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Neurodegenerative DiseasesNCT05482776

HIFT in People With Parkinson's Disease

A study testing High intensity functional training and classic training group in people with Neurodegenerative Diseases, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Neurodegenerative Diseases
What is being tested?
High intensity functional training and classic training group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSpain
Study dates
15 Apr 2022to 5 Dec 2022
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

1 site in 1 country.

Spain1 site
  • Asociación de Esclerosis Múltiple de Ibiza y Formentera (AEMIF)

    Ibiza Town, Balearic Islands, 07800

Other trials in Spain

About this study

Official title: Effectiveness of a HIFT Program on Cognitive and Functional Performance in People With Parkinson's Disease: Randomised Pilot Trial

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 primary neurotransmitter, responsible for transmitting the necessary information for the correct control of movements. For this reason, the result of 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. On the PD, 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 adults and in people with multiple sclerosis. 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 program 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.

Being tested
High intensity functional training, classic training group
Medical subject headings
Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High intensity functional trainingOther

    HIFT is an exercise modality that emphasizes functional movements through exercises that involve a large amount of muscle mass and that can be adapted to the level of physical condition of each subject. Although it has similarities and is compared to HIIT, they are different.

    In this discipline, functional exercises with an external load such as squats, pull-ups, or functional exercises with our own weight, are mixed with other aerobics such as running, rowing or cycling. This mix results in a high-intensity training that improves parameters of physical condition in general and performance.

  • classic training groupOther

    This intervention consists of carrying out their conventional weekly physiotherapy training sessions where strength, coordination and balance are trained.

Study groups in NCT05482776
Study groupRoleWhat they receive
classic training groupActive comparatorThe classic training 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: classic training group
HIFT groupExperimentalThe experimental group performed 10-weeks training program consisted in Warm-up phase and HIFT training. They were assessed at the beginning and at the end of the 10 weeks.
Receives: Other: High intensity functional training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Proportion of randomized participants relative to the number of screened participants. Feasibility criteria > 75 %

    Measured: Baseline

  2. Consent rate

    Proportion of participants who provide consent relative to the number approached for participation. Feasibility criteria > 70%

    Measured: Baseline

  3. Adverse effects rate

    Proportion of participants who suffered falls, fatigue or situations that prevent them from continuing with the training. feasibility criteria < 30 %

    Measured: through intervention completion, an average of 11 weeks

  4. Trial completion rate

    Proportion of randomized participants who complete the trial. Feasibility criteria > 80 %

    Measured: 11 weeks

  5. Training completion rate

    Proportion of training sessions carried out with respect to the total.Feasibility criteria >70 %

    Measured: 10 weeks

  6. Divergent treatment decision rate

    Proportion of exercises modified based on risk of falls. Feasibility criteria < 30 %

    Measured: 10 weeks

  7. Assessment test performance ratio

    Proportion of patients able to perform all screening tests.Feasibility criteria >85 %

    Measured: 11 weeks

Secondary outcomes (6)
  1. Mini Mental State Examination (MMSE)

    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 MMSE 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 MMS 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: Baseline and 11 week

  2. Trail making Test (TMT)

    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: Baseline and 11 week

  3. Short physical performance battery (SSPB)

    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.

    Measured: Baseline and 11 week

  4. 2 minute walk test (2-MWT)

    The 2-MWT 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: Baseline and 11 week

  5. Barthel index

    It was first described by Mahoney and Barthel in 1965 and is widely used by clinicians and researchers. The Barthel Index 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: Baseline and 11 week

  6. 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: through intervention completion, an average of 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start15 Apr 2022
  3. Primary completion3 Nov 2022
  4. Study completion5 Dec 2022

Resources

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05482776
Sponsor's protocol ID
Randomized pilot trial
Status last verified
Mar 2022
First submitted
7 Jul 2022
Last updated
28 Aug 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 30423359
  • Campbell 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 29936326
  • de 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 16713924
  • Wens 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 26418222
  • Coetsee 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 28811842
  • Weintraub 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

Questions about this trial

What is this clinical trial studying?

A study testing High intensity functional training and classic training group in people with Neurodegenerative Diseases, run by University of Valencia 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 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 28 Aug 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?

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?

Recruitment rate (time frame: Baseline). The study lists 7 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 NCT05482776, 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 28 Aug 2025.

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