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PREPA PREvention of Loss of Autonomy (PREPA)

Primary Purpose

Mobility Limitation, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical exercises et nutritional counseling in elderly people at risks of loss of autonomy
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mobility Limitation focused on measuring Autonomy, Elderly, Physical exercise, Nutrition, Prevention

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service de Médecine Gériatrique Groupement Hospitalier SudRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prevention of loss of autonomy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Knee extension test
The strength of extension muscle starting from the knee is measured from appropriate device, in kg.
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.
Time needed for crossing an obstacle
Time needed to cross the obstacle is measured
Sitting/standing up alternance
Time in seconds is recorded to measure necessary time from the sitting position up to standing position.
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.
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.
Nutrition
Evolution of Body Weight is measured in kg
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).
Functionality
Lawton scores (IADL - Instrumental Activities of Daily Living)
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.
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.

Full Information

First Posted
January 29, 2018
Last Updated
September 11, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03667664
Brief Title
PREPA PREvention of Loss of Autonomy
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Physical Activity
Keywords
Autonomy, Elderly, Physical exercise, Nutrition, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prevention of loss of autonomy
Arm Type
Other
Arm Description
Lifestyle counseling for elderly people about physical exercises and nutrition in a preventive way
Intervention Type
Behavioral
Intervention Name(s)
Physical exercises et nutritional counseling in elderly people at risks of loss of autonomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical functional status
Description
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.
Time Frame
At three months
Secondary Outcome Measure Information:
Title
Physical performance : Hand grip test
Description
Hand grip test measures the strength of the hand gripping the device as strong as possible, and strength is measured in kg.
Time Frame
At three months
Title
Knee extension test
Description
The strength of extension muscle starting from the knee is measured from appropriate device, in kg.
Time Frame
At three months
Title
Body repartition during crossing an obstacle
Description
The percentage of body repartition is evaluated between the right side and the left side of the body, whilst crossing of an obstacle.
Time Frame
At inclusion
Title
Time needed for crossing an obstacle
Description
Time needed to cross the obstacle is measured
Time Frame
At inclusion
Title
Sitting/standing up alternance
Description
Time in seconds is recorded to measure necessary time from the sitting position up to standing position.
Time Frame
At inclusion
Title
Body mass measurement by impedancemetry
Description
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.
Time Frame
At three months
Title
Body mass measurement by Dual Energy X-Ray Absorptiometry
Description
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.
Time Frame
At three months
Title
Nutrition
Description
Evolution of Body Weight is measured in kg
Time Frame
At inclusion, three, six and twelve months
Title
Functionality
Description
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).
Time Frame
At inclusion, three and twelve months
Title
Functionality
Description
Lawton scores (IADL - Instrumental Activities of Daily Living)
Time Frame
At inclusion, three and twelve months
Title
Echography of Muscles
Description
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.
Time Frame
At inclusion, three, six and twelve months
Title
Falls
Description
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.
Time Frame
At inclusion, 4 weeks, three, six, twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc BONNEFOY, PU-PH
Phone
04 78 86 15 81
Ext
+33
Email
marc.bonnefoy@chu-lyon.fr
Facility Information:
Facility Name
Service de Médecine Gériatrique Groupement Hospitalier Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BONNEFOY, PU-PH
Phone
04 78 86 15 81
Ext
+33
Email
marc.bonnefoy@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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PREPA PREvention of Loss of Autonomy

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