FrailtyPRICA-POWFRAILNCT05772910
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.
A study testing EDUcation, EXERcise and EDU-EXER in people with Frailty and Disability Physical, run by University of Cadiz.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 99 years
- Conditions the study is for
- Frailty, Disability Physical, Old Age; Atrophy
- What is being tested?
- EDUcation, EXERcise and EDU-EXER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Following the 2014 Consensus Document on the prevention of frailty and falls in the elderly patient we will recruit individuals
- > 70 years of age
- with a Barthel Index score > 75
- 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.
Who cannot join
- Inability to go to the Primary Care Health Centre for any reason.
- Moderate to severe cognitive impairment (Mini-Mental State Examination< 20 points
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- EDUcation, EXERcise, EDU-EXER, CONtrol
- Keywords
- Education, Physical Exercise, Aging, Frailty, Dependency, Biomarkers, Older Adults, Machine Learning
- Medical subject headings
- Frailty, Atrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDUcationBehavioural
Also called EDU
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.
EXERciseOther
Also called EXER
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.
EDU-EXEROther
This group will carry out the same two previous interventions together.
CONtrolOther
CONtrol group will continue the usual clinical treatment and their normal life
| Study group | Role | What they receive |
|---|---|---|
| EDUcation | Experimental | The EDU group will assist to an individualized educative program based on intrinsic capacity optimization through lifestyle changes. Receives: 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) Receives: Other: EXERcise |
| EDU-EXER | Experimental | EDU-EXER group subject develops both interventions together. Receives: Other: EDU-EXER |
| CONtrol | Active comparator | CON group will continue the usual clinical treatment and their normal life. Receives: Other: CONtrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Change from Baseline Level of physical activity at 12 weeks
Secondary outcomes (13)
The quality of life (QoL)
EQ-5D which measures health-related QoL through physical, psychological and social dimensions.
Measured: Change from Baseline the quality of life at 12 weeks
Subjective health-status level
SF-36 questionnaire which measures the subjective health-status level.
Measured: Change from Baseline the health status level at 12 weeks
Cognitive Function - Mini-mental state examination (MMSE)
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.
Measured: Change from Baseline MMSE at 12 weeks
Cognitive Function - The Montreal cognitive assessment test (MoCA)
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.
Measured: Change from Baseline MoCA at 12 weeks
Mood State - Geriatric Depression Scale (GDS)
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.
Measured: Change from Baseline Geriatric Depression Scale (GDS) at 12 weeks
Nutritional profile measurements - Mediterranean Diet Adherence Screener index
- MEDAS (Mediterranean Diet Adherence Screener index). Scale of adherence to the Mediterranean diet of 14 items.
Measured: Change from Baseline Nutritional profile at 12 weeks
Degree of frailty - Fried criteria
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.
Measured: Change from Baseline frailty degree at 12 weeks
Body composition - Bioimpedance
The body composition will be evaluated by means of bioimpedance.
Measured: Change from Baseline Bioimpedance composition at 12 weeks
Body composition - body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2
Measured: Change from Baseline body mass index (BMI) at 12 weeks
Body composition - height
Height measure in meter
Measured: Change from Baseline height at 12 weeks
Body composition - weight
Weight measure in kilograms
Measured: Change from Baseline weight at 12 weeks
Musculoskeletal ultrasound architecture
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).
Measured: Change from Baseline Musculoskeletal ultrasound architecture at 12 weeks
Depressive Symptoms
The depressive symptoms will be assessed with the Geriatric Depression scale to assess psychology status of the participants.
Measured: Change from Baseline Depressive Symptoms at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Sep 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Galán Mercant, University of Cadiz
- Investigators
- Alejandro Galan-Mercant, PhD, Principal investigator, University of Cádiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772910
- Sponsor's protocol ID
- PR2022-018
- Acronym
- PRICA-POWFRAIL
- Status last verified
- Dec 2023
- First submitted
- 22 Feb 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Lowry KA, Vallejo AN, Studenski SA. Successful aging as a continuum of functional independence: lessons from physical disability models of aging. Aging Dis. 2012 Feb;3(1):5-15. Epub 2011 Aug 15.
