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

NCT ID: NCT02847871

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-16
• Study Completion Date: 2021-03-01

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.

Conditions

Elderly Patient (>70 Years); Loss of Mobility

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

PRISME-3P program

Intervention Type: BEHAVIORAL

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.

Non interventional

Patients received treatment as part of their standard care: at the discretion of the general practitioner patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc BONNEFOY, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.

Pierre-Bénite, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 30782118 (View on PubMed)

Other Identifiers

69HCL16_0132

Identifier Type: -

Identifier Source: org_study_id