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NCT Number: NCT06879821

High-intensity Functional Training 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

high intensity functional training

Other

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.

Other names: HIFT

Primary outcomes

  1. Short physical performance battery (SSPB)

    Time frame: 10 minutes

    Functional performance evaluation.

  2. Trail Making Test A y B

    Time frame: 15 minutes

    Evaluation of visual search, scanning, processing speed, mental flexibility and executive functions.

Secondary outcomes

  1. SF-12 Health Questionnaire

    Time frame: 10 minutes

    Assessing Perceived Quality of Life

  2. Barthel index

    Time frame: 10 minutes

    Evaluation of the degree of dependence in activities of daily living.

  3. fall risk assessment scale

    Time frame: 5 minutes

    Fall Risk Assessment

  4. 2-minute walk test (2-MWT)

    Time frame: 5 minutes

    Evaluation of functional capacity

  5. Mini Mental State Examination

    Time frame: 20 minutes

    Assessment of cognitive function

Other outcomes

  1. The Borg Scale

    Time frame: 2 minutes

    Rating of perceived exertion

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Aguilar Rodríguez, PHD

CONTACT

[email protected]

+34-963983855 ext. 51308

Sponsors and collaborators

Lead sponsor

Fundacion Para La Investigacion Hospital La Fe

Other

Registry information

Official study title

Effectiveness of a High-intensity Functional Training (HIFT) Program on Functional and Cognitive Performance in People with Parkinson's Disease.

Important dates

Study start
2022
Primary completion
2022
Study completion
2025
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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