HIFT Training in People With Parkinson's Disease

NCT ID: NCT07163663

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-06-25

Brief Summary

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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

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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

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Neuro-Degenerative Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Randomization will be performed using an Excel spreadsheet, following random number filters.

Study Groups

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Control group

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.

Group Type ACTIVE_COMPARATOR

Hight intensity functional trainning

Intervention Type OTHER

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:

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.

HIFT group

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.

Group Type EXPERIMENTAL

Hight intensity functional trainning

Intervention Type OTHER

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:

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.

Interventions

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Hight intensity functional trainning

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:

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Parkinson's disease.
2. Phase I or II (Hoehn - Yahr Scale).
3. Independent ambulation for 10 consecutive minutes.
4. Perform physical exercise on a regular basis.

Exclusion Criteria

1. Medical contraindication for physical activity, deafness or limited hearing and very low vision or blind.
2. Vestibular disorders that compromise balance.
3. Serious psychotic or cognitive disorder.
4. Decompensation or changes in medication.
5. Surgical intervention in the last 6 months.
6. Sedentary people
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Marta Aguilar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MARTA AGUILAR

Role: STUDY_DIRECTOR

PROFESSOR DOCTOR

Locations

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Ismael Vargas Villanueva

Ibiza Town, Balearic Islands, Spain

Site Status

Ismael Vargas Villanueva

Elche, Valencia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 30423359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29936326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16713924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26418222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28811842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15086662 (View on PubMed)

Related Links

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http://www.clinicalkey.es

Reference values of the Short Physical Performance Battery for patients aged 70 and over in primary health care

Other Identifiers

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301294

Identifier Type: -

Identifier Source: org_study_id

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