Elderly Patient at Risk of Loss of Mobility, Exercise - Primary Care, Prevention, Care Pathways

Study Overview
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Brief Summary
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Loss of mobility is predictive of a loss of autonomy and is often the first sign of functional decline. Loss of mobility is also associated with poor perceived quality of life, depressive symptoms, high risk of adverse events such as falls and fractures, to an increased risk to input in institution and mortality's increase. Consequences and frequency of loss of mobility make essential its identification, evaluation and the practice of preventive measures in primary care. The implementation of effective interventions in primary care to prevent or delay the loss of mobility is a public health priority. PRISME-3P program aims to develop and evaluate a dedicated care pathway, in primary care, based on a personalized multimodal intervention: screening, support combining physician, teaching exercises by a specialized Monitor in Adapted Physical Activities (MAPA) and nutritional counseling.

Official Title
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Prevention of Loss of Mobility From a Care Pathway Focused on Exercise and Nutrition in Elderly Patients Over 70 Years, in Primary Care. Cluster Randomized Controlled Trial

Conditions
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Elderly Patient (>70 Years), Loss of Mobility

Intervention / Treatment
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* Behavioral: PRISME-3P program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged > 70 years With at least 2 of the following signs: Difficulty in carrying a shopping bag (load about 4.5 Kg) Difficulty in getting up from a chair without using arms Difficulty in climbing 10 stairs Difficulty in moving, walking slow Difficulty in walking more than 400 meters without stop Running time <1 hour / week Fatigue at modest physical effort: shopping, housework ... At least two falls in the last year Weight loss ≥5% in 1 month or weight loss ≥10% in 6 months Short Physical Performance Battery score < 10 Exclusion Criteria: Locomotor disability not allowing implementation of the protocol according to the investigator Life expectancy less than 6 months Severe chronic progressive pathologies incompatible with the completion of the physical activity program Patient institutionalized in nursing homes Advanced Cognitive impairment (MMSE <20)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multimodal Intervention<br>The multimodal intervention on mobility will consist of the implementation of a care pathway dedicated in primary care. It will include awareness and training of general practitioners for easy identification, a care associating a dedicated geriatric consultation to rule out underlying pathology, teaching exercises by MAPA (+/- taken care in the presence of MAPA) and nutritional counseling by a dietician. Close collaboration between general practitioners, geriatrician, MAPA and dietician will be established. | Behavioral: PRISME-3P program<br>* PRISM-3P program will consist on a visit in the geriatric centre: Consultation with the geriatrician to rule a condition associated with loss of mobility and not known until now. Perform a nutritional assessment by a dietician followed by appropriate care management. Educational activity based on exercises and physical activity and balance: MAPA teaches exercises to develop strength and balance; gives tips to increase time spent on non-sedentary activities and enhance endurance followed by a monthly phone coaching. At 3 months, in case of no improvement of the SPPB score of 1 point, a training of 10 weeks with two sessions per week will be perform by the MAPA individually or in small patients groups; Implementation of a information exchange processing (mail, phone and book binding) between the various stakeholders.<br>|
| No Intervention: Non interventional<br>Patients received treatment as part of their standard care: at the discretion of the general practitioner patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Physical Performance Battery (SPPB) score | Consists in estimating three components: 1. walking, 2. muscular strength and endurance, and 3. balance through short physical exercises (walk on a defined distance, get up from a chair, keep a position up). A score from 1 to 3 for each of the components marks a very low feature of lower limbs. This feature is considered low of 4 in 6, moderated by 7 in 9 and high of 10 in 12. | from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the Short Physical Performance Battery (SPPB) score | Consists in estimating three components: 1.walking, 2.muscular strength and endurance, and 3. balance through short physical exercises (walk on a defined distance, get up from a chair, keep a position up). A score from 1 to 3 for each of the components marks a very low feature of lower limbs. This feature is considered low of 4 in 6, moderated by 7 in 9 and high of 10 in 12. | Baseline, 3 months (for interventional arm), 6 months and 12 months | 
| Assessment of functional disability by questionnaires | Functional disability refers to limitations in performing in dependent living tasks, which are often further divided into activities of daily living (ADLs), which include basic activities of hygiene and personal care, and instrumental activities of daily living (IADLs), which include basic activities necessary to reside in the community, such as shopping, managing finances, housekeeping, and meal preparation | Baseline, 6 months and 12 months | 
| Assessment of Quality of Life by questionnaire | The Quality of Life is assessed with the 12-Item Short Form Health Survey (SF-12). The SF-12 is a multipurpose short form survey with 12 questions which were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life | baseline, 6 months and 12 months | 
| Number of falls | Data will be collected by the geriatrician from the patient's medical records | Baseline, 6 months and 12 months | 
| Number of hospitalization | Data will be collected by the geriatrician from the patient's medical records | Baseline, 6 months and 12 months | 
| Assessment of the Physical Activity by questionnaire | Using the Physical Activity Scale for the Elderly (PASE) auto-questionnaire which is designed to assess the duration, frequency, exertion level, and amount of physical activity undertaken over a seven day period. | baseline, 6 months and 12 months | 
| Assessment of sedentary time by questionnaire | Using self-report sedentary behavior questionnaire based on the Gardiner questionnaire to assess time spent in behaviors common among older adults: watching television, computer use, reading, socializing, transport and hobbies, and a summary measure (total sedentary time) | baseline, 6 months and 12 months | 
| Assessment of weight loss | weight in kilograms | baseline, 6 months and 12 months | 
| Body Mass Index (BMI) | calculating the BMI in kg/m^2 | baseline, 6 months and 12 months | 
| Assessment of nutritional status using MNA scale | Using the Mini Nutritional Assessment (MNA) scale which consists of 18 point-weighted questions in four categories, i.e., anthropometry, global and dietary issues, and self-assessment. | baseline, 3 months (for interventional arm depending on the SPPB score), 6 months and 12 months | 
| Rate of study participation |  | Baseline | 
| Monitoring of detailed physical activity performed by patients with diaries outlining the exercise sessions . | Patient adherence to the multimodal intervention. Monitoring of detailed physical activity performed by patients. Patients were also asked to complete diaries outlining the exercise sessions. | at the end of the multimodal intervention (3 months) | 
| Monitoring of detailed physical activity performed by patients with MAPA assessment. | Patient adherence to the multimodal intervention. Monitoring of detailed physical activity performed by patients. Patients MAPA assessment. | at the end of the multimodal intervention (3 months) | 
| Rate of compliant General practitioners (GP) associated to the study |  | at 12 months | 
| Assessment of psychological factors using GDS-4 scale associated with a loss of mobility | Using a short Geriatric Depression Scale (GDS-4). The GDS may be used with healthy, medically ill and mild to moderately cognitively impaired older adults. | baseline, 6 and 12 months | 
| Assessment of social factors associated with a loss of mobility | Using the Evaluation of Precarity and Inequalities in Health Examination Centers (EPICES) score which is related to several socioeconomic indicators (occupation, education, and employment status), to health-related behaviors (smoking and health care use), and morbidity (self-perceived health, dental health, obesity, and diabetes). | baseline | 
| Assessment of comorbidities using the index of Charlson | Using the index of Charlson which included a closed list of 19 diseases, grouped into 4 subgroups different weighting. | baseline | 
| Description of concomitant medications | List of active drugs and psychotropic | baseline | 
| Type of diagnoses for unknown diseases following the dedicated geriatric consultation. | Description of pathologies possibly associated with a symptomatic loss of mobility. | baseline | 
| Percentage of diagnoses for unknown diseases following the dedicated geriatric consultation. | Description of pathologies possibly associated with a symptomatic loss of mobility. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobility, exercise, nutrition, primary care, prevention, care pathway, elderly patient