PREPA PREvention of Loss of Autonomy (PREPA)

  • STATUS
    Recruiting
  • End date
    Jul 22, 2023
  • participants needed
    400
  • sponsor
    Hospices Civils de Lyon
Updated on 14 February 2022
nutritional counseling

Summary

According to several reports, the percentage of persons aged of more than 80 years is going to be doubled for the 25 years, to reach 10 % of the population. This implies an adaptation of practices of taken care for elderly people. Furthermore, the expectancy of life without any disability at 65 years old is 10.4 years and remains much lower than the general expectancy of life, which is of 24.4 years for women and 19.1 years for men.

Among predictive factors of loss of autonomy, the loss of mobility and muscular weakness are major components (OR=3.28 up to 3 years). These two factors are the origins for disabilities being responsible of falls, fractures, which lead to quality of life diminution, and increase of mortality.

The only components easily employed in a preventive manner and which have proved their efficacy are physical exercise and nutrition. But programs nowadays are still not implemented into primary taken care.

A multimodal program including these two components for patients at risk of loss of mobility is an imperative of public health.

Description

Two groups will be identified :

A first group with a SPPB (Short physical performance battery) score between 8 and 10 and walking more than 90 minutes per week. They will be asked to carry out 2 to 3 times a week a series of exercises concerning the main muscle groups, using bodyweight, and without specific equipment. An activity booklet will be given as support. In a complementary way, individual objectives will be established to develop endurance by fighting against hyper-sedentariness based on simple advice to the patient and his entourage. The volume of physical activity will be developed from activities of daily living. A telephone coaching will be carried out every 4 weeks by a Adapted Physical Activity Monitor and a precise evaluation of the physical performances will be carried out at 3 months.

A second group for patients with Short physical performance battery 8 or if >8 but excessive sedentary walking less than 90 minutes per week, including running, or having sarcopenia criteria.

They will be offered bi-weekly care by a Adapted Physical Activity Monitor. Training will be conducted either in small group programs or at home (if unable to attend), at the frequency of 2 sessions per week for 10 weeks. The personalized program of muscular reinforcement will be of progressive intensity with and without additional load and with very simple and easily usable devices including at home (elastic bands, weights. . . ).

During the dedicated geriatric consultation, the nutritional status will also be evaluated by a food survey and biological samples in order to measure the usual serum nutritional markers. The objective of the assessment is to ensure an adequate intake of macro nutrients, including proteins, and energy; as well as micronutrient fruits and vegetables rich in antioxidants and omega 3 fatty acids which also have a significant impact in terms of prevention and muscle function.

Loss of autonomy : (ADL) Activities of Daily Living score will be calculated. This validated scale requires 3 evaluations spread over time. A score > 6 indicates an addiction.

(Instrumental Activities of Daily Living) Lawton's IADL scale is essentially focused on the person's usual behaviour and essentially assesses a patient's level of dependence through the assessment of activities of daily living.

Useful for assessing the patient's state of functional autonomy and deciding on appropriate aids (meals at home, household helper, life support, legal protection).

Details
Condition Mobility Limitation, Physical Activity
Treatment Physical exercises et nutritional counseling in elderly people at risks of loss of autonomy
Clinical Study IdentifierNCT03667664
SponsorHospices Civils de Lyon
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Elder people aged of 70 years
With at least two of the following signs
Difficulty to stand up from a chair without using arms
Difficulty to climb a floor (10 steps)
Difficulty to move, slow walk
Difficulty to walk more than 400 meters without any stop
Walk activity less than 1h per week
Tiredness whilst doing moderate physical activities : home cleaning, shopping
A least two falls during last year
Unintentional loss of weight: loss of 5 % in one month, 10 % in 6 months, or BMI< 21kg/m2
Short Physical Performance Battery (SPPB) score < 10 or Hand Grip < 16 kg for women and< 26 kg for men

Exclusion Criteria

Patient unable to express his participation refusal and under curators or unforced by the court of justice
Locomotor disability
expectancy of life being under 12 months
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