HIFT in People With Parkinson's Disease

NCT05482776 | Completed

• 1 other identifier: Randomized pilot trial
• Study Type: interventional
• Target: 14
• 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 cause 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 adults 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. These are prescribed knowing the target group and involve the whole body using universal motor recruitment patterns in multiple planes of movement such as squats. The main hypothesis of the study 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.

Conditions

Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (7)

• Recruitment rate

  Proportion of randomized participants relative to the number of screened participants. Feasibility criteria \> 75 %

  Baseline

• Consent rate

  Proportion of participants who provide consent relative to the number approached for participation. Feasibility criteria \> 70%

  Baseline

• Adverse effects rate

  Proportion of participants who suffered falls, fatigue or situations that prevent them from continuing with the training. feasibility criteria \< 30 %

  through intervention completion, an average of 11 weeks

• Trial completion rate

  Proportion of randomized participants who complete the trial. Feasibility criteria \> 80 %

  11 weeks

• Training completion rate

  Proportion of training sessions carried out with respect to the total.Feasibility criteria \>70 %

  10 weeks

• Divergent treatment decision rate

  Proportion of exercises modified based on risk of falls. Feasibility criteria \< 30 %

  10 weeks

• Assessment test performance ratio

  Proportion of patients able to perform all screening tests.Feasibility criteria \>85 %

  11 weeks

Secondary Outcomes (6)

• Mini Mental State Examination (MMSE)

  Baseline and 11 week

• Trail making Test (TMT)

  Baseline and 11 week

• Short physical performance battery (SSPB)

  Baseline and 11 week

• 2 minute walk test (2-MWT)

  Baseline and 11 week

• Barthel index

  Baseline and 11 week

Study Arms (2)

classic training group

ACTIVE COMPARATOR

The classic training group followed their routine of both physical and cognitive exercises that were recorded for their control. Balance exercises, strength and aerobic exercise. They were assessed at the beginning and at the end of the 10 weeks.

Other: classic training group

HIFT group

EXPERIMENTAL

The experimental group performed 10-weeks training program consisted in Warm-up phase and HIFT training. They were assessed at the beginning and at the end of the 10 weeks.

Other: High intensity functional training

Interventions

High intensity functional training OTHER

HIFT is an exercise modality that emphasizes functional movements through exercises that involve a large amount of muscle mass and that can be adapted to the level of physical condition of each subject. Although it has similarities and is compared to HIIT, they are different. In this discipline, functional exercises with an external load such as squats, pull-ups, or functional exercises with our own weight, are mixed with other aerobics such as running, rowing or cycling. This mix results in a high-intensity training that improves parameters of physical condition in general and performance.

HIFT group

classic training group OTHER

This intervention consists of carrying out their conventional weekly physiotherapy training sessions where strength, coordination and balance are trained.

classic training group

Eligibility Criteria

• Age: 45 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.
• Phase I or II (Hoehn - Yahr Scale).
• Independent ambulation for 10 consecutive minutes.
• Perform physical exercise on a regular basis.

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.
• Serious psychotic or cognitive disorder.
• Decompensation or changes in medication.
• Surgical intervention in the last 6 months.
• Sedentary people

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Asociación de Esclerosis Múltiple de Ibiza y Formentera (AEMIF)

Ibiza Town, Balearic Islands, 07800, Spain

Location

Related Publications (6)

• Chan WLS, Pin TW. Reliability, validity and minimal detectable change of 2-minute walk test, 6-minute walk test and 10-meter walk test in frail older adults with dementia. Exp Gerontol. 2019 Jan;115:9-18. doi: 10.1016/j.exger.2018.11.001. Epub 2018 Nov 10.

  PMID: 30423359 BACKGROUND

• Campbell E, Coulter EH, Paul L. High intensity interval training for people with multiple sclerosis: A systematic review. Mult Scler Relat Disord. 2018 Aug;24:55-63. doi: 10.1016/j.msard.2018.06.005. Epub 2018 Jun 13.

  PMID: 29936326 BACKGROUND

• de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.

  PMID: 16713924 BACKGROUND

• Wens I, Dalgas U, Vandenabeele F, Grevendonk L, Verboven K, Hansen D, Eijnde BO. High Intensity Exercise in Multiple Sclerosis: Effects on Muscle Contractile Characteristics and Exercise Capacity, a Randomised Controlled Trial. PLoS One. 2015 Sep 29;10(9):e0133697. doi: 10.1371/journal.pone.0133697. eCollection 2015.

  PMID: 26418222 BACKGROUND

• Coetsee C, Terblanche E. The effect of three different exercise training modalities on cognitive and physical function in a healthy older population. Eur Rev Aging Phys Act. 2017 Aug 10;14:13. doi: 10.1186/s11556-017-0183-5. eCollection 2017.

  PMID: 28811842 BACKGROUND

• Weintraub D, Moberg PJ, Duda JE, Katz IR, Stern MB. Effect of psychiatric and other nonmotor symptoms on disability in Parkinson's disease. J Am Geriatr Soc. 2004 May;52(5):784-8. doi: 10.1111/j.1532-5415.2004.52219.x.

  PMID: 15086662 BACKGROUND

Related Links

• Reference values of the Short Physical Performance Battery for patients aged 70 and over in primary health care

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• MARTA AGUILAR RODRÍGUEZ, PhD.

  Physiotherapy Department. University of Valencia. Spain

  STUDY DIRECTOR

Study Design

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

Model Details: The people who will participate in the study will be randomly divided into two groups: experimental group (EG) and control group (CG). The experimental group will carry out a HIFT training program and the control group will follow their physical and cognitive exercise routine, which will be recorded for their control.

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: August 1, 2022
• Study Start: April 15, 2022
• Primary Completion: November 3, 2022
• Study Completion: December 5, 2022
• Last Updated: August 28, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)