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A Home-based e-Health Intervention in the Elderly: MOVI-ageing (MOVI-ageing)

Primary Purpose

Cognitive Decline

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intervention
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: are 60 years of age or older of both genders; are retired regardless of the reason for retirement; do not meet frailty criteria according to Fried criteria; without disabilities for activities of daily living; living independently; without cognitive impairment as determined by the Mini-Mental test greater than 24 (considering the degree of schooling of the participants); able to walk at least 20 meters with or without walking aids. Exclusion Criteria: mobility problem; serious health problem (e.g., recent myocardial infarction, recent heart attack, etc.). recent myocardial infarction, uncontrolled diabetes or uncontrolled hypertension); orthopedic or neurological disease that prevents training; Alzheimer's disease or dementia; progressive or terminal terminal illness; acute or chronic illness; history of heart attack; history of vertigo or recent head injury; health problems that may affect the ability to perform the EF programs (e.g. acute and painful joint inflammation, impaired mobility after a stroke), or any unstable health condition; use of medications that act at the neuron level (e.g., psychotropic medications); signs of incipient depression; pathology that makes it difficult to use the computer application through which the FE program will be developed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Participants will develop their usual activity

    Participants will use the e-Health platform

    Outcomes

    Primary Outcome Measures

    Cognitive decline
    Using the Minimental State Examination (MMSE) for global function
    Change in cardiorespiratory fitness
    6 minutes walking test (6MWT)

    Secondary Outcome Measures

    Change in Health-related quality of life
    SF-12 test
    Change in Depression, anxiety and stress
    Yesavage's 15-item GDS questionnaire
    Change in Psychological well-being
    Scale proposed by Ryff and translated and validated in Spanish by Diaz et al
    Change in Physical activity
    Axivity 6axes accelerometers (Axivity LTd. ) for seven consecutive days
    Change in Physical function
    Short Portable Physical Battery scale
    Change in Concern about falls
    Falls Efficacy Scale International (FES-I)
    Change in Weight
    the mean of two measurements (using a scale (Seca® 861) with the participant barefoot and lightly clothed.
    Change in Height
    the mean of two measurements with a wall-mounted stadiometer (Seca® 222), with the participant barefoot and in an upright position while the sagittal midline of the back touches the vertical bar.
    Change in Body mass index (BMI)
    as weight (kg)/height2 (m2).
    Change in Waist circumference
    the mean of three measurements using a flexible tape measure at the midpoint between the last rib and the iliac crest at the end of a normal exhalation.
    Change in Body fat percentage
    the mean of two measurements using an eight-electrode Tanita® Segmental-418 bioimpedance system (Tanita Corp. Tokyo, Japan).
    Change in Body composition by densitometry
    With the DXA
    Change in HbA1c
    using the ADAMS A1c HA-8180V analyzer (Menarini Diagnostics®), a method certified by the NGSP (National Glycohemoglobin Standardization Program) and the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine).
    Change in Pulse wave velocity
    with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).
    Change in Fasting plasma glucose, apolipoproteins A1 and B, insulin ultrasensitive protein C and endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)
    with the Abbott® Cobas 8000 Roche Diagnostics® system.
    Change in Endothelial function
    with the ENDO-PAT.
    Change in 24-hour blood pressure
    with the MAPA Mobil-O-graph.
    Change in Educational level
    measured as the maximum level of education attained by each participant, classifying them as: cannot read or write, no studies, incomplete primary studies, primary studies, school graduate studies, higher baccalaureate studies, medium university studies, or higher university studies.
    Change in Adherence to the Mediterranean diet
    with the Mediterranean Diet Adherence Screener (MEDAS) questionnaire
    Change in Sleep habits and quality of sleep
    with the Pittsburgh Sleep Quality Index (PSQI)
    Change in Comorbidities
    with the Charlson comorbidity index.
    Change in Attention
    Using the Flanker Task test
    Change in Working memory
    Using the AWMA (Automated Working Memory Assessment) test
    Change in Cognitive flexibility
    Using the DCCS (Dimension Change Card Sort) test
    Change in radial augmentation rate (rAIx)
    with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).
    Change in central augmentation rate (cAIx)
    with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).
    apolipoproteins A1 and B
    with the Abbott® Cobas 8000 Roche Diagnostics® system.
    insulin ultrasensitive protein C
    with the Abbott® Cobas 8000 Roche Diagnostics® system.
    endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)
    with the Abbott® Cobas 8000 Roche Diagnostics® system.