PubMed 22500268Garcia-Garcia FJ, Larrion Zugasti JL, Rodriguez Manas L. [Frailty: a phenotype under review]. Gac Sanit. 2011 Dec;25 Suppl 2:51-8. doi: 10.1016/j.gaceta.2011.08.001. Epub 2011 Oct 26. Spanish.
PubMed 22033007Tavassoli N, Piau A, Berbon C, De Kerimel J, Lafont C, De Souto Barreto P, Guyonnet S, Takeda C, Carrie I, Angioni D, Paris F, Mathieu C, Ousset PJ, Balardy L, Voisin T, Sourdet S, Delrieu J, Bezombes V, Pons-Pretre V, Andrieu S, Nourhashemi F, Rolland Y, Soto ME, Beard J, Sumi Y, Araujo Carvalho I, Vellas B. Framework Implementation of the INSPIRE ICOPE-CARE Program in Collaboration with the World Health Organization (WHO) in the Occitania Region. J Frailty Aging. 2021;10(2):103-109. doi: 10.14283/jfa.2020.26.
PubMed 33575698Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. The hallmarks of aging. Cell. 2013 Jun 6;153(6):1194-217. doi: 10.1016/j.cell.2013.05.039.
PubMed 23746838Warming L, Hassager C, Christiansen C. Changes in bone mineral density with age in men and women: a longitudinal study. Osteoporos Int. 2002;13(2):105-12. doi: 10.1007/s001980200001.
PubMed 11905520Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014 Jun 18;311(23):2387-96. doi: 10.1001/jama.2014.5616.
PubMed 24866862Berryman JW. Exercise is medicine: a historical perspective. Curr Sports Med Rep. 2010 Jul-Aug;9(4):195-201. doi: 10.1249/JSR.0b013e3181e7d86d.
PubMed 20622536Cadore EL, Izquierdo M. Exercise interventions in polypathological aging patients that coexist with diabetes mellitus: improving functional status and quality of life. Age (Dordr). 2015 Jun;37(3):64. doi: 10.1007/s11357-015-9800-2. Epub 2015 Jun 9.
PubMed 26054595Izquierdo M, Rodriguez-Manas L, Casas-Herrero A, Martinez-Velilla N, Cadore EL, Sinclair AJ. Is It Ethical Not to Precribe Physical Activity for the Elderly Frail? J Am Med Dir Assoc. 2016 Sep 1;17(9):779-81. doi: 10.1016/j.jamda.2016.06.015. Epub 2016 Jul 28. No abstract available.
PubMed 27477615Ahtiainen JP, Walker S, Peltonen H, Holviala J, Sillanpaa E, Karavirta L, Sallinen J, Mikkola J, Valkeinen H, Mero A, Hulmi JJ, Hakkinen K. Heterogeneity in resistance training-induced muscle strength and mass responses in men and women of different ages. Age (Dordr). 2016 Feb;38(1):10. doi: 10.1007/s11357-015-9870-1. Epub 2016 Jan 15.
PubMed 26767377Bonafiglia JT, Rotundo MP, Whittall JP, Scribbans TD, Graham RB, Gurd BJ. Inter-Individual Variability in the Adaptive Responses to Endurance and Sprint Interval Training: A Randomized Crossover Study. PLoS One. 2016 Dec 9;11(12):e0167790. doi: 10.1371/journal.pone.0167790. eCollection 2016.
PubMed 27936084Pickering, C. & Kiely, J. Understanding Personalized Training Responses: Can Genetic Assessment Help? Open Sports Sci. 2017; J 10, 191-213.
Sarzynski MA, Ghosh S, Bouchard C. Genomic and transcriptomic predictors of response levels to endurance exercise training. J Physiol. 2017 May 1;595(9):2931-2939. doi: 10.1113/JP272559. Epub 2016 Jul 3.
PubMed 27234805Delmonico MJ, Kostek MC, Doldo NA, Hand BD, Walsh S, Conway JM, Carignan CR, Roth SM, Hurley BF. Alpha-actinin-3 (ACTN3) R577X polymorphism influences knee extensor peak power response to strength training in older men and women. J Gerontol A Biol Sci Med Sci. 2007 Feb;62(2):206-12. doi: 10.1093/gerona/62.2.206.
PubMed 17339648Charbonneau DE, Hanson ED, Ludlow AT, Delmonico MJ, Hurley BF, Roth SM. ACE genotype and the muscle hypertrophic and strength responses to strength training. Med Sci Sports Exerc. 2008 Apr;40(4):677-83. doi: 10.1249/MSS.0b013e318161eab9.
PubMed 18317377
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05772910
- Acronym / sponsor ID
- PRICA-POWFRAIL / PR2022-018
- Conditions
- Frailty, Disability Physical, Old Age; Atrophy
- Keywords
- Education, Physical Exercise, Aging, Frailty, Dependency, Biomarkers, Older Adults, Machine Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| EDUcation | Experimental | Behavioral: EDUcationThe EDU group will assist to an individualized educative program based on intrinsic capacity optimization through lifestyle changes. |
| EXERcise | Experimental | Other: EXERciseThe 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) |
| EDU-EXER | Experimental | Other: EDU-EXEREDU-EXER group subject develops both interventions together. |
| CONtrol | Active comparator | Other: CONtrolCON group will continue the usual clinical treatment and their normal life. |
Who may qualify
- Ages
- 70 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Following the 2014 Consensus Document on the prevention of frailty and falls in the elderly patient we will recruit individuals
- > 70 years of age
- with a Barthel Index score > 75
- 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.
Key exclusion criteria (3 listed)
- Inability to go to the Primary Care Health Centre for any reason.
- Moderate to severe cognitive impairment (Mini-Mental State Examination< 20 points
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDUcationAlso: EDUThe 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. | Behavioural | EDUcation |
| EXERciseAlso: EXERThe 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 | EXERcise |
| EDU-EXERThis group will carry out the same two previous interventions together. | Other | EDU-EXER |
| CONtrolCONtrol group will continue the usual clinical treatment and their normal life | Other | CONtrol |
Primary outcome
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).
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.
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.
13 secondary outcomes
The quality of life (QoL)
Time frame: 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
Cognitive Function - Mini-mental state examination (MMSE)
Time frame: Change from Baseline MMSE at 12 weeks
Cognitive Function - The Montreal cognitive assessment test (MoCA)
Time frame: 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
Nutritional profile measurements - Mediterranean Diet Adherence Screener index
Time frame: Change from Baseline Nutritional profile at 12 weeks
Degree of frailty - Fried criteria
Time frame: Change from Baseline frailty degree at 12 weeks
Body composition - Bioimpedance
Time frame: 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
Body composition - height
Time frame: Change from Baseline height at 12 weeks
Body composition - weight
Time frame: Change from Baseline weight at 12 weeks
Musculoskeletal ultrasound architecture
Time frame: Change from Baseline Musculoskeletal ultrasound architecture at 12 weeks
Depressive Symptoms
Time frame: Change from Baseline Depressive Symptoms at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 22500268Lowry KA, Vallejo AN, Studenski SA. Successful aging as a continuum of functional independence: lessons from physical disability models of aging. Aging Dis. 2012 Feb;3(1):5-15. Epub 2011 Aug 15.
- Background: PubMed 22033007Garcia-Garcia FJ, Larrion Zugasti JL, Rodriguez Manas L. [Frailty: a phenotype under review]. Gac Sanit. 2011 Dec;25 Suppl 2:51-8. doi: 10.1016/j.gaceta.2011.08.001. Epub 2011 Oct 26. Spanish.
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- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Galan-Mercant, PhD principal investigator
University of Cádiz
Questions about this trial
What is this clinical trial studying?
A study testing EDUcation, EXERcise and EDU-EXER in people with Frailty and Disability Physical, run by University of Cadiz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Galan-Mercant, PhD (0034 667972031, alejandro.galan@uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative lower limbs muscle power (time frame: Change from Baseline STS muscle power at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05772910, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.