. The Mini Mental State Examination total score is widely accepted as an indicator of the severity of cognitive impairment. Sensitivity is 87% and specificity is 82% in detecting dementia. Likewise, the values obtained in test-retest, 0.89, and from the inter-rater, 0.82, have also shown that Mini Mental State Examination is an effective instrument in the English language. Concurrent validity has been tested with extensive neuropsychological tests and also in longitudinal studies. The test has been widely used in clinical practice and in research.
Trail Making Test A y B
Time frame: At week 0 and 11.
The test with part A and B measures visual search, scanning, processing speed, mental flexibility and executive functions. In Part A, the subject uses a pencil to connect a series of 25 circled numbers in numerical order on a sheet of paper with the prompt to do so in the shortest time possible. This makes it possible to accurately measure search tools and visual attention and psychomotor speed. In part B, a similar execution is required, with the exception that the person must alternate the sequence of numbers from 1 to 13 with letters from "A" to "L". In this way, we can obtain data on executive control, cognitive flexibility and alternation. The evaluated person is timed, obtaining the resulting time. If the examiner notices an error in the order of the lines drawn, she must interrupt the subject and correct the error without stopping the stopwatch during the correction.
Borg scale
Time frame: For 10 weeks
It is a standardized and validated visual analog scale in Spanish, quick and easy to apply, which allows graphically evaluating the subjective perception of respiratory distress or physical effort exerted. The Borg scale has been used since the 1970s and the modified one since the 1980s, which has a range from 0 to 10. The scale determines the intensity of dyspnea and has a written expression added to the number, which helps to categorize the sensation of dyspnea of the subject to whom the test is performed. The result is recorded and coded. The interval between the ranges of the scale increases progressively, number 10 shows the greatest perception of dyspnea (of effort). The modified Borg scale is easy to use if the patient is properly instructed.
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 9 Sep 2025.
- Results publication: PubMed 30423359Chan WLS, Pin TW. Reliability, validity and minimal detectable change of 2-minute walk test, 6-minute walk test and 10-meter walk test in frail older adults with dementia. Exp Gerontol. 2019 Jan;115:9-18. doi: 10.1016/j.exger.2018.11.001. Epub 2018 Nov 10.
- Results publication: PubMed 29936326Campbell E, Coulter EH, Paul L. High intensity interval training for people with multiple sclerosis: A systematic review. Mult Scler Relat Disord. 2018 Aug;24:55-63. doi: 10.1016/j.msard.2018.06.005. Epub 2018 Jun 13.
- Results publication: PubMed 16713924de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
- Results publication: PubMed 26418222Wens I, Dalgas U, Vandenabeele F, Grevendonk L, Verboven K, Hansen D, Eijnde BO. High Intensity Exercise in Multiple Sclerosis: Effects on Muscle Contractile Characteristics and Exercise Capacity, a Randomised Controlled Trial. PLoS One. 2015 Sep 29;10(9):e0133697. doi: 10.1371/journal.pone.0133697. eCollection 2015.
- Results publication: PubMed 28811842Coetsee C, Terblanche E. The effect of three different exercise training modalities on cognitive and physical function in a healthy older population. Eur Rev Aging Phys Act. 2017 Aug 10;14:13. doi: 10.1186/s11556-017-0183-5. eCollection 2017.
- Results publication: PubMed 15086662Weintraub D, Moberg PJ, Duda JE, Katz IR, Stern MB. Effect of psychiatric and other nonmotor symptoms on disability in Parkinson's disease. J Am Geriatr Soc. 2004 May;52(5):784-8. doi: 10.1111/j.1532-5415.2004.52219.x.
- Reference values of the Short Physical Performance Battery for patients aged 70 and over in primary health careLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
MARTA AGUILAR study director
PROFESSOR DOCTOR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hight intensity functional trainning in people with Neuro-Degenerative Disease, run by University of Valencia at 2 sites 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 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: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sociodemographic and neurological data registration form (time frame: At week 0). The study lists 9 primary outcomes in all. 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 NCT07163663, which also lists 6 linked publications.
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 9 Sep 2025.