PREPA PREvention of Loss of Autonomy

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03667664

Collaborator

(none)

400

Enrollment

Location

Arm

59.7

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mobility Limitation Physical Activity	Behavioral: Physical exercises et nutritional counseling in elderly people at risks of loss of autonomy	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Actual Study Start Date :

Jul 10, 2018

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Prevention of loss of autonomy Lifestyle counseling for elderly people about physical exercises and nutrition in a preventive way	Behavioral: Physical exercises et nutritional counseling in elderly people at risks of loss of autonomy Pre-program : eligibility criteria, nutritional status (MNA score, BMI, recent loss of weight), previous history, comorbidities, clinical examination, number of loss in the previous year, Rapid Assessment of Physical Activity score, activities of daily living and Instrumental activities of daily living, Medical Outcome Study Short Form 36 score, physical tests (Hand grip, Short Physical Performance Battery, Knee extension, Neurocom platform physical tests, Dual X-Ray Absorptiometry and Bio-impedance for Body Mass measurement, Muscular echography. Implementation of a one year multimodal program based on physical exercises and nutrition counseling as a way of preventing dependence and loss of autonomy in elderly people.

Arm

Intervention/Treatment

Other: Prevention of loss of autonomy

Lifestyle counseling for elderly people about physical exercises and nutrition in a preventive way

Behavioral: Physical exercises et nutritional counseling in elderly people at risks of loss of autonomy

Pre-program : eligibility criteria, nutritional status (MNA score, BMI, recent loss of weight), previous history, comorbidities, clinical examination, number of loss in the previous year, Rapid Assessment of Physical Activity score, activities of daily living and Instrumental activities of daily living, Medical Outcome Study Short Form 36 score, physical tests (Hand grip, Short Physical Performance Battery, Knee extension, Neurocom platform physical tests, Dual X-Ray Absorptiometry and Bio-impedance for Body Mass measurement, Muscular echography. Implementation of a one year multimodal program based on physical exercises and nutrition counseling as a way of preventing dependence and loss of autonomy in elderly people.

Outcome Measures

Primary Outcome Measures

Physical functional status [At three months]
Physical functional status will be evaluated by the Short Physical Performance Battery (SPPB) tests. This is composite measurement. SPPB tests is described as follows: 3 tests scored from 1 to 4, then summed up in a global score : Gait speed test (over 6 m), in meter/sec, Stand-up chair test (time in seconds to perform 5 up an go sitting from a chair), Balance test (time in seconds to be able to maintain 3 different positions of standing up on balance position). This global score enables to have a global overview of functional status of an elderly person. Global score is scored at a maximum of 12. Score between 0 to 6 is considered being at risk of loss of mobility. An increase of 1 point after three months of practical exercises will be considered significant.

Secondary Outcome Measures

Physical performance : Hand grip test [At three months]
Hand grip test measures the strength of the hand gripping the device as strong as possible, and strength is measured in kg.
Knee extension test [At three months]
The strength of extension muscle starting from the knee is measured from appropriate device, in kg.
Body repartition during crossing an obstacle [At inclusion]
The percentage of body repartition is evaluated between the right side and the left side of the body, whilst crossing of an obstacle.
Time needed for crossing an obstacle [At inclusion]
Time needed to cross the obstacle is measured
Sitting/standing up alternance [At inclusion]
Time in seconds is recorded to measure necessary time from the sitting position up to standing position.
Body mass measurement by impedancemetry [At three months]
Composition of body mass is evaluated through bio-impedancemetry. It is used to determine the amount of water, fat and muscle. Measurements are made by simply placing electrodes on the body, and recording the resistance of biological tissues by sending a sinusoidal current of low intensity (about a milliampere) and high frequency (10-100 kHz) through these electrodes.
Body mass measurement by Dual Energy X-Ray Absorptiometry [At three months]
Composition of body mass is evaluated through Dual Energy X-Ray Absorptiometry. Dual-energy X-ray absorptiometry is a means of measuring total body composition with a high degree of accuracy. Two X-ray beams, with different energy levels, are aimed at the patient's bones. This technic uses a very small dose of ionizing radiation to produce pictures of the inside of the body.
Nutrition [At inclusion, three, six and twelve months]
Evolution of Body Weight is measured in kg
Functionality [At inclusion, three and twelve months]
Katz scores ( ADL : Activities of daily living) This validated scale requires 3 evaluations spread over time. A score > 6 indicates an addiction. Useful for assessing the patient's state of functional autonomy and deciding on appropriate aids (meals at home, household helper, life support, legal protection).
Functionality [At inclusion, three and twelve months]
Lawton scores (IADL - Instrumental Activities of Daily Living)
Echography of Muscles [At inclusion, three, six and twelve months]
Echography constitutes a method of choice in the evaluation of muscular structures. Ultrasound is used there as a screening tool for clinicians to assess/prevent physical decline during hospitalization. A good anatomical knowledge of the weakness sites, as well as knowledge of traumatic signs and symptoms is essential in order to deliver a precise report. Muscle architecture of lower and upper limbs will be collected with an echography. Pennation angle (PA), muscle thickness (MT), and fiber length (all measured in mm) and Skeletal Muscle Index Report (muscle mass of the 4 limbs squared to the waist) will be measured/calculated there.
Falls [At inclusion, 4 weeks, three, six, twelve months]
Frequency of falls will be recorded at these different times, when these one will be considered as being traumatic falls, and/or conducting to hospitalizations or admissions in institutions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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