Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults

NCT06434857 | Not Yet Recruiting

• 1 other identifier: 16069701
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Aging Problems

Keywords

Aging; Cognitive impairment; Older adult; Strength training; Therapeutic exercise

Outcome Measures

Primary Outcomes (1)

• Cognitive functionality

  Cognitive functionality will be measured with the Montreal Scales Assessment (MOCA). Maximum score is 30, considering a punctuation ≥ 26 is considered normal.

  8 months

Secondary Outcomes (7)

• Pittsburgh sleep quality index

  6 months

• Athens insomnia scale

  6 months

• Body Mass Index (BMI)

  8 months

• Short Physical Performance Battery (SPPB)

  8 months

• Gait speed

  8 months

Study Arms (3)

Strength Training Group

EXPERIMENTAL

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.

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

Multimodal Exercise Group

ACTIVE COMPARATOR

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.

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

Control Group

NO INTERVENTION

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.

Interventions

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

Strength training program applied to strength training group

Strength Training Group

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

Multimodal exercise program applied to multimodal exercise group

Multimodal Exercise Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects older than 65

You may not qualify if:

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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Resistance Training; Aging

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Growth and Development; Physiological Phenomena

Study Officials

• Arturo Dávila Marcos

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arturo Dávila Marcos

CONTACT

+34605998329; turitodavila@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Randomized, controlled clinical trial

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: September 15, 2024
• Primary Completion: January 30, 2025
• Study Completion: February 20, 2026
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)