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Completed

NCT Number: NCT02847871

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

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.

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Key information

Conditions

Elderly Patient (>70 Years) Behavior Loss of Mobility Motor Activity

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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)

Treatment and study plan

PRISME-3P program

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evolution of the Short Physical Performance Battery (SPPB) score

    Time frame: 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.

  2. Assessment of functional disability by questionnaires

    Time frame: 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

  3. Assessment of Quality of Life by questionnaire

    Time frame: 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

  4. Number of falls

    Time frame: Baseline, 6 months and 12 months

    Data will be collected by the geriatrician from the patient's medical records

  5. Number of hospitalization

    Time frame: Baseline, 6 months and 12 months

    Data will be collected by the geriatrician from the patient's medical records

  6. Assessment of the Physical Activity by questionnaire

    Time frame: 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.

  7. Assessment of sedentary time by questionnaire

    Time frame: 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)

  8. Assessment of weight loss

    Time frame: baseline, 6 months and 12 months

    weight in kilograms

  9. Body Mass Index (BMI)

    Time frame: baseline, 6 months and 12 months

    calculating the BMI in kg/m^2

  10. 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

    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.

  11. Rate of study participation

    Time frame: Baseline

  12. 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)

    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.

  13. Monitoring of detailed physical activity performed by patients with MAPA assessment.

    Time frame: 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.

  14. Rate of compliant General practitioners (GP) associated to the study

    Time frame: at 12 months

  15. Assessment of psychological factors using GDS-4 scale associated with a loss of mobility

    Time frame: 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.

  16. Assessment of social factors associated with a loss of mobility

    Time frame: 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).

  17. Assessment of comorbidities using the index of Charlson

    Time frame: baseline

    Using the index of Charlson which included a closed list of 19 diseases, grouped into 4 subgroups different weighting.

  18. Description of concomitant medications

    Time frame: baseline

    List of active drugs and psychotropic

  19. Type of diagnoses for unknown diseases following the dedicated geriatric consultation.

    Time frame: baseline

    Description of pathologies possibly associated with a symptomatic loss of mobility.

  20. Percentage of diagnoses for unknown diseases following the dedicated geriatric consultation.

    Time frame: baseline

    Description of pathologies possibly associated with a symptomatic loss of mobility.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: PRISME-3P

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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