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

NCT ID: NCT06879821

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2025-04-30

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.

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

high intensity functional training

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

HIFT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Para La Investigacion Hospital La Fe

OTHER

Sponsor Role: lead

Responsible Party

Marta Aguilar-Rodriguez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Valencia

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Marta Aguilar Rodríguez, PHD

Role: CONTACT

marta.aguilar@uv.es

+34-963983855 ext. 51308

Facility Contacts

Marta Aguilar Rodríguez

Role: primary

marta.aguilar@uv.es

963 98 38 55 ext. 51308

Ismael Vargas Villanueva

Role: backup

ismaelvargasvillanueva@gmail.com

620007093

Other Identifiers

2022_TesisIVargas_UV

Identifier Type: -

Identifier Source: org_study_id