Elderly Patient (>70 Years)PRISME-3PNCT02847871
Elderly Patient at Risk of Loss of Mobility, Exercise - Primary Care, Prevention, Care Pathways
A study testing PRISME-3P program in people with Elderly Patient (>70 Years) and Loss of Mobility, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly Patient (>70 Years), Loss of Mobility
- What is being tested?
- PRISME-3P program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2018to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.
Pierre-Bénite, 69310
About this study
Official title: 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.
Read more
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
- Being tested
- PRISME-3P program
- Keywords
- mobility, exercise, nutrition, primary care, prevention, care pathway, elderly patient
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISME-3P programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Intervention | Other | 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. Receives: Behavioral: PRISME-3P program |
| Non interventional | No intervention | Patients received treatment as part of their standard care: at the discretion of the general practitioner patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline at 6 months
Secondary outcomes (20)
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.
Measured: 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
Measured: 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
Measured: baseline, 6 months and 12 months
Number of falls
Data will be collected by the geriatrician from the patient's medical records
Measured: Baseline, 6 months and 12 months
Number of hospitalization
Data will be collected by the geriatrician from the patient's medical records
Measured: 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.
Measured: 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)
Measured: baseline, 6 months and 12 months
Assessment of weight loss
weight in kilograms
Measured: baseline, 6 months and 12 months
Body Mass Index (BMI)
calculating the BMI in kg/m^2
Measured: 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.
Measured: baseline, 3 months (for interventional arm depending on the SPPB score), 6 months and 12 months
Rate of study participation
Measured: 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.
Measured: 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.
Measured: at the end of the multimodal intervention (3 months)
Rate of compliant General practitioners (GP) associated to the study
Measured: 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.
Measured: 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).
Measured: 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.
Measured: baseline
Description of concomitant medications
List of active drugs and psychotropic
Measured: baseline
Type of diagnoses for unknown diseases following the dedicated geriatric consultation.
Description of pathologies possibly associated with a symptomatic loss of mobility.
Measured: baseline
Percentage of diagnoses for unknown diseases following the dedicated geriatric consultation.
Description of pathologies possibly associated with a symptomatic loss of mobility.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start16 May 2018
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly Patient (>70 Years)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc BONNEFOY, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847871
- Sponsor's protocol ID
- 69HCL16_0132
- Acronym
- PRISME-3P
- Status last verified
- Dec 2025
- First submitted
- 21 Jul 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30782118
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02847871
- Acronym / sponsor ID
- PRISME-3P / 69HCL16_0132
- Conditions
- Elderly Patient (>70 Years), Loss of Mobility
- Keywords
- mobility, exercise, nutrition, primary care, prevention, care pathway, elderly patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Intervention | Other | Behavioral: PRISME-3P programThe 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. |
| Non interventional | No intervention | –Patients received treatment as part of their standard care: at the discretion of the general practitioner patients |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Aged > 70 years
- With at least 2 of the following signs:
- Short Physical Performance Battery score < 10
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRISME-3P programPRISM-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. | Behavioural | Multimodal Intervention |
Primary outcome
Change in Short Physical Performance Battery (SPPB) score
Time frame: 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.
20 secondary outcomes
Evolution of the Short Physical Performance Battery (SPPB) score
Time frame: Baseline, 3 months (for interventional arm), 6 months and 12 months
Assessment of functional disability by questionnaires
Time frame: Baseline, 6 months and 12 months
Assessment of Quality of Life by questionnaire
Time frame: baseline, 6 months and 12 months
Number of falls
Time frame: Baseline, 6 months and 12 months
Number of hospitalization
Time frame: Baseline, 6 months and 12 months
Assessment of the Physical Activity by questionnaire
Time frame: baseline, 6 months and 12 months
Assessment of sedentary time by questionnaire
Time frame: baseline, 6 months and 12 months
Assessment of weight loss
Time frame: baseline, 6 months and 12 months
Body Mass Index (BMI)
Time frame: baseline, 6 months and 12 months
Assessment of nutritional status using MNA scale
Time frame: baseline, 3 months (for interventional arm depending on the SPPB score), 6 months and 12 months
Rate of study participation
Time frame: Baseline
Monitoring of detailed physical activity performed by patients with diaries outlining the exercise sessions .
Time frame: at the end of the multimodal intervention (3 months)
Monitoring of detailed physical activity performed by patients with MAPA assessment.
Time frame: at the end of the multimodal intervention (3 months)
Rate of compliant General practitioners (GP) associated to the study
Time frame: at 12 months
Assessment of psychological factors using GDS-4 scale associated with a loss of mobility
Time frame: baseline, 6 and 12 months
Assessment of social factors associated with a loss of mobility
Time frame: baseline
Assessment of comorbidities using the index of Charlson
Time frame: baseline
Description of concomitant medications
Time frame: baseline
Type of diagnoses for unknown diseases following the dedicated geriatric consultation.
Time frame: baseline
Percentage of diagnoses for unknown diseases following the dedicated geriatric consultation.
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 30782118Perrotin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc BONNEFOY, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISME-3P program in people with Elderly Patient (>70 Years) and Loss of Mobility, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Physical Performance Battery (SPPB) score (time frame: from baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.