Effects of Function-focused Multicomponent Physical Exercise Program. Interventional Single Group Study

Study Overview
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Brief Summary
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The purpose of this research study is to determine whether a physical exercise program in nursing homes will maintain autonomy in activities of daily living, decrease vulnerability and improve physical, psychological and cognitive condition. An individualized and progressive multi-component physical exercise program focused on function has been designed to achieve this objective. Participant will engage in an exercise program for 6 months in their nursing homes, in two sessions per week of 45-60 minutes

Detailed Description
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Primary aim: The major aim is to ascertain whether multicomponent exercise program focused on function can maintain autonomy in older adults living in nursing homes. Secondary aims: To ascertain the influence of the evaluated exercise program on frailty, physical, psycho-affective and cognitive conditions in older people living in nursing homes. Analyze if the influence that the exercise program has had on dependence, frailty, physical, psycho-affective and cognitive condition is maintained after 6 months since the end of the program Examine the influence that the exercise program has on different clinical outcomes: falls, hospitalizations, visits to emergency service, the level of dependence, etc. Design: experimental, multi-center and single-group physical exercise intervention Intervention: Combined multicomponent physical exercise program that includes strength, balance and flexibility exercises and performed in long term care homes focused on functionality on activities of daily living. The first 3 months the exercise program aims to restore the physical condition through the multicomponent exercise program. Feasibility and safety of the multicomponent exercise program were ascertained in a previous study (Arrieta et al., 2018; Rodriguez-Larrad et al., 2017). This program will comprise of upper and lower body strengthening exercises, using external weights for 2-3 sets of 8-12 repetitions at a progressive incremental intensity of 30-50% of 1Repetition Maximum (RM). In addition, static balance and flexibility exercise will be performed. From 3th to 6th months, the objective will be to improve autonomy in daily live activities through the functional exercise program. Strength exercises will be maintained with external weights and the intensity will be increased to 60-70% of 1-RM, 2-3 sets of 8-12 repetitions. Attention tasks, temporal space dissociation and dynamic balance exercises will be added to increase the difficulty and intensity in balance exercises. Flexibility and fine handle will be also performed. This intervention is individualized for each participant and is adjusted progressively during the 6 months. Weekly, two sessions of one hour are held and are supervised by physiotherapists or specialists in sports sciences trained specifically for the program. An interval of at least 48h between training sessions will be respected.

Official Title
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A Multicomponent Physical Exercise Program: a Tool to Maintain Autonomy, Reduce Frailty and Improve Functionality in Nursing Homes. Interventional Single Group Study

Conditions
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Activities of Daily Living, Frailty, Older Adults, Long Term Care

