Clinical trial NCT02847871: Elderly Patient at Risk of Loss of Mobility, Exercise - Primary Care, Prevention, Care Pathways
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Patient (>70 Years)
Loss of Mobility
Keywords: mobility
exercise
nutrition
primary care
prevention
care pathway
elderly patient
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 39
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Change in Short Physical Performance Battery (SPPB) score
timeFrame: from baseline at 6 months
Secondary outcomes:
measure: Evolution of the Short Physical Performance Battery (SPPB) score
timeFrame: Baseline, 3 months (for interventional arm), 6 months and 12 months
measure: Assessment of functional disability by questionnaires
timeFrame: Baseline, 6 months and 12 months
measure: Assessment of Quality of Life by questionnaire
timeFrame: baseline, 6 months and 12 months
measure: Number of falls
timeFrame: Baseline, 6 months and 12 months
measure: Number of hospitalization
timeFrame: Baseline, 6 months and 12 months
measure: Assessment of the Physical Activity by questionnaire
timeFrame: baseline, 6 months and 12 months
measure: Assessment of sedentary time by questionnaire
timeFrame: baseline, 6 months and 12 months
measure: Assessment of weight loss
timeFrame: baseline, 6 months and 12 months
measure: Body Mass Index (BMI)
timeFrame: baseline, 6 months and 12 months
measure: Assessment of nutritional status using MNA scale
timeFrame: baseline, 3 months (for interventional arm depending on the SPPB score), 6 months and 12 months
measure: Rate of study participation
timeFrame: Baseline
measure: Monitoring of detailed physical activity performed by patients with diaries outlining the exercise sessions .
timeFrame: at the end of the multimodal intervention (3 months)
measure: Monitoring of detailed physical activity performed by patients with MAPA assessment.
timeFrame: at the end of the multimodal intervention (3 months)
measure: Rate of compliant General practitioners (GP) associated to the study
timeFrame: at 12 months
measure: Assessment of psychological factors using GDS-4 scale associated with a loss of mobility
timeFrame: baseline, 6 and 12 months
measure: Assessment of social factors associated with a loss of mobility
timeFrame: baseline
measure: Assessment of comorbidities using the index of Charlson
timeFrame: baseline
measure: Description of concomitant medications
timeFrame: baseline
measure: Type of diagnoses for unknown diseases following the dedicated geriatric consultation.
timeFrame: baseline
measure: Percentage of diagnoses for unknown diseases following the dedicated geriatric consultation.
timeFrame: baseline
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.
Study officials:
affiliation: Hospices Civils de Lyon
name: Marc BONNEFOY, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.