Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT03667664 Statut inconnu

Titre

Prevention Study, on Loss of Autonomy and Physical Dependence, Based on Physical Exercises and Nutrition Counseling Applied to 70 Years Old and More People. (PREPA)

Type

Interventional

Pathologie

Mobilité réduite

Phase

N/A

Promoteur

Hospices Civils de Lyon (Voir sur ClinicalTrials)

Date de début

juillet 2018

Date de fin

juillet 2023

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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). Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Service de Médecine Gériatrique Groupement Hospitalier Sud - 69495 - Pierre-Bénite - France	Marc BONNEFOY, PU-PH	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT03667664 - Prevention Study, on Loss of Autonomy and Physical Dependence, Based on Physical Exercises and Nutrition Counseling Applied to 70 Years Old and More People. (PREPA)

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