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

Cognitive Decline Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05928078
• Other study ID #: PI22/00878 PI22/00878
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Castilla-La Mancha
• Contact: Celia Alvarez-Bueno, PhD
• Phone: +34625729642
• Email: celia.alvarezbueno[@]uclm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Health-related quality of life	SF-12 test	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Depression, anxiety and stress	Yesavage's 15-item GDS questionnaire	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Psychological well-being	Scale proposed by Ryff and translated and validated in Spanish by Diaz et al	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Physical activity	Axivity 6axes accelerometers (Axivity LTd. ) for seven consecutive days	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	Change in Physical function	Short Portable Physical Battery scale	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Concern about falls	Falls Efficacy Scale International (FES-I)	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Weight	the mean of two measurements (using a scale (Seca® 861) with the participant barefoot and lightly clothed.	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	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.	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Body mass index (BMI)	as weight (kg)/height2 (m2).	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	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.	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Body fat percentage	the mean of two measurements using an eight-electrode Tanita® Segmental-418 bioimpedance system (Tanita Corp.; Tokyo, Japan).	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Body composition by densitometry	With the DXA	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	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).	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	Change in Pulse wave velocity	with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	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.	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	Change in Endothelial function	with the ENDO-PAT.	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	Change in 24-hour blood pressure	with the MAPA Mobil-O-graph.	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	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.	At baseline of the 12 weeks intervention in the 2nd phase
Secondary	Change in Adherence to the Mediterranean diet	with the Mediterranean Diet Adherence Screener (MEDAS) questionnaire	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Sleep habits and quality of sleep	with the Pittsburgh Sleep Quality Index (PSQI)	Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Comorbidities	with the Charlson comorbidity index.	At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Attention	Using the Flanker Task test	At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Working memory	Using the AWMA (Automated Working Memory Assessment) test	At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in Cognitive flexibility	Using the DCCS (Dimension Change Card Sort) test	At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Secondary	Change in radial augmentation rate (rAIx)	with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	Change in central augmentation rate (cAIx)	with the SphygmoCor system (AtCor Medical Pty Ltd Head Office, West Ryde, Australia).	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	apolipoproteins A1 and B	with the Abbott® Cobas 8000 Roche Diagnostics® system.	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	insulin ultrasensitive protein C	with the Abbott® Cobas 8000 Roche Diagnostics® system.	Baseline and at the end of the 12 weeks intervention in the 2nd phase
Secondary	endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)	with the Abbott® Cobas 8000 Roche Diagnostics® system.	Baseline and at the end of the 12 weeks intervention in the 2nd phase