Introduction: The progressive aging of the population is a socio-demographic phenomenon experienced by most countries in the world in recent decades, especially in Japan and in many European Union countries. During this process, so-called "geriatric syndromes" frequently occur. The focus of this study is the quality of life of the elderly in relation to these three factors: risk of falls, urinary incontinence, and insomnia. Objective: The main purpose is to determine the impact of a multifactorial intervention program implemented with institutionalized elderly people. The program is focused on the treatment of the aforementioned factors. Methods and Analysis: The study will be carried out with elderly people living in three residences for the elderly in A Coruña Province (Galicia, Spain). It is a prospective and longitudinal study, with a temporary series design of a "quasi-experimental" type that evaluates the effect of an intervention in one given population by doing assessments pre- and post-intervention, but there is no comparison with a control group. The intervention will be based on a multifactorial program, including the following phases: the use of wearable devices (wearable fitness trackers to register physical activity and sleep), the use of an App on a Tablet to record the participants' occupations and activities, counseling about performance in activities of daily living, the implementation of a physical activity program, and the treatment of the pelvic floor (according to each research line). The Quality of Life (QoL) will be assessed before and after the intervention, with the use of the questionnaire EuroQol-5D-5L. Data analysis will be applied with all registered variables through a quantitative perspective.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
57
To implement this line, the protocol of the VIVIFRAIL Project will be used as a reference. That protocol has different physical exercises, divided into itineraries, in order to adapt it to a person's capability. Several sessions of this research line will employ the use of videogames so that the elderly can explore new forms of physical activity and thus establish contact and expertise with new technologies. It is estimated that two sessions per week over two months are needed for each person to continue doing physical activity independently and with autonomy.
Will take place with those participants who are included in the research lines of insomnia and risk of falls. It is estimated that two sessions per week for one month are needed.
the intervention will apply to participants enrolled in the research line dealing with urinary incontinence during the six months of intervention, with a frequency of two sessions per week
After the physical activity and relaxation programs, the counselling will start. With each participant, routines and daily activities will be planned that will be adequate according to different recommendations about urinary incontinence, insomnia and risk of falls. Different performance guidelines will be established in order to establish a good balance between activities. The guidelines can include the recommendations about adjustments to the environment. It is estimated that three sessions per week for two months are needed to incorporate advice and routines into the daily lives of participants.
Universidade da Coruña
A Coruña, Spain
Changes in the quality of life
The variable will be determined with EuroQol-5D-5L. This descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Independence on Activities of Daily Living
Barthel Activities of Daily Living (ADL) Index: This tool is used as a simple index of independence to score the ability of a patient to care for himself, and by repeating the test periodically, to assess his improvement. The performance is assessed based on these scores: \<20: total dependence, 20---40: severe dependence, 45-55: moderate dependence, and 60 or more: mild dependence.
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Gait and balance
The test is scored on the individual's ability to perform specific tasks. "Scoring of the Tinetti Assessment Tool is done on a three-point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score (12 points), an overall balance assessment score (16 points), and a combined gait and balance score (28).
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Cognitive State
Mini-Mental State Examination (MMSE): This tool has been designed to determine the "cognitive state," that is one of the study's variables. It presents six values: one for each section (Orientation, Fixation, Concentration and calculation, Memory and Language, and Construction)
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Oxford Grading Scale
This scale measures the variable of "pelvic floor contractile capacity". It has a unique numerical value (0-5), that is the result from assessment of the contractile capacity of the pelvic floor muscles
Time frame: Baseline and 3 months after intervention
Sandvick Severity Index
This test assesses the variable "urine leakage". It presents a unique numerical value and consists of two questions, one of them about the frequency with which a person has urine leakage (maximum score of 4 points) and another with reference to the amount of urine in the exhaust (maximum score of 3 points)
Time frame: Baseline and 3 months after intervention
24-Hour Pad Test
This tool allows to measure the "amount of urine". This scale has three values (net weight of the napkin/diaper, weight with urine and weight difference).
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Pelvic Floor Muscle Assessment: PERFECT Scheme
The tool PERFECT Scheme allows to assess the "pelvic floor musculature". PERFECT is an acronym with P representing power (or pressure, a measure of strength using a manometric perineometer), E = endurance, R = repetitions, F = fast contractions, and ECT = every contraction timed.
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
International Consultation on Incontinence Questionnaire (Short Form)
Self-administered questionnaire that qualifies the "symptoms and quality of life" in both male and female adult patients with symptoms of urine loss. It has 6 items, Score is 0 - 21 with a higher score indicating greater severity.
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Oviedo Sleep Questionnaire
This scale allows assess the "sleep satisfaction". It consists of 13 items with three values: one for each section (sleep satisfaction, insomnia and hypersomnia). Each item is scored from 1 to 5, except for item 1 which is scored from 1 to 7. The subscale of insomnia ranges from 9 to 45 points; the higher the score the greater the severity.
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Pittsburgh Sleep Quality Assessment
The measure consists of 19 individual items, creating seven components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Timed Get Up and Go Test
A simple test used to assess a person's mobility and requires both static and dynamic balance
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Falls Efficacy Scale International
The tool measures "the level of concern about falling" during social and physical activities inside and outside the home. Individuals are asked to rate, on a four-point Likert scale,their concerns aboutthe possibility offalling when performing 16 activities.The scores are added up to calculate a total score that ranges from 16 to 64 for the FES-I and 8 to 28 for the short FES-I. A higher score indicates a greater fear of falls
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
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