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

Effectiveness of a High-intensity Functional Training (HIFT) Program 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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: high intensity functional training

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

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Aguilar Rodríguez, PHD; Phone Number: 51308 +34-963983855; Email: marta.aguilar@uv.es

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Recruiting
    • University of Valencia
    • Contact: Marta Aguilar Rodríguez; Phone Number: 51308 963 98 38 55; Email: marta.aguilar@uv.es
    • Contact: Ismael Vargas Villanueva; Phone Number: 620007093; Email: ismaelvargasvillanueva@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The experimental group will perform a high-intensity functional training program twice a week for 10 weeks.	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 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
No Intervention: Control Group; The control group will continue to carry out their physical and cognitive exercise routine during the week, recording their activity in days and sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short physical performance battery (SSPB)	Functional performance evaluation.	10 minutes
Trail Making Test A y B	Evaluation of visual search, scanning, processing speed, mental flexibility and executive functions.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-12 Health Questionnaire	Assessing Perceived Quality of Life	10 minutes
Barthel index	Evaluation of the degree of dependence in activities of daily living.	10 minutes
fall risk assessment scale	Fall Risk Assessment	5 minutes
2-minute walk test (2-MWT)	Evaluation of functional capacity	5 minutes
Mini Mental State Examination	Assessment of cognitive function	20 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Borg Scale	Rating of perceived exertion	2 minutes

Collaborators and Investigators

• Sponsor: Fundacion Para La Investigacion Hospital La Fe

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 2022_TesisIVargas_UV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No