Viability of an Educational Program for Lifestyle Changes and an Algorithm for the Derivation of Exercise Programs in Older People at Risk of Dependency at Primary Care.

NCT05772910 | Unknown DMC

• 1 other identifier: PR2022-018
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

According to the INE in 2021, more than 9 million people are currently over 65 years of age. This means that more than 1 million are frail and almost 4 million are pre-fragile only in Spain. Frailty is the prelude to disability and dependency, but unlike these, it is treatable and preventable. Currently, it is known that the best treatment for frailty is physical exercise and physical activity. The problem arises from the need that exists in the health system to prescribe individualized and patient-centered exercise, with the use of scarce resources (time, personnel, tools) and in a simple way in clinical practice. Additionally, the system needs tools that help us know (and predict) if this exercise prescription is efficient. Furthermore, frailty is a multidimensional syndrome, for which a comprehensive approach is necessary. The combined study of blood and digital biomarkers, as well as the plethora of dimensions evaluated (muscle and physical activity, cognitive, lifestyle, clinical, body composition, social, sleep), constitute an optimal approach that would provide a unique opportunity to understand prevention and treatment of unsuccessful aging and frailty. The PRICA-POWFRAIL project aims to examine the feasibility of an educational intervention to change lifestyle habits as well as the effect of a referral algorithm to an exercise program and lifestyle changes focused on treating specific deficits of low muscle power, powerful predictor of adverse health events. The subsequent referral will be implemented in a supervised exercise program at the functional, cognitive muscle level and in older people at risk of dependence. Secondarily, the effect of this intervention on blood biomarkers (at a genetic, epigenetic and metabolomic level), physical health (functional capacity, blood pressure, body composition) and mental health (quality of life and depression), as well as on other risk factors (genetic and biological) for the development of frailty. A total of 110 people older than 70 years of age in previous stages of dependency will be randomly distributed among the group of an educational program, the intervention group with supervised physical exercise, a intervention group with both previous educational and exercise programs and the control group. The design will include a 10- week intervention with pre and post-intervention measurement phases and a third measurement (retest) 12 months after completion. The supervised physical exercise program will be of a multi-component type including cardiovascular, muscular, coordinative and balance work, and a progression will be established in the different load parameters (frequency, volume, intensity, density). This will allow us to understand from a very complete perspective the causes and mechanisms underlying this response. The PRICA-POWFRAIL project Will mean a significant increase in scientific knowledge about the response and response rate to ultra-individualized exercise programs directed as a therapeutic measure in people at risk of dependency from a multidimensional perspective. In addition, the project will have a relevant impact at the social and economic level by transferring the findings of the study to the social and health field through the agents and means provided in it.

Conditions

Frailty; Disability Physical; Old Age; Atrophy

Keywords

Education; Physical Exercise; Aging; Frailty; Dependency; Biomarkers; Older Adults; Machine Learning

Outcome Measures

Primary Outcomes (3)

• Relative lower limbs muscle power

  The STS muscle power test was used to assess mechanical power. Participants were instructed to perform 5 timed STS repetitions after the cue "ready, set, go!", as fast as possible, on a standardized armless chair (height = 0.43 m) with arms crossed over the chest. Importantly, from the sitting position, they had to fully extend their knees and hips to the standing position, and descend to the sitting position until at least touching the chair with their buttocks. The test was repeated when any of these instructions was broken. The time (±0.01 s) needed to perform 5 STS repetitions was recorded using a stopwatch. Absolute STS muscle power (W) was calculated using an equation where body mass is indicated in kg, body height and chair height in m, and five STS time in s (Alcazar et al. 2018). Alcazar, J. et al. The sit-to-stand muscle power test: An easy, inexpensive and portable procedure to assess muscle power in older people. Exp Gerontol 112, 38-43 (2018).

  Change from Baseline STS muscle power at 12 weeks

• Vital functional capacity

  The vital functional capacity will be evaluated through cardiorespiratory function using an indirect test adapted to the age range (field tests, which allow obtaining an estimated value of maximum oxygen consumption, the best integral marker of the physiological reserve of an individual, namely 6minute walking test or the 2 min-version which is highly correlated.

  Change from Baseline Vital functional capacity at 12 weeks

• Level of physical activity during the daily life

  Measured by accelerometry for 1 week in evaluation timepoints.

  Change from Baseline Level of physical activity at 12 weeks

Secondary Outcomes (13)

• The quality of life (QoL)

  Change from Baseline the quality of life at 12 weeks

• Subjective health-status level

  Change from Baseline the health status level at 12 weeks

• Cognitive Function - Mini-mental state examination (MMSE)

  Change from Baseline MMSE at 12 weeks

• Cognitive Function - The Montreal cognitive assessment test (MoCA)

  Change from Baseline MoCA at 12 weeks

• Mood State - Geriatric Depression Scale (GDS)

  Change from Baseline Geriatric Depression Scale (GDS) at 12 weeks

Study Arms (4)

EDUcation

EXPERIMENTAL

The EDU group will assist to an individualized educative program based on intrinsic capacity optimization through lifestyle changes.

Behavioral: EDUcation

EXERcise

EXPERIMENTAL

The EXER group will follow a program focused on the specific deficit of muscular power from a simple clinical test such as the STS and, in addition, they will be evaluated to be able to prescribe training individually (evaluation of training)

Other: EXERcise

EDU-EXER

EXPERIMENTAL

EDU-EXER group subject develops both interventions together.

Other: EDU-EXER

CONtrol

ACTIVE COMPARATOR

CON group will continue the usual clinical treatment and their normal life.

Other: CONtrol

Interventions

EDUcation BEHAVIORAL

The education intervention will consist of an individualized educative program based on intrinsic capacity optimization through lifestyle changes. To develop the program, the program creation team will be multidisciplinary (psychologists, medical doctor, dietitian…) and will discuss goal setting, the education strategy, and retention of motivation. The experts are required to create the education program such that the participants can manage their health by themselves. The goal will be self-management of dietary habits and increases in physical activity levels for each individual case. The education program will be in Spanish or in English; as it will consist in personal counselling, even with a low level of the language the communication will be possible. The nutritional education program will be conducted every 2 weeks for 10 consecutive weeks, with 20-min counselling sessions by an expert.

Also known as: EDU

EDUcation

EXERcise OTHER

The intervention period will have 10 weeks, in which the EXER group will carry out 2-3 sessions a week (total of 20-30 sessions). In this concurrent program, exercises of the lower extremities (leg press, abduction and plantar flexion) will be performed mainly on weight training machines. Intensity in each exercise will be individualized for each participant through a test to determine muscle power. In addition, in the last part of each session the participants will perform an endurance training type high insensitive interval training on a cycle ergometer (60-80 rpm). The intensity will be individualized to each patient through an incremental stress test until volitional exhaustion, and the subjects will alternate intervals of 30 seconds at 90% of the maximum workload, with intervals of 90 seconds at 40% of the maximum. Each session is estimated to have a total duration of 30-50 minutes.

Also known as: EXER

EXERcise

EDU-EXER OTHER

This group will carry out the same two previous interventions together.

EDU-EXER

CONtrol OTHER

CONtrol group will continue the usual clinical treatment and their normal life

CONtrol

Eligibility Criteria

• Age: 70 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Following the 2014 Consensus Document on the prevention of frailty and falls in the elderly patient we will recruit individuals
• I) \> 70 years of age
• II) with a Barthel Index score \> 75
• III) meeting at least one of the following two criteria: a score ≤9 in the short physical performance battery (SPPB) or FRAIL questionnaire with values 1 or 2.

You may not qualify if:

• I) Inability to go to the Primary Care Health Centre for any reason.
• II) Moderate to severe cognitive impairment (Mini-Mental State Examination\< 20 points
• III) Severe pathology for which physical activity is contraindicated at the physician's discretion including but not limited to: recent acute myocardial infarction (6 months), uncontrolled cardiac arrhythmia, severe cardiac valve disease, non-controlled hypertension (\> 180/100mmHg), non-controlled/severe heart failure, severe respiratory insufficiency disease, and diabetes mellitus with acute decompensation/frequent hypoglycaemia.

Sponsors & Collaborators

• University of Cadiz: lead

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MeSH Terms

Conditions

Frailty; Atrophy; Motor Activity

Interventions

Educational Status; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alejandro Galan-Mercant, PhD

  University of Cádiz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Galan-Mercant, PhD

CONTACT

0034 667972031; alejandro.galan@uca.es

Daniel Velazquez-Diaz, PhD

CONTACT

0034 610035133; daniel.velazquez@uca.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 16, 2023
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP