Clinical trial NCT05928078: A Home-based e-Health Intervention in the Elderly: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Decline
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Cognitive decline
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in cardiorespiratory fitness
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary outcomes:
measure: Change in Health-related quality of life
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Depression, anxiety and stress
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Psychological well-being
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Physical activity
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: Change in Physical function
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Concern about falls
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Weight
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Height
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Body mass index (BMI)
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Waist circumference
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Body fat percentage
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Body composition by densitometry
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: Change in HbA1c
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: Change in Pulse wave velocity
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: Change in Fasting plasma glucose, apolipoproteins A1 and B, insulin ultrasensitive protein C and endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: Change in Endothelial function
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: Change in 24-hour blood pressure
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: Change in Educational level
timeFrame: At baseline of the 12 weeks intervention in the 2nd phase
measure: Change in Adherence to the Mediterranean diet
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Sleep habits and quality of sleep
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Comorbidities
timeFrame: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Attention
timeFrame: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Working memory
timeFrame: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in Cognitive flexibility
timeFrame: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
measure: Change in radial augmentation rate (rAIx)
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: Change in central augmentation rate (cAIx)
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: apolipoproteins A1 and B
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: insulin ultrasensitive protein C
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
measure: endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)
timeFrame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Other outcomes:
Locations:
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