PREPA PREvention of Loss of Autonomy

NCT03667664 | Active Not Recruiting

• 1 other identifier: 69HCL16_0324
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

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

Keywords

Autonomy; Elderly; Physical exercise; Nutrition; Prevention

Outcome Measures

Primary Outcomes (1)

• Functional status

  Functional status is assessed using the overall SPPB (Short Physical Performance Battery) score based on three components: 6 meters usual walking speed, 5 repetitions chair stand test, and static balance tests. (composite score /12). The SPPB score is calculate from the results in 3 subtests. It ranges from 1 to 12 points. Clinically meaningful change is 1 point.

  initial assessment (baseline), following the exercise program (month 3), last visit (month 15)

Secondary Outcomes (27)

• Evaluation of effectiveness on muscle strength : Handgrip test (kg)

  initial assessment (baseline), following the exercise program (month 3), last visit (month 15)

• Evaluation of effectiveness on muscle strength : Maximal isometric strength of the quadriceps (kg)

  initial assessment (baseline), following the exercise program (month 3), last visit (month 15)

• Evaluation of effectiveness on functional status : 5 repetitions chair stand test (s)

  initial assessment (baseline), following the exercise program (month 3), last visit (month 15)

• Evaluation of effectiveness on functional status : Time in TUG (s)

  initial assessment (baseline), following the exercise program (month 3), last visit (month 15)

• Evaluation of effectiveness on functional status : Lower body muscle power measured by a one sit-to-stand test perform at maximum speed (Neurocom Balance Master, Medimex®, France)

  initial assessment (baseline), following the exercise program (month 3)

Study Arms (1)

Multicomponent group-based supervised exercise program

OTHER

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.

Diagnostic Test: Multidimensional assessments; Other: Multicomponent group-based and supervised exercise program; Other: Follow-up at T3 + 6 months and T3 + 12 months

Interventions

Multidimensional assessments 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 supervised exercise program

Multicomponent group-based and supervised exercise program 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.

Multicomponent group-based supervised exercise program

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

Multicomponent group-based supervised exercise program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Médecine Gériatrique Groupement Hospitalier Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Mobility Limitation; Motor Activity

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: September 12, 2018
• Study Start: July 10, 2018
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)