Clinical trial NCT06879821: High-intensity Functional Training on Functional and Cognitive Performance in People with Parkinson's Disease.
Official title: Effectiveness of a High-intensity Functional Training (HIFT) Program on Functional and Cognitive Performance in People with Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Fundacion Para La Investigacion Hospital La Fe
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Short physical performance battery (SSPB)
timeFrame: 10 minutes
measure: Trail Making Test A y B
timeFrame: 15 minutes
Secondary outcomes:
measure: SF-12 Health Questionnaire
timeFrame: 10 minutes
measure: Barthel index
timeFrame: 10 minutes
measure: fall risk assessment scale
timeFrame: 5 minutes
measure: 2-minute walk test (2-MWT)
timeFrame: 5 minutes
measure: Mini Mental State Examination
timeFrame: 20 minutes
Other outcomes:
measure: The Borg Scale
timeFrame: 2 minutes
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
References: