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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Change in Short Physical Performance Battery (SPPB) score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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)
Outcomes
Primary Outcomes
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
- Assessment of the Physical Activity by questionnaire(baseline, 6 months and 12 months)
- Assessment of functional disability by questionnaires(Baseline, 6 months and 12 months)
- Evolution of the Short Physical Performance Battery (SPPB) score(Baseline, 3 months (for interventional arm), 6 months and 12 months)
- Assessment of Quality of Life by questionnaire(baseline, 6 months and 12 months)
- Number of falls(Baseline, 6 months and 12 months)
- Number of hospitalization(Baseline, 6 months and 12 months)
- Body Mass Index (BMI)(baseline, 6 months and 12 months)
- Assessment of sedentary time by questionnaire(baseline, 6 months and 12 months)
- Assessment of weight loss(baseline, 6 months and 12 months)
- Assessment of nutritional status using MNA scale(baseline, 3 months (for interventional arm depending on the SPPB score), 6 months and 12 months)
- Rate of study participation(Baseline)
- Assessment of psychological factors using GDS-4 scale associated with a loss of mobility(baseline, 6 and 12 months)
- Assessment of comorbidities using the index of Charlson(baseline)
- Monitoring of detailed physical activity performed by patients with diaries outlining the exercise sessions .(at the end of the multimodal intervention (3 months))
- Assessment of social factors associated with a loss of mobility(baseline)
- Monitoring of detailed physical activity performed by patients with MAPA assessment.(at the end of the multimodal intervention (3 months))
- Rate of compliant General practitioners (GP) associated to the study(at 12 months)
- Description of concomitant medications(baseline)
- Type of diagnoses for unknown diseases following the dedicated geriatric consultation.(baseline)
- Percentage of diagnoses for unknown diseases following the dedicated geriatric consultation.(baseline)