Clinical trial NCT05691842: Effectiveness of a High-intensity Interval Exercise Program in People With Alzheimer's
Official title: Efficacy of a High-Intensity Interval Exercise Program Versus a Dual-Task Training Program in People With Alzheimer's: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline cardiorespiratory fitness
timeFrame: At baseline, immediately after the intervention and at 2 month-follow-up
measure: Change from baseline balance ability
timeFrame: At baseline, post-intervention and at 2 month-follow-up
Secondary outcomes:
measure: Change from baseline lower limb isometric strength
timeFrame: At baseline, immediately after the intervention and at 2 month-follow-up
measure: Change from baseline lower limb power
timeFrame: At baseline, immediately after the intervention and at 2 month-follow-up
measure: Change from baseline Risk of Falling
timeFrame: At baseline, immediately after the intervention and at 2 month-follow-up
measure: Fall frequency
timeFrame: Daily for 12 weeks (the length of the intervention)
measure: Change from baseline Fear of falling
timeFrame: At baseline, immediately after the intervention and at 2 month-follow-up
measure: Change from baseline Cognitive status
timeFrame: At baseline, immediately after the intervention and at 2 month-follow-up
measure: Change from baseline Executive function status
timeFrame: At baseline, immediately after the intervention and at 2 month-follow-up
measure: Change from baseline depression levels
timeFrame: At baseline, immediately after the intervention and at 2 month-follow-up
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy, University of Valencia
Study officials:
affiliation: University of Valencia
name: Marta Inglés, PhD
role: PRINCIPAL_INVESTIGATOR
References: