PREPA PREvention of Loss of Autonomy

Physical Activity Clinical Trial

— PREPA  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03667664
• Other study ID #: 69HCL16_0324
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: July 2023

Study information

• Verified date: January 2018
• Source: Hospices Civils de Lyon
• Contact: Marc BONNEFOY, PU-PH
• Phone: 04 78 86 15 81
• Email: marc.bonnefoy[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
France	Service de Médecine Gériatrique Groupement Hospitalier Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical functional status	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.	At three months
Secondary	Physical performance : Hand grip test	Hand grip test measures the strength of the hand gripping the device as strong as possible, and strength is measured in kg.	At three months
Secondary	Knee extension test	The strength of extension muscle starting from the knee is measured from appropriate device, in kg.	At three months
Secondary	Body repartition during crossing an obstacle	The percentage of body repartition is evaluated between the right side and the left side of the body, whilst crossing of an obstacle.	At inclusion
Secondary	Time needed for crossing an obstacle	Time needed to cross the obstacle is measured	At inclusion
Secondary	Sitting/standing up alternance	Time in seconds is recorded to measure necessary time from the sitting position up to standing position.	At inclusion
Secondary	Body mass measurement by impedancemetry	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.	At three months
Secondary	Body mass measurement by Dual Energy X-Ray Absorptiometry	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.	At three months
Secondary	Nutrition	Evolution of Body Weight is measured in kg	At inclusion, three, six and twelve months
Secondary	Functionality	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).	At inclusion, three and twelve months
Secondary	Functionality	Lawton scores (IADL - Instrumental Activities of Daily Living)	At inclusion, three and twelve months
Secondary	Echography of Muscles	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.	At inclusion, three, six and twelve months
Secondary	Falls	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.	At inclusion, 4 weeks, three, six, twelve months