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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
50
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.
Cognitive decline
Using the Minimental State Examination (MMSE) for global function
Time frame: 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)
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Health-related quality of life
SF-12 test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Physical function
Short Portable Physical Battery scale
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: 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).
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)
with the Abbott® Cobas 8000 Roche Diagnostics® system.
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
Change in Endothelial function
with the ENDO-PAT.
Time frame: 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.
Time frame: 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.
Time frame: 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
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
with the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Change in Comorbidities
with the Charlson comorbidity index.
Time frame: At baseline of the 12 weeks intervention in the 2nd and 3rd phase
Change in Attention
Using the Flanker Task test
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
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)
with the Abbott® Cobas 8000 Roche Diagnostics® system.
Time frame: Baseline and at the end of the 12 weeks intervention in the 2nd phase
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