PREPA PREvention of Loss of Autonomy

Not Applicable

Active, not recruiting

• Conditions: Mobility Limitation; Physical Activity

• Registration Number: NCT03667664
• Lead Sponsor: Hospices Civils de Lyon

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.

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).

Study Timeline

• Study First Submitted: 2018-01-29
• Study Start: 2018-07-10
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-09
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 530

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Functional status	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of sarcopenia : EWGSOP2	initial assessment (baseline), following the exercise program (month 3)	No sarcopenia = muscle strength and mass normal Probable sarcopenia = low muscle strength, normal muscle mass Sarcopenia = low muscle strength and mass Severe sarcopenia = low muscle strength and mass + poor physical performances
Evaluation of nutritional status : Mini Nutritional Assessment	initial assessment (baseline), following the exercise program (month 3)	This self-administrated questionnaire consists of 18 questions. Score varies from 0 to 30. From 17 to 24 points : risk of malnutrition Less than 17 points : poor nutritional status
Evaluation of nutritional status : caloric (kcal) needs and intakes from the dietary survey	initial assessment (baseline), following the exercise program (month 3)	Survey is self-administrated. Needs/Intake are calculated based on the survey.
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)	The subject has to perform 3 maximum isometric muscular contractions separately against a dynamometer. The best performance (i.e. greatest strength measure) is collected.
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)	The subject has to stand with knee extended and sit from a chair 5 times without stopping
Evaluation of effectiveness on functional status : Time in TUG (s)	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	The subject must get up from a chair, walk at usual speed 3 meters, turn around, and sit down again. A value greater than or equal to 20 seconds will be considered abnormal.
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)	Estimation of lower limb muscle power based on the mean of the 3 repetitions of a sit-to-stand test perform separately. For each transfer, the lifting index (as a % of body weight), reaction time (s), the oscillation limit of the center of gravity, and the symmetry of the supports are measured
Evaluation of effectiveness on muscle strength : Handgrip test (kg)	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	The subject has to perform 3 maximum isometric contractions on a dynamometer which records the force developed. The average of these 3 values will be retained. A value lower than \<16kg for women and \<27kg for men are considered abnormal and indicate the presence of probable sarcopenia.
Evaluation of muscle mass : SMI measured by bio-impedance analysis (kg.m2)	initial assessment (baseline), following the exercise program (month 3)	SMI is a relative index which is computed from the Sergi equation. Cut-off points are \<7,0 and \<5,5 for men and women respectively and are considered abnormal. These are the reference values for sarcopenia diagnosis.
Evaluation of muscle mass : Ultrasonography of the vastus lateralis	initial assessment (baseline), following the exercise program (month 3)	Data collection include of fiber length (cm)
Evaluation of dependencies : Katz scale (Activities of Daily Living - ADL)	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	Katz scale (ADL) consists of 6 questions. Score varies from 0 to 6. The lower the score, the more dependant is the patient
Evaluation of effectiveness on functional status : Gait quality analysis using inertial sensors (GaitUp, MindMaze®, Switzerland)	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	A 50 meters walking test perform at usual speed is realized. Data collection include : gait speed, gait variability, gait asymmetry, % flight time, % support time, % double support time, angle of attack, push-off angle, step height, step length, number of cycles in the U-turn, angles in the U-turn
Evaluation of fear of falling : FES-I questionnaire (/64)	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	The validated French translated form is used. Questionnaire is self-administrated.; FES-I questionnaire (Falls Efficacy Scale-International) consists of 16 questions. Score varies from 16 to 64.; A fear of falling is considered to be present with score \>23.
Evolution of the level of physical activity : RAPA questionnaire (/10)	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	The RAPA is validated physical activity questionnaire in older adults. The score is calculated from the reported information of each visit.; Score varies from 0 to 10. The higher the score, the more physically active is the patient.
Evaluation of biomarkers : risk of fractures - Vitamin D (nmol/L).	initial assessment (baseline), following the exercise program (month 3)	initial assessment (baseline), following the exercise program (month 3)
Evaluation of dependencies : Lawton scale (Instrumental Activities of Daily Living-IADL)	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	Lawton scale (IADL) consists of 8 questions. Score varies from 0 to 8. The lower the score, the more dependant is the patient.
Record of undesirable events : Falls, unscheduled hospitalization, illness, institutionalization	initial assessment (baseline), following the exercise program (month 3), 6 months following the exercise program (month 9), last visit (month 15)	Data are collected between intervals : T3/T3+6 and T3+6/T3+12
Evolution of quality of life : SarQoL© questionnaire	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	The SarQoL© is a validated questionnaire in sarcopenic older adults. French validated translated form were used. The questionnaire is self-administrated. An overall change of 7,35 points in the questionnaire is considered to be clinically meaningful.
Evaluation of biomarkers : risk of fractures - Calcemia (mmol/L)	initial assessment (baseline), following the exercise program (month 3)	initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : exploratory Fibroblast Growth Factor 19 (FGF-19) (pg/L)	initial assessment (baseline), following the exercise program (month 3)	FGF-19 is analysed in plasma samples by ELISA method. Blood sample is collected in routine care.
Evaluation of biomarkers : nutritional status - Albumin (g/L)	initial assessment (baseline), following the exercise program (month 3)	Albumin (g/L)
Evaluation of biomarkers : nutritional status - Pre-albumin (g/L)	initial assessment (baseline), following the exercise program (month 3)	Pre-albumin (g/L)
Evaluation of physical frailty : Fried criteria	initial assessment (baseline), following the exercise program (month 3), last visit (month 15)	Fried criteria include : unvolontary weight loss \>5% during the last 12 months, self-reported exhaustion, low gait speed, low grip strength and poor physical activity level. 0 criterion = non frail ; 1-2 criteria = pre-frail ; ≥3 criteria = frail
Evaluation of biomarkers : inflammation C-reactive protein	initial assessment (baseline), following the exercise program (month 3)
Evaluation of nutritional status : protein (g/J) needs and intakes from the dietary survey	initial assessment (baseline), following the exercise program (month 3)	Survey is self-administrated. Needs/Intake are calculated based on the survey.

Trial Locations

Locations (1)

Service de Médecine Gériatrique Groupement Hospitalier Sud; 🇫🇷 Pierre-Bénite, France