Effectiveness of a High-intensity Interval Exercise Program in People With Alzheimer's

NCT05691842 | Unknown

• 1 other identifier: 1686728
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease (AD) is a the most common type of dementia. It is a progressive disease that affects different areas of human behavior at the cognitive, social, physical and metabolic levels. The benefits of a High-Intensity Interval Exercise Program (HIIT) has been proven not only in healthy older adults, but also in different pathologies, such as cerebrovascular and cardiometabolic diseases. However, there are no studies to date that examine the impact of HIIT in people with AD. The aim of this study was to ascertain the effectiveness of a HIIT program versus a cognitive and motor dual task balance program on parameters related to functional capacity and cognitive function in people with AD.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline cardiorespiratory fitness

  6 minutes walking test" (6MWT): distance (m)

  At baseline, immediately after the intervention and at 2 month-follow-up

• Change from baseline balance ability

  Star Excursion Balance Test: maximal distance in all directions (cm), 3 times

  At baseline, post-intervention and at 2 month-follow-up

Secondary Outcomes (8)

• Change from baseline lower limb isometric strength

  At baseline, immediately after the intervention and at 2 month-follow-up

• Change from baseline lower limb power

  At baseline, immediately after the intervention and at 2 month-follow-up

• Change from baseline Risk of Falling

  At baseline, immediately after the intervention and at 2 month-follow-up

• Fall frequency

  Daily for 12 weeks (the length of the intervention)

• Change from baseline Fear of falling

  At baseline, immediately after the intervention and at 2 month-follow-up

Study Arms (3)

HIIT intervention

EXPERIMENTAL

Patients in this group (n=22) will undergo a HIIT training protocol for 12 weeks

Other: HIIT intervention

Dual task intervention (DT)

EXPERIMENTAL

Patients in this group (n=22) will undergo a DT training protocol for 12 weeks

Other: Dual task intervention

Control group (CG)

NO INTERVENTION

Patients in this group (n=22) will not perform any exercise during the intervention period (12 weeks)

Interventions

HIIT intervention OTHER

Patients will perform a muscle strength training circuit interspersed with resistance training circuit. The strength training circuit will consist of 10 strength exercises and resistance training circuit will consist of walking, jogging and running exercises. Each exercise will be performed for one minute, trying to reach maximum intensities adapted to each individual's condition.

HIIT intervention

Dual task intervention OTHER

Dual task training will consist of the progressive and specific assignment of primary motor tasks and secondary motor or cognitive tasks focused on: i) Primary tasks: static, dynamic balance and gait exercises; ii) Secondary tasks (motor or cognitive): verbal fluency, mathematical calculation, memory, visual-spatial planning, auditory discrimination, fine motor task, motor transport task.

Dual task intervention (DT)

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 60 -90 years
• Diagnosed with mild or moderate AD according to the Clinical Dementia Rating (CDR1).
• Ability to follow the instructions of the training program.
• Ability to get up from a chair alone.
• Independent ambulation.
• Providing signed informed consent.

You may not qualify if:

• Dementia or severe cognitive impairment that makes it impossible to understand instructions.
• Presence of other neurological pathologies such as: stroke, Parkinson's or cranioencephalic trauma.
• Severe cardiovascular disorders.
• Severe visual deficits.
• Vertigo
• Other limitations that make it difficult to ambulate.
• Participating in any high intensity exercise program.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy, University of Valencia

Valencia, 46022, Spain

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Marta Inglés, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Inglés, PhD

CONTACT

(+34) 96 398 38 55; marta.ingles@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: January 20, 2023
• Study Start: December 20, 2022
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 20, 2023

Record last verified: 2022-11

Locations

ES (1)