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    September 21, 2023
    Sponsor
    University of Castilla-La Mancha
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05928078
    Brief Title
    A Home-based e-Health Intervention in the Elderly: MOVI-ageing
    Acronym
    MOVI-ageing
    Official Title
    A Home-based e-Health Intervention of Demanding Cognitive Exercise for the Improvement of Cardiorespiratory Fitness and Cognitive Function in the Elderly: MOVI-ageing.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Castilla-La Mancha

    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
    This protocol study aims to evaluate the efficacy of the MOVI-ageing intervention, a complex home-based eHealth intervention of cognitive-demanding exercise for the elderly, in improving: global cognitive function and basic cognitive functions and cardiorespiratory and muscular fitness. In addition, this sudy aims to evaluate the efficacy of the MOVI-ageing intervention, in improving: body composition (waist circumference and fat percentage), blood pressure, and health-related quality of life. The MOVI-ageing project has been designed in three phases comprising: i) a tool development study; ii) a 12-week randomized efficacy/feasibility trial of the intervention; and iii), a large-scale implementation phase with a 12-week randomized trial. The investigators will use a qualitative approach to improve the plataform design with the users perspective. Participants will have access to a platform where participants will be able to view videos of cognitively demanding physical exercise programs. The videos will be directed by an avatar and the research staff will be able to know the degree of compliance with the program and the correct execution of the program through the use of Physio Galenus technology. The platform will have information on how to be more active, and chat lines to communicate with the research group. Participants will receive feedback on their compliance with the routines and reinforcement messages.
    Detailed Description
    This study will be carried out in three phases. During the first phase, the research team will conduct a literature review and focus groups to implement in the development of the online platform the information available in the scientific evidence and the needs and expectations of the people who will use it. The second phase will include the implementation of the platform and its piloting in a small sample of the population. This second phase will allow the researchers to improve the platform and its access based on the results and user experiences. During the third phase the platform will be made accessible to a larger population group to show its effect on improving cognitive function and cardiorespiratory fitness in the elderly

