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. (PRICA-POWFRAIL)

December 6, 2023 updated by: Alejandro Galán Mercant, University of Cadiz
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 99 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDUcation
The EDU group will assist to an individualized educative program based on intrinsic capacity optimization through lifestyle changes.
Behavioral: EDUcation
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.
Other Names:
  • EDU
Experimental: EXERcise
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
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.
Other Names:
  • EXER
Experimental: EDU-EXER
EDU-EXER group subject develops both interventions together.
Other: EDU-EXER
This group will carry out the same two previous interventions together.
Active Comparator: CONtrol
CON group will continue the usual clinical treatment and their normal life.
Other: CONtrol
CONtrol group will continue the usual clinical treatment and their normal life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative lower limbs muscle power
Time Frame: Change from Baseline STS muscle power at 12 weeks

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
Time Frame: Change from Baseline Vital functional capacity at 12 weeks
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
Time Frame: Change from Baseline Level of physical activity at 12 weeks
Measured by accelerometry for 1 week in evaluation timepoints.
Change from Baseline Level of physical activity at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of life (QoL)
Time Frame: Change from Baseline the quality of life at 12 weeks
EQ-5D which measures health-related QoL through physical, psychological and social dimensions.
Change from Baseline the quality of life at 12 weeks
Subjective health-status level
Time Frame: Change from Baseline the health status level at 12 weeks
SF-36 questionnaire which measures the subjective health-status level.
Change from Baseline the health status level at 12 weeks
Cognitive Function - Mini-mental state examination (MMSE)
Time Frame: Change from Baseline MMSE at 12 weeks
The mini-mental test is a simple test that allows detecting the presence of cognitive impairment, that is, of dementia. It can be normal in people with mild cognitive impairment or with incipient forms of Alzheimer's requiring, in these cases, studies with more sophisticated tests.
Change from Baseline MMSE at 12 weeks
Cognitive Function - The Montreal cognitive assessment test (MoCA)
Time Frame: Change from Baseline MoCA at 12 weeks
The Montreal cognitive assessment test (MoCA) is a brief instrument with which, in a specific way, mild cognitive impairment is detected, as well as dementia.
Change from Baseline MoCA at 12 weeks
Mood State - Geriatric Depression Scale (GDS)
Time Frame: Change from Baseline Geriatric Depression Scale (GDS) at 12 weeks
The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults. Users respond in a "Yes/No" format. The GDS was originally developed as a 30-item instrument. Since this version proved both time-consuming and difficult for some patients to complete, a 15-item version was developed.
Change from Baseline Geriatric Depression Scale (GDS) at 12 weeks
Nutritional profile measurements - Mediterranean Diet Adherence Screener index
Time Frame: Change from Baseline Nutritional profile at 12 weeks
1. MEDAS (Mediterranean Diet Adherence Screener index). Scale of adherence to the Mediterranean diet of 14 items.
Change from Baseline Nutritional profile at 12 weeks
Degree of frailty - Fried criteria
Time Frame: Change from Baseline frailty degree at 12 weeks
The Fried frailty phenotype (FP) assesses physical frailty through five criteria: unintentional weight loss; weakness or poor handgrip strength; self-reported exhaustion; slow walking speed; and low physical activity.
Change from Baseline frailty degree at 12 weeks
Body composition - Bioimpedance
Time Frame: Change from Baseline Bioimpedance composition at 12 weeks
The body composition will be evaluated by means of bioimpedance.
Change from Baseline Bioimpedance composition at 12 weeks
Body composition - body mass index (BMI)
Time Frame: Change from Baseline body mass index (BMI) at 12 weeks
Weight and height will be combined to report BMI in kg/m^2
Change from Baseline body mass index (BMI) at 12 weeks
Body composition - height
Time Frame: Change from Baseline height at 12 weeks
Height measure in meter
Change from Baseline height at 12 weeks
Body composition - weight
Time Frame: Change from Baseline weight at 12 weeks
Weight measure in kilograms
Change from Baseline weight at 12 weeks
Musculoskeletal ultrasound architecture
Time Frame: Change from Baseline Musculoskeletal ultrasound architecture at 12 weeks

All ultrasound images will be acquired by the same operator with the same ultrasound device throughout the whole study using a linear 40 mm transducer and a phased array transductor, and images will be analysed through the ACSAuto script to semi-automatically evaluate ultrasound pictures. The vastus lateralis architecture will be analysed through the Simple Muscle Architecture Analysis tool for Fiji. These procedures will be done according to Rodriguez-López et al.

Rodriguez-Lopez, C. et al. Effects of Power-Oriented Resistance Training With Heavy vs. Light Loads on Muscle-Tendon Function in Older Adults: A Study Protocol for a Randomized Controlled Trial. Front Physiol 12, (2021).
Change from Baseline Musculoskeletal ultrasound architecture at 12 weeks
Depressive Symptoms
Time Frame: Change from Baseline Depressive Symptoms at 12 weeks
The depressive symptoms will be assessed with the Geriatric Depression scale to assess psychology status of the participants.
Change from Baseline Depressive Symptoms at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cadiz

Investigators

  • Principal Investigator: Alejandro Galan-Mercant, PhD, University of Cádiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR2022-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available in an open repository. RODIN is the Repository of Teaching and Research Objects of the University of Cádiz. It contributes to increased visibility of work developed, increases the impact and ensures the preservation of said production. All ethics aspects will be considered to ensure confidentiality of the data as detailed. The University of Cadiz has a new "hybrid cloud" infrastructure, made up of the University of Cadiz's own cloud, combined with others external providers. This service provides secure, efficient and reliable storage, which safeguards the necessary guarantees for autonomy, security and control over the data. Each researcher has an internal space of 500 GB, and an external cloud space of 250 GB. As for backup systems, the one offered by the UCA includes full copies of the space 3 times a week, while external providers have their own backup system, which allows restoring any accidentally deleted information up to 20 days after the incident.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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