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RecruitingNCT06879821Updated Mar 17, 2025

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

An interventional study of high intensity functional training in Parkinson Disease, sponsored by Fundacion Para La Investigacion Hospital La Fe. Recruiting at 1 site in Spain. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Fundacion Para La Investigacion Hospital La Fe · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Mar 2022, registered Mar 2025).
  • Started Mar 2022; still recruiting 4 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 34 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Fundacion Para La Investigacion Hospital La Fe is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
34 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • Otherhigh 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.

    Also known as: HIFT

06

What researchers measure

Primary outcomes

  1. Short physical performance battery (SSPB)

    Functional performance evaluation.

    Time frame: 10 minutes

  2. Trail Making Test A y B

    Evaluation of visual search, scanning, processing speed, mental flexibility and executive functions.

    Time frame: 15 minutes

Secondary outcomes

  1. SF-12 Health Questionnaire

    Assessing Perceived Quality of Life

    Time frame: 10 minutes

  2. Barthel index

    Evaluation of the degree of dependence in activities of daily living.

    Time frame: 10 minutes

  3. fall risk assessment scale

    Fall Risk Assessment

    Time frame: 5 minutes

  4. 2-minute walk test (2-MWT)

    Evaluation of functional capacity

    Time frame: 5 minutes

  5. Mini Mental State Examination

    Assessment of cognitive function

    Time frame: 20 minutes

Other outcomes

  1. The Borg Scale

    Rating of perceived exertion

    Time frame: 2 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06879821
Lead sponsor
Fundacion Para La Investigacion Hospital La Fe
Responsible party
Marta Aguilar-Rodriguez (Assistant Professor, University of Valencia) — Principal investigator
First posted
Mar 17, 2025
Start date
Mar 14, 2022
Primary completion
Nov 30, 2022
Completion
Apr 30, 2025 (estimated)
Last update
Mar 17, 2025

Study contacts

Marta Aguilar Rodríguez, PHD
Contact
marta.aguilar@uv.es
+34-963983855 ext. 51308

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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