PREPA PREvention of Loss of Autonomy

NCT ID: NCT03667664

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-10
• Study Completion Date: 2025-10-31

Brief Summary

According to several reports, the proportion of people aged 80yrs or older will be doubled within the next 25y, reaching 10% of the global population. Furthermore, the health life expectancy at 65y is 10.4y which remains much lower than the general life expectancy. As a result, there is a constant need of developing preventive strategies through multimodal programs.

Among the predictive factors of mobility disability with age, muscular weakness and decreased physical function are major components. These two factors are known of being responsible for falls and fractures that lead to decrease the quality of life and an increase in mortality.

Exercise and nutrition are the only components that have proven their efficacy to struggle mobility disability risk. It is important to integrate these two components in a sustained intervention within a multidimensional prevention program. However, there is a lack of implementation of these programs in primary care.

Indeed, neither the screening of older adults at risk of mobility disability, nor the preventive actions are usually implemented for this population. The implementation of a prevention care pathway, with personalized intervention and a sustained follow-up, along with supervised exercise training combined with nutritional counselling, is the public health imperatives.

Based on prevention care pathway that designed for community-dwelling older adults screened at risk of mobility disability. The purpose of this open cohort study was to highlight the efficacy and the feasibility of a multimodal program implemented on real-life setting specifically on the physical function and risk of mobility loss, along with their maintenance at 6-months and 1-year follow-up.

Conditions

Mobility Limitation; Physical Activity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Multicomponent group-based supervised exercise program

Community-dwelling older adults aged of \>70y, screened at risk of mobility disability risk factors and assessed with at least 1 mobility disability risk factor (see intervention 1). These subjects are included in the protocol and participate in a multicomponent exercise program.

Group Type: OTHER

Multidimensional assessments

Intervention Type: DIAGNOSTIC_TEST

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.

Multicomponent group-based and supervised exercise program

Intervention Type: OTHER

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.

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient eligible for the "mobility loss prevention" program
• At least one of the following signs:

• Difficulty carrying a loaded shopping basket (about 4.5 kg)
• Difficulty rising from a chair without using the arms
• Difficulty climbing one flight of stairs (10 steps)
• Difficulty moving around
• Slowed walking
• Difficulty walking more than 400 meters without stopping
• Walking time < 30 minutes/day
• Fatigue during mild physical efforts: running errands, household chores; fear of falling and/or at least one fall in the past year
• Recent unintentional weight loss: weight loss ≥ 5% in 6 months or BMI < 22 kg/m²

Exclusion Criteria

• Patient who has not given consent to participate
• Patient under guardianship in retrospective phase
• Locomotor disability
• expectancy of life being under 12 months
• BMI ≥ 35 Kg/m2

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Médecine Gériatrique Groupement Hospitalier Sud

Pierre-Bénite, , France

Countries

France

Other Identifiers

69HCL16_0324

Identifier Type: -

Identifier Source: org_study_id