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

NCT ID: NCT05928078

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-12-31

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

Conditions

Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control

Participants will develop their usual activity

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants will use the e-Health platform

Group Type: EXPERIMENTAL

intervention

Intervention Type: BEHAVIORAL

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.

Interventions

intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

CELIA ÁLVAREZ BUENO

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Celia Alvarez-Bueno, PhD

Role: CONTACT

celia.alvarezbueno@uclm.es

+34625729642

Ivan Cavero-Redondo, PhD

Role: CONTACT

Ivan.Cavero@uclm.es

+34675568830

References

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.

Reference Type: DERIVED

PMID: 38186705 (View on PubMed)

Other Identifiers

PI22/00878 PI22/00878

Identifier Type: -

Identifier Source: org_study_id