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Recruiting NCT06879821

High-intensity Functional Training on Functional and Cognitive Performance in People with Parkinson's Disease.

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: high intensity functional training.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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:

1. To assess whether the HIFT program improves the quality of life in patients with PD. 2. To study whether the HIFT program reduces the degree of dependency of patients with PD. 3. To determine if the HIFT program improves physical performance in patients with PD 4. To assess whether the HIFT program reduces the risk of falls in patients with PD. 5. To investigate whether the HIFT program improves balance in patients with PD. 6. To determine if the HIFT program improves functional capacity in patients with PD. 7. To study whether the HIFT program improves cognitive function in patients with PD

Interventions

  • Other high intensity functional training
    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 repetit

Primary outcome measures

  • Short physical performance battery (SSPB) [Time frame: 10 minutes]
  • Trail Making Test A y B [Time frame: 15 minutes]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • University of Valencia — Valencia

Identifiers

NCT: NCT06879821 · 2022_TesisIVargas_UV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