Frailty Syndrome Clinical Trial
Official title:
Application of a Nutritional Counseling Program on the Frailty of Older Adults in the Mexican Population
In the present study, the COM-B model is intended to be used as a central axis in the planning of the nutritional counseling intervention, since it proposes that behavioral modification is conditioned by the capacity, opportunity and motivation of the person, 3 basic components that can be addressed with nutritional education and goal-setting strategies, self-monitoring and social support. The intervention will consist of applying nutritional counseling in older adults with frailty syndrome to measure the effect on indicators of this syndrome such as nutritional status, handgrip strength, protein consumption and physical activity.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | November 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | Inclusion Criteria: - Men and women over 60 years of age - That they have a normal cognitive function (more than 24 points in the minimental test) - That they attend weekly the Metropolitan Center for the Elderly (DIF Zapopan) - Who suffer from frailty or pre-frailty (from 1 to 5 points on the frailty scale) Exclusion Criteria: - Severe dysphagia - Consumption of food supplements (protein powder or vitamins) - Senile dementia, cognitive impairment or Alzheimer's - People who are following a diet or physical activity plan prescribed by a professional |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Instituto Tecnologico y de Estudios Superiores de Monterey |
Andersson J, Hulander E, Rothenberg E, Iversen PO. Effect on Body Weight, Quality of Life and Appetite Following Individualized, Nutritional Counselling to Home-Living Elderly after Rehabilitation - An Open Randomized Trial. J Nutr Health Aging. 2017;21(7):811-818. doi: 10.1007/s12603-016-0825-8. — View Citation
Faber MJ, Bosscher RJ, Chin A Paw MJ, van Wieringen PC. Effects of exercise programs on falls and mobility in frail and pre-frail older adults: A multicenter randomized controlled trial. Arch Phys Med Rehabil. 2006 Jul;87(7):885-96. — View Citation
Fernández-Barrés S, García-Barco M, Basora J, Martínez T, Pedret R, Arija V; Project ATDOM-NUT group. The efficacy of a nutrition education intervention to prevent risk of malnutrition for dependent elderly patients receiving Home Care: A randomized controlled trial. Int J Nurs Stud. 2017 May;70:131-141. doi: 10.1016/j.ijnurstu.2017.02.020. Epub 2017 Feb 23. — View Citation
Gardner B, Jovicic A, Belk C, Kharicha K, Iliffe S, Manthorpe J, Goodman C, Drennan VM, Walters K. Specifying the content of home-based health behaviour change interventions for older people with frailty or at risk of frailty: an exploratory systematic review. BMJ Open. 2017 Feb 9;7(2):e014127. doi: 10.1136/bmjopen-2016-014127. Review. — View Citation
Nykänen I, Rissanen TH, Sulkava R, Hartikainen S. Effects of individual dietary counseling as part of a comprehensive geriatric assessment (CGA) on nutritional status: a population-based intervention study. J Nutr Health Aging. 2014 Jan;18(1):54-8. doi: 10.1007/s12603-013-0342-y. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frailty syndrome | Geriatric syndrome characterized by a decreased ability of the body to respond to external stressors, causing in the individual: risk of falls, functional decline, disability, dependency, institutionalization and even death.
For its evaluation, the frailty scale valid in Mexicans proposed by Díaz de León González in 2016 will be used. It considers 5 questions and classifies those with a score between 3 to 5 points as frail, pre-fragile between 1 and 2 and non-fragile with a score of zero. Questions: Do you feel tired most of the time? Can you walk up one flight of stairs without breaks or help? Are you able to walk 100 m without pausing and without assistance? Have more than 5 symptoms. Arthritis, diabetes, angina/heart attack, hypertension, stroke, asthma, chronic bronchitis, emphysema, osteoporosis, colorectal cancer, skin cancer, depression/anxiety, dementia, leg ulcers. Weightloss: > 5% in the last year |
6 months | |
Secondary | Protein intake | Intake of grams of protein per day from animal or vegetable sources. It will be evaluated through a 24-hour recall. | 6 months | |
Secondary | Malnutrition | Malnutrition is a lack of calories or one or more essential nutrients. It will be measured through the Mini Nutritional Assessment long form (MNA-LF), a screening tool to help identify elderly patients who are malnourished or at risk of malnutrition.
The tool consists of a 18-item in the long form scale. |
6 months | |
Secondary | Handgrip strength | It is the maximum isometric strength of the hand and forearm muscles.. It will be evaluated through the pressure force of the participant's dominant hand estimated through a dynamometer and whose cut-off points refer to a decrease in force when it is below 30 kg in men or 20 kg in women. | 6 months | |
Secondary | sedentary activities | Those activities that people do sitting or reclining, while we are awake, and that use very little energy.
These will be evaluated through self-report of sedentary activities Adapted from the ASAQ Questionnaire (Adolescent Sedentary Activity Questionnaire) |
6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04888884 -
Loss of Independence - a Rapid Alternative to Frailty Screening in a Swedish ED Setting
|
||
Active, not recruiting |
NCT05961319 -
Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
|
||
Recruiting |
NCT04518423 -
Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People
|
||
Active, not recruiting |
NCT04830865 -
Adaptation and Validation of Frailty Scales in Intensive Care Units in Spain
|
||
Not yet recruiting |
NCT05962203 -
SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania
|
N/A | |
Recruiting |
NCT04914403 -
Mesenchymal Stem Cells for The Treatment of Frailty Syndrome
|
Phase 1 | |
Recruiting |
NCT03963050 -
Successful Aging and Frailty
|
N/A | |
Recruiting |
NCT04173715 -
Movement and Behaviours Measurement Study
|
||
Active, not recruiting |
NCT06079762 -
AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program
|
N/A | |
Recruiting |
NCT04954690 -
Structured Program of Exercise for Recipients of Kidney Transplantation
|
N/A | |
Recruiting |
NCT04360109 -
Study of the Association Between Presbycusis With the Incidence of Frailty
|
||
Recruiting |
NCT04592146 -
Maintaining and imPrOving the intrinSIc capaciTy Involving Primary Care and caregiVErs
|
N/A | |
Completed |
NCT05668221 -
Multidisciplinary Prehabilitation to Improve Frailty and Functional Capacity in High-risk Elective Surgical Patients: a Retrospective Pilot Study
|
||
Completed |
NCT03949439 -
Pre-frailty and Rehospitalization in Cardiac Surgery
|
||
Recruiting |
NCT04746768 -
Frailty Syndrome of Post-cancer Treatment Eldery Patients
|
N/A | |
Withdrawn |
NCT04321603 -
Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65
|
N/A | |
Recruiting |
NCT05435534 -
Effect of a Multicomponent Intervention on Functional Capacity After Hip Fracture
|
N/A | |
Recruiting |
NCT06465602 -
Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls
|
Phase 2 | |
Withdrawn |
NCT04241159 -
Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults
|
Early Phase 1 | |
Enrolling by invitation |
NCT02685839 -
Development of an Intelligent POWER Rehabilitation Cluster Machine and Its Clinical Testing and Assessment
|
N/A |