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

NCT ID: NCT05691842

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2026-01-31

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.

Detailed Description

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 interventions such as dual-task training (TD) have been the focus of studies in recent years in AD. Current evidence shows that DT training leads to improvements in parameters related to frontal cognitive function, such as: planning, organization, strategy creation, abstraction, motor sequencing, working memory, thinking flexibility, visual search, sequencing, sustained attention and working memory. DT training has been also shown to improve variables related to gait ability and balance, such as step length and gait speed, postural control and specific functional tasks under challenging conditions of double task. However, AD is also associated with reduced cardiovascular fitness and decreased muscle strength, thus leading to a loss of independence in activities of daily living and poor quality of life.

A promising intervention to address these issues is high-intensity interval exercise (HIIT), defined as brief intermittent bursts of vigorous activity interspersed with periods of rest or low-intensity exercise. Indeed, it has been reported that HIIT generates greater benefits in cardiorespiratory capacity and greater metabolic adaptations than continuous exercise of moderate intensity in healthy older adults. HIIT interventions have resulted in benefits on variables related to functional capacity, such as improved gait speed, increased muscle mass and strength. Furthermore, HIIT has been shown to improve variables related to cognitive function, such as attention, perception and memory abilities.

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.

Therefore, a randomized clinical trial will be carried out, in which three groups of twenty people in each group will participate, with different interventions:

• Experimental group 1: HIIT (HIIT)
• Experimental group 2: Dual task training (DT)
• Control group: No intervention (CG) Participants will be evaluated in three moments, at baseline (T1), post-intervention (T2) and at 2 month-follow-up (T3).

Data analysis will be performed with SPSS statistic program (v26). Normality and homoscedasticity will be analyzed by Shapiro-Wilk t-test and Levene test, respectively. For comparation between groups Bonferroni will be used. If any confusion factor that not meet requirements to be analysed like a covariable exist, ANCOVA will be used. When p<0.0.5 statistical significant differences will be assumed.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HIIT intervention

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

Group Type: EXPERIMENTAL

HIIT intervention

Intervention Type: 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.

Dual task intervention (DT)

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

Group Type: EXPERIMENTAL

Dual task intervention

Intervention Type: 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.

Control group (CG)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HIIT intervention

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.

Intervention Type: OTHER

Dual task intervention

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marta Inglés, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

Faculty of Physiotherapy, University of Valencia

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Marta Inglés, PhD

Role: CONTACT

marta.ingles@uv.es

(+34) 96 398 38 55

Facility Contacts

Marta Inglés, PhD

Role: primary

(+34) 96 398 38 55

Other Identifiers

1686728

Identifier Type: -

Identifier Source: org_study_id