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

NCT06879821 | Recruiting DMC

• 1 other identifier: 2022_TesisIVargas_UV
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• SF-12 Health Questionnaire

  10 minutes

• Barthel index

  10 minutes

• fall risk assessment scale

  5 minutes

• 2-minute walk test (2-MWT)

  5 minutes

• Mini Mental State Examination

  20 minutes

Other Outcomes (1)

• The Borg Scale

  2 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will perform a high-intensity functional training program twice a week for 10 weeks.

Other: high intensity functional training

Control Group

NO INTERVENTION

The control group will continue to carry out their physical and cognitive exercise routine during the week, recording their activity in days and sessions.

Interventions

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.

Also known as: HIFT

Experimental group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Para La Investigacion Hospital La Fe: lead

Study Sites (1)

University of Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marta Aguilar Rodríguez, PHD

CONTACT

+34-963983855; marta.aguilar@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly divided into two groups: experimental group (EG) and control group (CG). The experimental group will perform a HIFT training program and the control group will follow their routine of physical and cognitive exercises, which will be recorded for control purposes.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: March 14, 2022
• Primary Completion: November 30, 2022
• Study Completion: April 30, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)