Elderly Patient at Risk of Loss of Mobility, Exercise - Primary Care, Prevention, Care Pathways (PRISME-3P)

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

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.

Study Overview

• Status: Completed
• Conditions: Elderly Patient (>70 Years); Loss of Mobility
• Intervention / Treatment: Behavioral: PRISME-3P program

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Multimodal Intervention; 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; 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.
No Intervention: Non interventional; Patients received treatment as part of their standard care: at the discretion of the general practitioner patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Marc BONNEFOY, Pr, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Perrotin S, Gilbert T, Dupuis M, Villeneuve L, Bin-Dorel S, Klich A, Letrilliart L, Bonnefoy M. A multimodal and multidisciplinary program to prevent loss of mobility in patients aged over 70 years: study protocol of a multicenter cluster randomized study in primary care (the PRISME-3P study). BMC Geriatr. 2019 Feb 19;19(1):48. doi: 10.1186/s12877-019-1059-5.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimated): July 28, 2016

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: exercise; nutrition; primary care; prevention; mobility; care pathway; elderly patient
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 69HCL16_0132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No