Clinical trial NCT06434857: Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults
Official title: Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults Undergoing an Occupational Therapy Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Aging Problems
Keywords: Aging
Cognitive impairment
Older adult
Strength training
Therapeutic exercise
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled clinical trial
Primary purpose: PREVENTION

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.

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 1:1:1 ratio. Randomization will be performed using the Epidat 4.2 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, Student's t-test will be used, and if they are non-parametric, the Wilcoxon test will be used. An alpha risk of 0.05 is set as the limit of statistical significance. The statistical program to be used will be SPSS, v.26.0.

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 14/2007 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.

Eligibility criteria: Inclusion Criteria:

* Subjects older than 65

Exclusion Criteria:

* Absolute contraindication for excersice
* Severe cognitive impairment or dementia
* Language barriers
* Pending litigation or legal claim

Primary outcomes:
measure: Cognitive functionality
timeFrame: 8 months
Secondary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: 6 months
measure: Athens insomnia scale
timeFrame: 6 months
measure: Body Mass Index (BMI)
timeFrame: 8 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: 8 months
measure: Gait speed
timeFrame: 8 months
measure: Timed Up and Go (TUG)
timeFrame: 8 months
measure: Lawton & Brody Scale
timeFrame: 8 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University of Salamanca
Study officials:
affiliation: University of Salamanca
name: Arturo Dávila Marcos
role: PRINCIPAL_INVESTIGATOR
References: