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

NCT05928078 | Not Yet Recruiting

• 1 other identifier: PI22/00878 PI22/00878
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Decline

Outcome Measures

Primary Outcomes (2)

• Cognitive decline

  Using the Minimental State Examination (MMSE) for global function

  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)

  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

  Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase

• Change in Depression, anxiety and stress

  Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase

• Change in Psychological well-being

  Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase

• Change in Physical activity

  Baseline and at the end of the 12 weeks intervention in the 2nd phase

• Change in Physical function

  Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase

Study Arms (2)

Control

NO INTERVENTION

Participants will develop their usual activity

Intervention

EXPERIMENTAL

Participants will use the e-Health platform

Behavioral: intervention

Interventions

intervention 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.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Related Publications (1)

• 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.

  PMID: 38186705 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Methods

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Celia Alvarez-Bueno, PhD

CONTACT

+34625729642; celia.alvarezbueno@uclm.es

Ivan Cavero-Redondo, PhD

CONTACT

+34675568830; Ivan.Cavero@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 3, 2023
• Study Start: September 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05