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

Not Applicable

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06879821
• Lead Sponsor: Fundacion Para La Investigacion Hospital La Fe

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

Study Timeline

• Study Start: 2022-03-14
• Primary Completion: 2022-11-30
• Status Verified: 2025-02
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Valencia; 🇪🇸 Valencia, Spain