Alzheimer DiseaseNCT05691842
Effectiveness of a High-intensity Interval Exercise Program in People With Alzheimer's
A study testing HIIT intervention and Dual task intervention in people with Alzheimer Disease, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- HIIT intervention and Dual task intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2022to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Physiotherapy, University of Valencia
Valencia, 46022
Marta Inglés, PhD, (+34) 96 398 38 55
About this study
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
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.
Read the 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
- Being tested
- HIIT intervention, Dual task intervention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT interventionOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HIIT intervention | Experimental | Patients in this group (n=22) will undergo a HIIT training protocol for 12 weeks Receives: Other: HIIT intervention |
| Dual task intervention (DT) | Experimental | Patients in this group (n=22) will undergo a DT training protocol for 12 weeks Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline cardiorespiratory fitness
6 minutes walking test" (6MWT): distance (m)
Measured: 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
Measured: At baseline, post-intervention and at 2 month-follow-up
Secondary outcomes (8)
Change from baseline lower limb isometric strength
Lafyette dynamometer: quadriceps, hamstrings, gastrocnemius,tibialis anterior
Measured: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline lower limb power
30 Second Sit to Stand Test: number of times the patient comes to a full standing position in 30 seconds
Measured: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline Risk of Falling
Timed up and go: time (in seconds) that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling
Measured: At baseline, immediately after the intervention and at 2 month-follow-up
Fall frequency
Fall diary. The individual is asked to write down how many times he/she falls during a period.
Measured: Daily for 12 weeks (the length of the intervention)
Change from baseline Fear of falling
Falls Eficacy Scale International. It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)
Measured: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline Cognitive status
Mini-Mental State Examination: The Mini-mental state examination is scored on a scale of 0-30 with scores > 24 interpreted as normal cognitive status.
Measured: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline Executive function status
Stroop test: Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability.
Measured: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline depression levels
Geriatric Depression Scale (15-item scale): This scale is scored form 0 to 15. A score higher than 5 points suggests depression.
Measured: At baseline, immediately after the intervention and at 2 month-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start20 Dec 2022
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Inglés, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691842
- Sponsor's protocol ID
- 1686728
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05691842
- Acronym / sponsor ID
- 1686728
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIIT intervention | Experimental | Other: HIIT interventionPatients in this group (n=22) will undergo a HIIT training protocol for 12 weeks |
| Dual task intervention (DT) | Experimental | Other: Dual task interventionPatients in this group (n=22) will undergo a DT training protocol for 12 weeks |
| Control group (CG) | No intervention | –Patients in this group (n=22) will not perform any exercise during the intervention period (12 weeks) |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT interventionPatients 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. | Other | HIIT intervention |
| Dual task interventionDual 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. | Other | Dual task intervention (DT) |
Primary outcome
Change from baseline cardiorespiratory fitness
Time frame: At baseline, immediately after the intervention and at 2 month-follow-up
6 minutes walking test" (6MWT): distance (m)
Change from baseline balance ability
Time frame: At baseline, post-intervention and at 2 month-follow-up
Star Excursion Balance Test: maximal distance in all directions (cm), 3 times
8 secondary outcomes
Change from baseline lower limb isometric strength
Time frame: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline lower limb power
Time frame: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline Risk of Falling
Time frame: At baseline, immediately after the intervention and at 2 month-follow-up
Fall frequency
Time frame: Daily for 12 weeks (the length of the intervention)
Change from baseline Fear of falling
Time frame: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline Cognitive status
Time frame: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline Executive function status
Time frame: At baseline, immediately after the intervention and at 2 month-follow-up
Change from baseline depression levels
Time frame: At baseline, immediately after the intervention and at 2 month-follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Inglés, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT intervention and Dual task intervention in people with Alzheimer Disease, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Inglés, PhD ((+34) 96 398 38 55, marta.ingles@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline cardiorespiratory fitness (time frame: At baseline, immediately after the intervention and at 2 month-follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.