Clinical trial NCT03667664: PREPA PREvention of Loss of Autonomy
Official title: Prevention Study, on Loss of Autonomy and Physical Dependence, Based on Physical Exercises and Nutrition Counseling Applied to 70 Years Old and More People.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mobility Limitation
Physical Activity
Keywords: Autonomy
Elderly
Physical exercise
Nutrition
Prevention
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 400
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Physical functional status
timeFrame: At three months
Secondary outcomes:
measure: Physical performance : Hand grip test
timeFrame: At three months
measure: Knee extension test
timeFrame: At three months
measure: Body repartition during crossing an obstacle
timeFrame: At inclusion
measure: Time needed for crossing an obstacle
timeFrame: At inclusion
measure: Sitting/standing up alternance
timeFrame: At inclusion
measure: Body mass measurement by impedancemetry
timeFrame: At three months
measure: Body mass measurement by Dual Energy X-Ray Absorptiometry
timeFrame: At three months
measure: Nutrition
timeFrame: At inclusion, three, six and twelve months
measure: Functionality
timeFrame: At inclusion, three and twelve months
measure: Functionality
timeFrame: At inclusion, three and twelve months
measure: Echography of Muscles
timeFrame: At inclusion, three, six and twelve months
measure: Falls
timeFrame: At inclusion, 4 weeks, three, six, twelve months
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de Médecine Gériatrique Groupement Hospitalier Sud
Study officials:
References: