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.

Frailty Clinical Trial

— PRICA-POWFRAIL  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05772910
• Other study ID #: PR2022-018
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: December 2023
• Source: University of Cadiz
• Contact: Alejandro Galan-Mercant, PhD
• Phone: 0034 667972031
• Email: alejandro.galan[@]uca.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: February 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disability Physical
• Frailty
• Old Age; Atrophy

Intervention

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:
• 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.
• EDU-EXER
This group will carry out the same two previous interventions together.
• CONtrol
CONtrol group will continue the usual clinical treatment and their normal life

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cadiz

References & Publications (39)

Ahtiainen 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. — View Citation

Alcazar J, Losa-Reyna J, Rodriguez-Lopez C, Alfaro-Acha A, Rodriguez-Manas L, Ara I, Garcia-Garcia FJ, Alegre LM. The sit-to-stand muscle power test: An easy, inexpensive and portable procedure to assess muscle power in older people. Exp Gerontol. 2018 Oct 2;112:38-43. doi: 10.1016/j.exger.2018.08.006. Epub 2018 Sep 1. — View Citation

Alibegovic AC, Sonne MP, Hojbjerre L, Bork-Jensen J, Jacobsen S, Nilsson E, Faerch K, Hiscock N, Mortensen B, Friedrichsen M, Stallknecht B, Dela F, Vaag A. Insulin resistance induced by physical inactivity is associated with multiple transcriptional changes in skeletal muscle in young men. Am J Physiol Endocrinol Metab. 2010 Nov;299(5):E752-63. doi: 10.1152/ajpendo.00590.2009. Epub 2010 Aug 24. — View Citation

Berryman JW. Exercise is medicine: a historical perspective. Curr Sports Med Rep. 2010 Jul-Aug;9(4):195-201. doi: 10.1249/JSR.0b013e3181e7d86d. — View Citation

Bonafiglia 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. — View Citation

Cadore 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. — View Citation

Cannataro R, Carbone L, Petro JL, Cione E, Vargas S, Angulo H, Forero DA, Odriozola-Martinez A, Kreider RB, Bonilla DA. Sarcopenia: Etiology, Nutritional Approaches, and miRNAs. Int J Mol Sci. 2021 Sep 8;22(18):9724. doi: 10.3390/ijms22189724. — View Citation

Chang KV, Chen YC, Wu WT, Shen HJ, Huang KC, Chu HP, Han DS. Expression of Telomeric Repeat-Containing RNA Decreases in Sarcopenia and Increases after Exercise and Nutrition Intervention. Nutrients. 2020 Dec 8;12(12):3766. doi: 10.3390/nu12123766. — View Citation

Charbonneau 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. — View Citation

Cuesta-Vargas AI, Galan-Mercant A, Williams JM. The use of inertial sensors system for human motion analysis. Phys Ther Rev. 2010 Dec;15(6):462-473. doi: 10.1179/1743288X11Y.0000000006. — View Citation

Delmonico 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. — View Citation

Espinosa-Salinas I, de la Iglesia R, Colmenarejo G, Molina S, Reglero G, Martinez JA, Loria-Kohen V, Ramirez de Molina A. GCKR rs780094 Polymorphism as A Genetic Variant Involved in Physical Exercise. Genes (Basel). 2019 Jul 28;10(8):570. doi: 10.3390/genes10080570. — View Citation

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. — View Citation

Galan-Mercant A, Baron-Lopez FJ, Labajos-Manzanares MT, Cuesta-Vargas AI. Reliability and criterion-related validity with a smartphone used in timed-up-and-go test. Biomed Eng Online. 2014 Dec 2;13:156. doi: 10.1186/1475-925X-13-156. — View Citation

Garcia-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. — View Citation

Gruenewald TL, Seeman TE, Karlamangla AS, Sarkisian CA. Allostatic load and frailty in older adults. J Am Geriatr Soc. 2009 Sep;57(9):1525-31. doi: 10.1111/j.1532-5415.2009.02389.x. Epub 2009 Jul 21. — View Citation

Izquierdo 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. — View Citation

Kim M, Walston JD, Won CW. Associations Between Elevated Growth Differentiation Factor-15 and Sarcopenia Among Community-dwelling Older Adults. J Gerontol A Biol Sci Med Sci. 2022 Apr 1;77(4):770-780. doi: 10.1093/gerona/glab201. — View Citation

Liu HC, Han DS, Hsu CC, Wang JS. Circulating MicroRNA-486 and MicroRNA-146a serve as potential biomarkers of sarcopenia in the older adults. BMC Geriatr. 2021 Jan 30;21(1):86. doi: 10.1186/s12877-021-02040-0. — View Citation

Lopez-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. — View Citation

Losa-Reyna J, Alcazar J, Rodriguez-Gomez I, Alfaro-Acha A, Alegre LM, Rodriguez-Manas L, Ara I, Garcia-Garcia FJ. Low relative mechanical power in older adults: An operational definition and algorithm for its application in the clinical setting. Exp Gerontol. 2020 Dec;142:111141. doi: 10.1016/j.exger.2020.111141. Epub 2020 Oct 27. — View Citation

Losa-Reyna J, Baltasar-Fernandez I, Alcazar J, Navarro-Cruz R, Garcia-Garcia FJ, Alegre LM, Alfaro-Acha A. Effect of a short multicomponent exercise intervention focused on muscle power in frail and pre frail elderly: A pilot trial. Exp Gerontol. 2019 Jan;115:114-121. doi: 10.1016/j.exger.2018.11.022. Epub 2018 Dec 4. — View Citation

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. — View Citation

Mateos-Angulo A, Galan-Mercant A, Cuesta-Vargas AI. Muscle thickness contribution to sit-to-stand ability in institutionalized older adults. Aging Clin Exp Res. 2020 Aug;32(8):1477-1483. doi: 10.1007/s40520-019-01328-x. Epub 2019 Aug 28. — View Citation

McCarthy JJ. The MyomiR network in skeletal muscle plasticity. Exerc Sport Sci Rev. 2011 Jul;39(3):150-4. doi: 10.1097/JES.0b013e31821c01e1. — View Citation

McGinley JL, Baker R, Wolfe R, Morris ME. The reliability of three-dimensional kinematic gait measurements: a systematic review. Gait Posture. 2009 Apr;29(3):360-9. doi: 10.1016/j.gaitpost.2008.09.003. Epub 2008 Nov 13. — View Citation

Nawaratne R, Alahakoon D, De Silva D, O'Halloran PD, Montoye AH, Staley K, Nicholson M, Kingsley MI. Deep Learning to Predict Energy Expenditure and Activity Intensity in Free Living Conditions using Wrist-specific Accelerometry. J Sports Sci. 2021 Mar;39(6):683-690. doi: 10.1080/02640414.2020.1841394. Epub 2020 Oct 30. — View Citation

Pahor 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. — View Citation

Picca A, Guerra F, Calvani R, Marini F, Biancolillo A, Landi G, Beli R, Landi F, Bernabei R, Bentivoglio AR, Monaco MRL, Bucci C, Marzetti E. Mitochondrial Signatures in Circulating Extracellular Vesicles of Older Adults with Parkinson's Disease: Results from the EXosomes in PArkiNson's Disease (EXPAND) Study. J Clin Med. 2020 Feb 12;9(2):504. doi: 10.3390/jcm9020504. — View Citation

Pickering C, Kiely J. ACTN3, Morbidity, and Healthy Aging. Front Genet. 2018 Jan 24;9:15. doi: 10.3389/fgene.2018.00015. eCollection 2018. — View Citation

Pickering C, Kiely J. ACTN3: More than Just a Gene for Speed. Front Physiol. 2017 Dec 18;8:1080. doi: 10.3389/fphys.2017.01080. eCollection 2017. — View Citation

Pickering, C. & Kiely, J. Understanding Personalized Training Responses: Can Genetic Assessment Help? Open Sports Sci. 2017; J 10, 191-213.

Rockwood K, Abeysundera MJ, Mitnitski A. How should we grade frailty in nursing home patients? J Am Med Dir Assoc. 2007 Nov;8(9):595-603. doi: 10.1016/j.jamda.2007.07.012. Epub 2007 Oct 22. — View Citation

Rodriguez-Lopez C, Alcazar J, Losa-Reyna J, Martin-Espinosa NM, Baltasar-Fernandez I, Ara I, Csapo R, Alegre LM. 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. 2021 Feb 18;12:635094. doi: 10.3389/fphys.2021.635094. eCollection 2021. — View Citation

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. — View Citation

Semba RD, Gonzalez-Freire M, Tanaka T, Biancotto A, Zhang P, Shardell M, Moaddel R; CHI Consortium; Ferrucci L. Elevated Plasma Growth and Differentiation Factor 15 Is Associated With Slower Gait Speed and Lower Physical Performance in Healthy Community-Dwelling Adults. J Gerontol A Biol Sci Med Sci. 2020 Jan 1;75(1):175-180. doi: 10.1093/gerona/glz071. — View Citation

Tavassoli 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. — View Citation

Tseng SH, Lee WJ, Peng LN, Lin MH, Chen LK. Associations between hemoglobin levels and sarcopenia and its components: Results from the I-Lan longitudinal study. Exp Gerontol. 2021 Jul 15;150:111379. doi: 10.1016/j.exger.2021.111379. Epub 2021 Apr 27. Erratum In: Exp Gerontol. 2022 Nov;169:111977. — View Citation

Warming 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. — View Citation

* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	The quality of life (QoL)	EQ-5D which measures health-related QoL through physical, psychological and social dimensions.	Change from Baseline the quality of life at 12 weeks
Secondary	Subjective health-status level	SF-36 questionnaire which measures the subjective health-status level.	Change from Baseline the health status level at 12 weeks
Secondary	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.	Change from Baseline MMSE at 12 weeks
Secondary	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.	Change from Baseline MoCA at 12 weeks
Secondary	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.	Change from Baseline Geriatric Depression Scale (GDS) at 12 weeks
Secondary	Nutritional profile measurements - Mediterranean Diet Adherence Screener index	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
Secondary	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.	Change from Baseline frailty degree at 12 weeks
Secondary	Body composition - Bioimpedance	The body composition will be evaluated by means of bioimpedance.	Change from Baseline Bioimpedance composition at 12 weeks
Secondary	Body composition - body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2	Change from Baseline body mass index (BMI) at 12 weeks
Secondary	Body composition - height	Height measure in meter	Change from Baseline height at 12 weeks
Secondary	Body composition - weight	Weight measure in kilograms	Change from Baseline weight at 12 weeks
Secondary	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).	Change from Baseline Musculoskeletal ultrasound architecture at 12 weeks
Secondary	Depressive Symptoms	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