Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults

NCT ID: NCT06434857

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2026-02-20

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.

Conditions

Cognitive Impairment; Aging Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Strength Training Group

The main part of the strength training program will have the following exercises: wall push-ups, arm raises, elbow push-ups and extensions, weighted pronosupination, hand press, knee and hip hinge squat, deadlifts, front and sagittal plan stride, and heel raises.

It will consist on different phases:

1. st phase: exercise adaptation: the correct execution of upper and lower limb exercises will be taught for one month.

2. nd phase: Resistance training: During the following seven months, strength exercises will be performed at slow and normal speed of the movement patterns learned in the training course, increasing load and volume according to each subject's individual progress.

Group Type: EXPERIMENTAL

Strength training in older adults with mild or non existent cognitive impairment

Intervention Type: PROCEDURE

Strength training program applied to strength training group

Multimodal Exercise Group

The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises. Playful activities or games are also included.

Exercises will be turned gradually more demanding along the duration of the program.

Group Type: ACTIVE_COMPARATOR

Multimodal excercise in older adults with mild or non existent cognitive impairment

Intervention Type: PROCEDURE

Multimodal exercise program applied to multimodal exercise group

Control Group

Participants in this group should continue with their usual dietary pattern and level of physical activity, without changing their lifestyle habits during the study period. They will not participate in the strength exercise program, nor will they perform systematic, programmed and supervised physical exercise in any other program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Strength training in older adults with mild or non existent cognitive impairment

Strength training program applied to strength training group

Intervention Type: PROCEDURE

Multimodal excercise in older adults with mild or non existent cognitive impairment

Multimodal exercise program applied to multimodal exercise group

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Arturo Dávila Marcos

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arturo Dávila Marcos

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Locations

University of Salamanca

Salamanca, , Spain

Countries

Spain

Central Contacts

Arturo Dávila Marcos

Role: CONTACT

turitodavila@usal.es

+34605998329

Facility Contacts

Arturo Dávila Marcos

Role: primary

turitodavila@usal.es

+34605998329

Other Identifiers

16069701

Identifier Type: -

Identifier Source: org_study_id