Intervention / Treatment
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* Other: Multicomponent physical exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥70years Scored ≥50 on the Barthel index Scored ≥20 on Mini Examen Cognoscitive test (MEC-35), validated and adapted Spanish version of Mini Mental State Examination Be able to stand up from the chair and walk 10 meters with or without one person/technical assistance. Exclusion Criteria: If the participants are clinically unstable under the clinical judgment of the medical professionals of the reference center, If the risk of adverse effects is greater than the benefit If the participants have severe cognitive or psychiatric disorders.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 115 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter single group interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Multicomponent physical exercise intervention | Other: Multicomponent physical exercise program<br>* The intervention consists of a combined multicomponent exercise program (EP) carried out for 6 months that includes strength, balance, flexibility and functional exercises aimed to improve functioning on daily life activities. The EP will be divided into two parts: The first 3 months the EP aims to restore the physical condition through the multicomponent exercise program. This program will comprise of upper and lower body strengthening exercises, using external weights for 2-3sets of 8-12repetitions at a progressive intensity of 30-50% of 1RM. In addition, static balance and flexibility exercise will be performed. From 3th to 6th months, the objective will be to improve autonomy through the functional EP. Strength exercises intensity will be increased to 60-70% of 1-RM, 2-3sets of 8-12repetitions. Attention tasks, temporal space dissociation and dynamic balance exercises will be added to increase the intensity in balance exercises. Flexibility and fine handle will be also performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index | Autonomy on daily living activities will be analyzed using the Barthel index. The Barthel index is a questionnaire with 10 items that evaluates the autonomy of the participant in the activities of daily life and it will be evaluated with the reference caregiver in nursing home. The Barthel index evaluates the following items: Feeding, Bathing, Dressing, Grooming, Bowels, Bladder, Toilette use, Transfer, Walking and Stairs. This items are scored as follows: 0 points if it is totally dependent, 5 points if needs some help and 10 points if the participant is totally autonomous | Changes from baseline to 3rd 6th and 12th month | 
| Short Physical Performance Battery | Short Physical Performance Battery (SPPB) evaluates balance, gait ability, and leg strength using a single tool. The score for each part is given in categorical modality (0-4). This set of tests serves to predict falls, weakness and mortality. The best score will be 12 points and total score less than 10 points indicates frailty and high risk of disability. 1 point of change in the total score has demonstrated to be of clinical relevance. | Changes from baseline to 3rd 6th and 12th month | 
| Handgrip strength | To asses upper limbs strength (kg) will be used bilateral handgrip strength test by squeezing a dynamometer with maximum isometric effort for 5 seconds. It is a strong predictor of disability, morbidity, and mortality as well as one of the components of Fried's frailty phenotype. Ranges are corrected by BMI | Changes from baseline to 3rd 6th and 12th month | 
| Timed Up and Go Test | Timed Up and Go (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The cut-off value for the TUG is 12 seconds The test score also correlates well with gait speed and the Barthel Index. | Changes from baseline to 3rd 6th and 12th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fried frailty index | Fried index uses 5 criteria to define frailty: weight loss, exhaustion, physical activity, walk time and grip strength. Fulfilling three of these criteria indicates clinical frailty. | Changes from baseline to 3rd 6th and 12th month | 
| Tilburg frailty indicator | Tilburg indicator evaluates frailty through a self-reported questionnaire that includes physical, psychological and social domains. The score range is from 0 points to 15 points. High scores indicates higher frailty | Changes from baseline to 3rd 6th and 12th month | 
| Rockwood frailty phenotype | 9 phenotype ranging from very fit to terminally ill are evaluated in Rockwood frailty scale. | Changes from baseline to 3rd 6th and 12th month | 
| Anthropometry-Weight | Weight (kg) | Changes from baseline to 3rd 6th and 12th month | 
| Anthropometry-Height | Height (m) | Changes from baseline to 3rd 6th and 12th month | 
| Body Mass Index | Body Mass Index (BMI), weight and height will be combined to report BMI in kg/m^2) | Changes from baseline to 3rd 6th and 12th month | 
| Anthropometry-Circumferences | Neck circumference, mid arm circumference and calf circumference (cm) | Changes from baseline to 3rd 6th and 12th month | 
| The Goldberg Anxiety and Depression Scale | The Goldberg Anxiety and Depression Scale will be used to assess affective state of anxiety and depression that includes nine depression and nine anxiety items from the last month. The cut-off points are ≥4 for the anxiety scale, and ≥2 for the depression scale. | Changes from baseline to 6th and 12th month | 
| The Spanish Subjective Happiness scale | The Spanish Subjective Happiness scale test will be used to analyze the perceived happiness. It ranges from 0 to 28 points in four questions. Higher punctuation means higher happiness level. | Changes from baseline to 6th and 12th month | 
| Quality of Life-Alzheimer Disease | Quality of Life-Alzheimer Disease (QoL-AD) test. Self-rated quality of life for people with cognitive impairments. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL. | Changes from baseline to 6th and 12th month | 
| Montreal Cognitive Assessment test (MOCA test) | The cognitive function will be assessed by MOCA test. Montreal Cognitive Assessment cover domains: attention and concentration, executive functions, memory and language skills, conceptual thinking, calculation and orientation. The MOCA is a validated test in Spanish. It ranges from 0 ( worse score ) to 30 (best score). A score less than 26 indicates suggest mild cognitive decline | Changes from baseline to 6th and 12th month | 
| Pain level | Using a score from 0 points (lowest) to 10 points (highest) the participant will be asked to say how much it hurts in different parts of the body such as shoulders, elbows, wrists, neck, back, hips, knees and ankles | Changes from baseline to 6th and 12th month | 
| Clinical outcomes-Number of falls | Number of falls will be assessed with a clinical questionnaire | The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months | 
| Clinical outcomes-visits to the emergency service | Visits to the emergency service will be assessed with a clinical questionnaire | The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months | 
| Clinical outcomes-hospital admissions | Hospital admissions will be assessed with a clinical questionnaire | The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months | 
| Clinical outcomes-functional impairment | Functional impairment after hospitalization will be assessed with a clinical questionnaire | The data will be collected one year and 6 months before starting the project, at intervention baseline, at 6 months and at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physical Activity, Aging