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

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
HIIT intervention
Dual task intervention
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physiotherapy, University of ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

HIIT intervention

Dual task intervention (DT)

Control group (CG)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline cardiorespiratory fitness
6 minutes walking test" (6MWT): distance (m)
Change from baseline balance ability
Star Excursion Balance Test: maximal distance in all directions (cm), 3 times

Secondary Outcome Measures

Change from baseline lower limb isometric strength
Lafyette dynamometer: quadriceps, hamstrings, gastrocnemius,tibialis anterior
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
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
Fall frequency
Fall diary. The individual is asked to write down how many times he/she falls during a period.
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)
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.
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.
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.

Full Information

First Posted
November 18, 2022
Last Updated
January 16, 2023
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05691842
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIIT intervention
Arm Type
Experimental
Arm Description
Patients in this group (n=22) will undergo a HIIT training protocol for 12 weeks
Arm Title
Dual task intervention (DT)
Arm Type
Experimental
Arm Description
Patients in this group (n=22) will undergo a DT training protocol for 12 weeks
Arm Title
Control group (CG)
Arm Type
No Intervention
Arm Description
Patients in this group (n=22) will not perform any exercise during the intervention period (12 weeks)
Intervention Type
Other
Intervention Name(s)
HIIT intervention
Intervention Description
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
Intervention Name(s)
Dual task intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline cardiorespiratory fitness
Description
6 minutes walking test" (6MWT): distance (m)
Time Frame
At baseline, immediately after the intervention and at 2 month-follow-up
Title
Change from baseline balance ability
Description
Star Excursion Balance Test: maximal distance in all directions (cm), 3 times
Time Frame
At baseline, post-intervention and at 2 month-follow-up
Secondary Outcome Measure Information:
Title
Change from baseline lower limb isometric strength
Description
Lafyette dynamometer: quadriceps, hamstrings, gastrocnemius,tibialis anterior
Time Frame
At baseline, immediately after the intervention and at 2 month-follow-up
Title
Change from baseline lower limb power
Description
30 Second Sit to Stand Test: number of times the patient comes to a full standing position in 30 seconds
Time Frame
At baseline, immediately after the intervention and at 2 month-follow-up
Title
Change from baseline Risk of Falling
Description
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
Time Frame
At baseline, immediately after the intervention and at 2 month-follow-up
Title
Fall frequency
Description
Fall diary. The individual is asked to write down how many times he/she falls during a period.
Time Frame
Daily for 12 weeks (the length of the intervention)
Title
Change from baseline Fear of falling
Description
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)
Time Frame
At baseline, immediately after the intervention and at 2 month-follow-up
Title
Change from baseline Cognitive status
Description
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.
Time Frame
At baseline, immediately after the intervention and at 2 month-follow-up
Title
Change from baseline Executive function status
Description
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.
Time Frame
At baseline, immediately after the intervention and at 2 month-follow-up
Title
Change from baseline depression levels
Description
Geriatric Depression Scale (15-item scale): This scale is scored form 0 to 15. A score higher than 5 points suggests depression.
Time Frame
At baseline, immediately after the intervention and at 2 month-follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Inglés, PhD
Phone
(+34) 96 398 38 55
Email
marta.ingles@uv.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Inglés, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physiotherapy, University of Valencia
City
Valencia
ZIP/Postal Code
46022
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Inglés, PhD
Phone
(+34) 96 398 38 55

12. IPD Sharing Statement

Learn more about this trial

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

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