Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults
Sponsor:
University of Salamanca
Organization:
University of Salamanca
Study Overview
Official Title:
Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults Undergoing an Occupational Therapy Program
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized parallel double-blind clinical trial The main objective is to compare the efficacy of strength training multimodal exercise with non-specific exercises and a control group on cognitive functionality and physical composition in subjects over 65 years of age with mild or non existent cognitive impairment currently receiving occupational therapy
The intervention in both groups will be carried out for 30 weeks with three weekly sessions Two evaluations will be performed one pre-intervention and one post-intervention Cognitive Functionality Montreal Cognitive Assessment MOCA and Lawton and Brody Scale Sleep quality Athens insomnia scale and Pittsburgh sleep quality index physical functionality Timed up and go TUG chair stand test and hand grip test and Short Physical Performance Battery SPPB body composition Body fat skeletal muscle index SMI appendicular skeletal muscle ASM waist circumference waist hip ratio body weight body mass index BMI will be evaluated
The intervention in both groups will be carried out for 30 weeks with three weekly sessions Two evaluations will be performed one pre-intervention and one post-intervention Cognitive Functionality Montreal Cognitive Assessment MOCA and Lawton and Brody Scale Sleep quality Athens insomnia scale and Pittsburgh sleep quality index physical functionality Timed up and go TUG chair stand test and hand grip test and Short Physical Performance Battery SPPB body composition Body fat skeletal muscle index SMI appendicular skeletal muscle ASM waist circumference waist hip ratio body weight body mass index BMI will be evaluated
Detailed Description:
Design Randomized controlled clinical trial with three parallel groups in which subjects over 65 years of age will be recruited Study participants will be assigned to one of the three intervention groups The study will have a duration of 8 months There will be 2 evaluation visits an initial one and a final one after 8 months During 8 months there will be 3 weekly sessions lasting 50 minutes
Scope The study will be carried out in the Salamanca Health Area in collaboration with the Research Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council
Interventions 1 Multimodal Exercise Group GEM 2 Strength Exercise Group GES 3 No Exercise Control Group CG The GEM and GES sessions follow the same structural pattern They will be structured according to the recommendations of the American College of Sports Medicine ACSM In the main part of the GES only strength exercises will be performed
Study population 90 subjects over 65 years of age from the city of Salamanca will be recruited distributed in 3 groups at a 111 ratio Randomization will be performed using the Epidat 42 program The sample size was calculated using GRANMO Version 7 12 April 2012
The main study variables are Cognitive functionality Montreal Cognitive Assessment MOCA and Lawton and Brody Scale Sleep quality Athens insomnia scale and Pittsburgh sleep quality index Physical Functionality Timed Up Go test TUG chair stand test and hand grip test and Short Physical Performance Battery SPPB body composition Body fat skeletal muscle index SMI appendicular skeletal muscle ASM waist circumference waist hip ratio body weight body mass index BMI SARC-F Questionnaire RM estimated by force-velocity profile and Gait speed
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables Statistical analysis The effect of the intervention on the study variables if the variables are parametric Students t-test will be used and if they are non-parametric the Wilcoxon test will be used An alpha risk of 005 is set as the limit of statistical significance The statistical program to be used will be SPSS v260
The study will be carried out with the authorization of the Ethics Committee on Drug Research CEIm of the Salamanca Health Area and with the prior informed consent of the study subjects The participants will be informed of the objectives of the project and of the risks and benefits of the examinations and interventions to be performed The study has been designed and subsequently assessed in accordance with Law 142007 on Biomedical Research the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects as well as the other ethical principles and legal regulations applicable according to the characteristics of the study
Scope The study will be carried out in the Salamanca Health Area in collaboration with the Research Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council
Interventions 1 Multimodal Exercise Group GEM 2 Strength Exercise Group GES 3 No Exercise Control Group CG The GEM and GES sessions follow the same structural pattern They will be structured according to the recommendations of the American College of Sports Medicine ACSM In the main part of the GES only strength exercises will be performed
Study population 90 subjects over 65 years of age from the city of Salamanca will be recruited distributed in 3 groups at a 111 ratio Randomization will be performed using the Epidat 42 program The sample size was calculated using GRANMO Version 7 12 April 2012
The main study variables are Cognitive functionality Montreal Cognitive Assessment MOCA and Lawton and Brody Scale Sleep quality Athens insomnia scale and Pittsburgh sleep quality index Physical Functionality Timed Up Go test TUG chair stand test and hand grip test and Short Physical Performance Battery SPPB body composition Body fat skeletal muscle index SMI appendicular skeletal muscle ASM waist circumference waist hip ratio body weight body mass index BMI SARC-F Questionnaire RM estimated by force-velocity profile and Gait speed
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables Statistical analysis The effect of the intervention on the study variables if the variables are parametric Students t-test will be used and if they are non-parametric the Wilcoxon test will be used An alpha risk of 005 is set as the limit of statistical significance The statistical program to be used will be SPSS v260
The study will be carried out with the authorization of the Ethics Committee on Drug Research CEIm of the Salamanca Health Area and with the prior informed consent of the study subjects The participants will be informed of the objectives of the project and of the risks and benefits of the examinations and interventions to be performed The study has been designed and subsequently assessed in accordance with Law 142007 on Biomedical Research the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects as well as the other ethical principles and legal regulations applicable according to the characteristics of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None