Elderly Patient at Risk of Loss of Mobility, Exercise - Primary Care, Prevention, Care Pathways
- Conditions
- Elderly Patient (>70 Years)Loss of Mobility
- Interventions
- Behavioral: PRISME-3P program
- Registration Number
- NCT02847871
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
-
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multimodal Intervention PRISME-3P program 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.
- Primary Outcome Measures
Name Time Method Change in Short Physical Performance Battery (SPPB) score from baseline at 6 months 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.
- Secondary Outcome Measures
Name Time Method Assessment of weight loss baseline, 6 months and 12 months weight in kilograms
Assessment of the Physical Activity by questionnaire baseline, 6 months and 12 months 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.
Assessment of functional disability by questionnaires Baseline, 6 months and 12 months 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
Evolution of the Short Physical Performance Battery (SPPB) score Baseline, 3 months (for interventional arm), 6 months and 12 months 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.
Assessment of Quality of Life by questionnaire baseline, 6 months and 12 months 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
Number of falls Baseline, 6 months and 12 months Data will be collected by the geriatrician from the patient's medical records
Number of hospitalization Baseline, 6 months and 12 months Data will be collected by the geriatrician from the patient's medical records
Body Mass Index (BMI) baseline, 6 months and 12 months calculating the BMI in kg/m\^2
Assessment of sedentary time by questionnaire baseline, 6 months and 12 months 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)
Assessment of nutritional status using MNA scale baseline, 3 months (for interventional arm depending on the SPPB score), 6 months and 12 months 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.
Rate of study participation Baseline Assessment of psychological factors using GDS-4 scale associated with a loss of mobility baseline, 6 and 12 months 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.
Assessment of comorbidities using the index of Charlson baseline Using the index of Charlson which included a closed list of 19 diseases, grouped into 4 subgroups different weighting.
Monitoring of detailed physical activity performed by patients with diaries outlining the exercise sessions . at the end of the multimodal intervention (3 months) 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.
Assessment of social factors associated with a loss of mobility baseline 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).
Monitoring of detailed physical activity performed by patients with MAPA assessment. at the end of the multimodal intervention (3 months) Patient adherence to the multimodal intervention. Monitoring of detailed physical activity performed by patients. Patients MAPA assessment.
Rate of compliant General practitioners (GP) associated to the study at 12 months Description of concomitant medications baseline List of active drugs and psychotropic
Type of diagnoses for unknown diseases following the dedicated geriatric consultation. baseline Description of pathologies possibly associated with a symptomatic loss of mobility.
Percentage of diagnoses for unknown diseases following the dedicated geriatric consultation. baseline Description of pathologies possibly associated with a symptomatic loss of mobility.
Trial Locations
- Locations (1)
Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.
🇫🇷Pierre-Bénite, France