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants will develop their usual activity
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Participants will use the e-Health platform
    Intervention Type
    Behavioral
    Intervention Name(s)
    intervention
    Intervention Description
    Participants will be required to use the MOVI-ageing platform 3 times a week for 12 weeks. The platform will include videos of cognitively demanding physical activities designed and guided by health professionals, who will also be able to check compliance with the intervention.
    Primary Outcome Measure Information:
    Title
    Cognitive decline
    Description
    Using the Minimental State Examination (MMSE) for global function
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in cardiorespiratory fitness
    Description
    6 minutes walking test (6MWT)
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Secondary Outcome Measure Information:
    Title
    Change in Health-related quality of life
    Description
    SF-12 test
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Depression, anxiety and stress
    Description
    Yesavage's 15-item GDS questionnaire
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Psychological well-being
    Description
    Scale proposed by Ryff and translated and validated in Spanish by Diaz et al
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Physical activity
    Description
    Axivity 6axes accelerometers (Axivity LTd. ) for seven consecutive days
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    Change in Physical function
    Description
    Short Portable Physical Battery scale
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Concern about falls
    Description
    Falls Efficacy Scale International (FES-I)
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Weight
    Description
    the mean of two measurements (using a scale (Seca® 861) with the participant barefoot and lightly clothed.
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Height
    Description
    the mean of two measurements with a wall-mounted stadiometer (Seca® 222), with the participant barefoot and in an upright position while the sagittal midline of the back touches the vertical bar.
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Body mass index (BMI)
    Description
    as weight (kg)/height2 (m2).
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Waist circumference
    Description
    the mean of three measurements using a flexible tape measure at the midpoint between the last rib and the iliac crest at the end of a normal exhalation.
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Body fat percentage
    Description
    the mean of two measurements using an eight-electrode Tanita® Segmental-418 bioimpedance system (Tanita Corp. Tokyo, Japan).
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Body composition by densitometry
    Description
    With the DXA
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    Change in HbA1c
    Description
    using the ADAMS A1c HA-8180V analyzer (Menarini Diagnostics®), a method certified by the NGSP (National Glycohemoglobin Standardization Program) and the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine).
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    Change in Pulse wave velocity
    Description
    with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    Change in Fasting plasma glucose, apolipoproteins A1 and B, insulin ultrasensitive protein C and endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)
    Description
    with the Abbott® Cobas 8000 Roche Diagnostics® system.
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    Change in Endothelial function
    Description
    with the ENDO-PAT.
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    Change in 24-hour blood pressure
    Description
    with the MAPA Mobil-O-graph.
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    Change in Educational level
    Description
    measured as the maximum level of education attained by each participant, classifying them as: cannot read or write, no studies, incomplete primary studies, primary studies, school graduate studies, higher baccalaureate studies, medium university studies, or higher university studies.
    Time Frame
    At baseline of the 12 weeks intervention in the 2nd phase
    Title
    Change in Adherence to the Mediterranean diet
    Description
    with the Mediterranean Diet Adherence Screener (MEDAS) questionnaire
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Sleep habits and quality of sleep
    Description
    with the Pittsburgh Sleep Quality Index (PSQI)
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Comorbidities
    Description
    with the Charlson comorbidity index.
    Time Frame
    At baseline of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Attention
    Description
    Using the Flanker Task test
    Time Frame
    At baseline of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Working memory
    Description
    Using the AWMA (Automated Working Memory Assessment) test
    Time Frame
    At baseline of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in Cognitive flexibility
    Description
    Using the DCCS (Dimension Change Card Sort) test
    Time Frame
    At baseline of the 12 weeks intervention in the 2nd and 3rd phase
    Title
    Change in radial augmentation rate (rAIx)
    Description
    with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    Change in central augmentation rate (cAIx)
    Description
    with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    apolipoproteins A1 and B
    Description
    with the Abbott® Cobas 8000 Roche Diagnostics® system.
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    insulin ultrasensitive protein C
    Description
    with the Abbott® Cobas 8000 Roche Diagnostics® system.
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase
    Title
    endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)
    Description
    with the Abbott® Cobas 8000 Roche Diagnostics® system.
    Time Frame
    Baseline and at the end of the 12 weeks intervention in the 2nd phase

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: are 60 years of age or older of both genders; are retired regardless of the reason for retirement; do not meet frailty criteria according to Fried criteria; without disabilities for activities of daily living; living independently; without cognitive impairment as determined by the Mini-Mental test greater than 24 (considering the degree of schooling of the participants); able to walk at least 20 meters with or without walking aids. Exclusion Criteria: mobility problem; serious health problem (e.g., recent myocardial infarction, recent heart attack, etc.). recent myocardial infarction, uncontrolled diabetes or uncontrolled hypertension); orthopedic or neurological disease that prevents training; Alzheimer's disease or dementia; progressive or terminal terminal illness; acute or chronic illness; history of heart attack; history of vertigo or recent head injury; health problems that may affect the ability to perform the EF programs (e.g. acute and painful joint inflammation, impaired mobility after a stroke), or any unstable health condition; use of medications that act at the neuron level (e.g., psychotropic medications); signs of incipient depression; pathology that makes it difficult to use the computer application through which the FE program will be developed.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Celia Alvarez-Bueno, PhD
    Phone
    +34625729642
    Email
    celia.alvarezbueno@uclm.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ivan Cavero-Redondo, PhD
    Phone
    +34675568830
    Email
    Ivan.Cavero@uclm.es

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Home-based e-Health Intervention in the Elderly: MOVI-ageing

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