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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02847871
Acronym
PRISME-3P
Enrollment
39
Registered
2016-07-28
Start date
2018-05-16
Completion date
2021-03-01
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Patient (>70 Years), Loss of Mobility

Keywords

mobility, exercise, nutrition, primary care, prevention, care pathway, elderly patient

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.

Interventions

BEHAVIORALPRISME-3P program

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged \> 70 years * With at least 2 of the following signs: 1. Difficulty in carrying a shopping bag (load about 4.5 Kg) 2. Difficulty in getting up from a chair without using arms 3. Difficulty in climbing 10 stairs 4. Difficulty in moving, walking slow 5. Difficulty in walking more than 400 meters without stop 6. Running time \<1 hour / week 7. Fatigue at modest physical effort: shopping, housework ... 8. At least two falls in the last year 9. 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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Short Physical Performance Battery (SPPB) scorefrom baseline at 6 monthsConsists 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

MeasureTime frameDescription
Assessment of functional disability by questionnairesBaseline, 6 months and 12 monthsFunctional 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
Assessment of Quality of Life by questionnairebaseline, 6 months and 12 monthsThe 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 fallsBaseline, 6 months and 12 monthsData will be collected by the geriatrician from the patient's medical records
Number of hospitalizationBaseline, 6 months and 12 monthsData will be collected by the geriatrician from the patient's medical records
Type of diagnoses for unknown diseases following the dedicated geriatric consultation.baselineDescription of pathologies possibly associated with a symptomatic loss of mobility.
Assessment of the Physical Activity by questionnairebaseline, 6 months and 12 monthsUsing 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 sedentary time by questionnairebaseline, 6 months and 12 monthsUsing 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 weight lossbaseline, 6 months and 12 monthsweight in kilograms
Body Mass Index (BMI)baseline, 6 months and 12 monthscalculating the BMI in kg/m\^2
Evolution of the Short Physical Performance Battery (SPPB) scoreBaseline, 3 months (for interventional arm), 6 months and 12 monthsConsists 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.
Rate of study participationBaseline
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.
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 studyat 12 months
Assessment of psychological factors using GDS-4 scale associated with a loss of mobilitybaseline, 6 and 12 monthsUsing 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 social factors associated with a loss of mobilitybaselineUsing 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).
Assessment of comorbidities using the index of CharlsonbaselineUsing the index of Charlson which included a closed list of 19 diseases, grouped into 4 subgroups different weighting.
Description of concomitant medicationsbaselineList of active drugs and psychotropic
Percentage of diagnoses for unknown diseases following the dedicated geriatric consultation.baselineDescription of pathologies possibly associated with a symptomatic loss of mobility.
Assessment of nutritional status using MNA scalebaseline, 3 months (for interventional arm depending on the SPPB score), 6 months and 12 monthsUsing 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026