Cognitive DeclineMOVI-ageingNCT05928078
A Home-based e-Health Intervention in the Elderly: MOVI-ageing
A study testing intervention in people with Cognitive Decline, run by University of Castilla-La Mancha.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read more
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.
Read the 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
- Conditions
- Cognitive Decline
- Being tested
- intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will develop their usual activity |
| Intervention | Experimental | Participants will use the e-Health platform Receives: Behavioral: intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive decline
Using the Minimental State Examination (MMSE) for global function
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in cardiorespiratory fitness
6 minutes walking test (6MWT)
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary outcomes (29)
Change in Health-related quality of life
SF-12 test
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Depression, anxiety and stress
Yesavage's 15-item GDS questionnaire
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Psychological well-being
Scale proposed by Ryff and translated and validated in Spanish by Diaz et al
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Physical activity
Axivity 6axes accelerometers (Axivity LTd. ) for seven consecutive days
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Physical function
Short Portable Physical Battery scale
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Concern about falls
Falls Efficacy Scale International (FES-I)
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Weight
the mean of two measurements (using a scale (Seca® 861) with the participant barefoot and lightly clothed.
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
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.
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Body mass index (BMI)
as weight (kg)/height2 (m2).
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
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.
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Body fat percentage
the mean of two measurements using an eight-electrode Tanita® Segmental-418 bioimpedance system (Tanita Corp.
Tokyo, Japan).
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Body composition by densitometry
With the DXA
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
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).
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Pulse wave velocity
with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
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.
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Endothelial function
with the ENDO-PAT.
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in 24-hour blood pressure
with the MAPA Mobil-O-graph.
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
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.
Measured: At baseline of the 12 weeks intervention in the 2nd phase
Change in Adherence to the Mediterranean diet
with the Mediterranean Diet Adherence Screener (MEDAS) questionnaire
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Sleep habits and quality of sleep
with the Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Comorbidities
with the Charlson comorbidity index.
Measured: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Change in Attention
Using the Flanker Task test
Measured: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Change in Working memory
Using the AWMA (Automated Working Memory Assessment) test
Measured: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Change in Cognitive flexibility
Using the DCCS (Dimension Change Card Sort) test
Measured: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Change in radial augmentation rate (rAIx)
with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in central augmentation rate (cAIx)
with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
apolipoproteins A1 and B
with the Abbott® Cobas 8000 Roche Diagnostics® system.
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
insulin ultrasensitive protein C
with the Abbott® Cobas 8000 Roche Diagnostics® system.
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)
with the Abbott® Cobas 8000 Roche Diagnostics® system.
Measured: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CELIA ÁLVAREZ BUENO, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928078
- Sponsor's protocol ID
- PI22/00878 PI22/00878
- Acronym
- MOVI-ageing
- Status last verified
- May 2024
- First submitted
- 12 Jun 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alvarez-Bueno C, Luceron-Lucas-Torres M, Ruiz-Hermosa A, Sequi-Dominguez I, Venegas-Sanabria LC, Medrano-Echeverria M, Visier-Alfonso ME, Rodriguez-Martin B. Protocol of the MOVI-ageing randomized controlled trial: a home-based e-Health intervention of cognitively demanding exercise for the improvement of cardiorespiratory fitness and cognitive function in older individuals. Front Public Health. 2023 Dec 22;11:1298316. doi: 10.3389/fpubh.2023.1298316. eCollection 2023.
PubMed 38186705
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05928078
- Acronym / sponsor ID
- MOVI-ageing / PI22/00878 PI22/00878
- Conditions
- Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jul 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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will develop their usual activity |
| Intervention | Experimental | Behavioral: interventionParticipants will use the e-Health platform |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
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 |
|---|---|---|
| interventionParticipants 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. | Behavioural | Intervention |
Primary outcome
Cognitive decline
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Using the Minimental State Examination (MMSE) for global function
Change in cardiorespiratory fitness
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
6 minutes walking test (6MWT)
29 secondary outcomes
Change in Health-related quality of life
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Depression, anxiety and stress
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Psychological well-being
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Physical activity
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Physical function
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Concern about falls
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Weight
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Height
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Body mass index (BMI)
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Waist circumference
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Body fat percentage
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Body composition by densitometry
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in HbA1c
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Pulse wave velocity
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Fasting plasma glucose, apolipoproteins A1 and B, insulin ultrasensitive protein C and endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Endothelial function
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in 24-hour blood pressure
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Educational level
Time frame: At baseline of the 12 weeks intervention in the 2nd phase
Change in Adherence to the Mediterranean diet
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Sleep habits and quality of sleep
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Comorbidities
Time frame: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Change in Attention
Time frame: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Change in Working memory
Time frame: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Change in Cognitive flexibility
Time frame: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Change in radial augmentation rate (rAIx)
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in central augmentation rate (cAIx)
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
apolipoproteins A1 and B
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
insulin ultrasensitive protein C
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 38186705Alvarez-Bueno C, Luceron-Lucas-Torres M, Ruiz-Hermosa A, Sequi-Dominguez I, Venegas-Sanabria LC, Medrano-Echeverria M, Visier-Alfonso ME, Rodriguez-Martin B. Protocol of the MOVI-ageing randomized controlled trial: a home-based e-Health intervention of cognitively demanding exercise for the improvement of cardiorespiratory fitness and cognitive function in older individuals. Front Public Health. 2023 Dec 22;11:1298316. doi: 10.3389/fpubh.2023.1298316. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing intervention in people with Cognitive Decline, run by University of Castilla-La Mancha.
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 7 inclusion and 12 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Celia Alvarez-Bueno, PhD (+34625729642, celia.alvarezbueno@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive decline (time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase). 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?
On the ClinicalTrials.gov record for NCT05928078, which also lists 1 linked publication.
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 8 May 2024.