PREPA PREvention of Loss of Autonomy

NAActive, not recruitingINTERVENTIONAL
Enrollment

530

Participants

Timeline

Start Date

July 10, 2018

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Mobility LimitationPhysical Activity
Interventions
DIAGNOSTIC_TEST

Multidimensional assessments

"Evaluation carried out during a day hospital at T0 (initial assessment) and T3 following the exercise program including:~1. Clinical assessment by a geriatrician~2. Nutritional assessment~3. Physical capacity assessment~Following initial assessment (T0), older adults are included in the multicomponent exercise program if they present mobility disability risk factors including :~* At least pre-frailty regarding Fried frailty criteria AND/OR~* At least probable sarcopenia regarding EWGSOP2 algorithm AND/OR~* The presence of at least an intermediate fall risk AND/OR~* The presence of a fear of falling Following the exercise program (T3), all participants are re-assessed in the same way as T0. Investigators then set goals in physical activity with participants to maintain benefits and foster self-engagement in an healthy lifestyle. Additionnally, participants are orientated to exercise facilities and received an individualized booklet of exercises for home-based training."

OTHER

Multicomponent group-based and supervised exercise program

The intervention consists in a progressive multicomponent exercise training protocol. There are 2 sessions per week of 1 hour each for a total of 12 weeks. Sessions involve functional, resistance and balance exercises. Intensity is based on rating perceived effort (Borg's scale CR1-10) and volume towards 1 to 3 sets of 6 to 15 repetitions. Progressiveness in intensity and volume was based on effort tolerance, contraction regimen, velocity and load. Training schedule is described elsewhere (Delaire et al, 2023 ; doi.org/10.3390/nu15194100). Participants are allocated to an homogenous group based on functional status and cardiorespiratory comorbidities. Trained kinesiologists supervised the exercise program. Participants used free weights and elastic bands.

OTHER

Follow-up at T3 + 6 months and T3 + 12 months

"Follow-up at T3+6 months:~Investigators interviewed participants for 30 minutes. During the interview, data collection include:record of undesirable events in the interval T3 / T3+6 (falls, unscheduled hospitalization, illness, institutionalization), medication changes, ADL, IADL, FES-I, and RAPA. Goal-settings at T3 are adjusted if not reach. Finally, investigators stimulate intrinsic motivation for PA.~Follow-up at T3 + 12 months:~Investigators re-assessed physical capacity, physical activity level, quality of life, fall risk and frailty for the last visit. Data collection include:~* SPPB~* Handgrip test and maximal isometric strength of the quadriceps~* Questionnaires : SarQoL©, FES-I, RAPA~* Gait quality analysis using inertial sensors~* Undesirable events in the interval T3+6 / T3+12 (falls, unscheduled hospitalization, illness, institutionalization)~* Medication changes~* Body mass index~* ADL and IADL At last, goals in physical activity are adjusted if they are still not reach"

Trial Locations (1)

69495

Service de Médecine Gériatrique Groupement Hospitalier Sud, Pierre-Bénite

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT03667664 - PREPA PREvention of Loss of Autonomy | Biotech Hunter | Biotech Hunter