Multi-domain Versus Uni-Domain Training on Executive Control and Memory Functions of Older Adults

NCT ID: NCT03823183

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-12-31

Brief Summary

Age-related cognitive decline affects negatively daily living and quality of life of older adults. Previous research has shown a moderate impact of cognitive and physical training on the cognitive functioning of elders. This randomized controlled trial (RCT) examines the differential impact of multi-domain cognitive (video game training) and physical training (the physical exercise was Body-attack, a mixed of dance, aerobic, strength, and muscular resistance versus cognitive training and physical training separately, on executive control and memory functions of healthy older adults (N=120), in comparison with an active control group. Participants (between 60 and 80 years old) will be allocated randomly to one of the four experimental groups: 1) physical training-single domain: physical training and cognitive control activity; 2) cognitive training-single domain: cognitive training and physical control activity; 3) cognitive-physical multi-domain: physical training and cognitive training; 4) active control: physical control activity and cognitive control activity. Physical training will be group-based and include coordination, aerobic exercise and strength exercise. The physical control activity will include stretching and relaxation exercises. The cognitive training will consist of commercial brain training video games. Difficulty will be automatically adjusted to the performance level of the participant. The cognitive control activity will be cognitively non-demanding video games. Physical activities (experimental and control) will be trained for 40 min and cognitive activities (experimental and control) for 40 min consecutively during the same session. There will be 2 session/wk over 3 months. Executive functioning, memory functions and psychological wellbeing will be assessed using behavioral and electrophysiological measures at baseline, after study completion and at 3-month follow-up. The main goal was to investigate possible intervention-related transfer effects to untrained executive and memory functions. The goal is to find out whether multi-domain training improves more executive and memory functions that are often compromised in later years, but essential for everyday activities. We expect to find larger transfer effects in the multi-domain condition than in the uni-domain conditions, shorter ERP latencies of the P2 component, and enhanced N2 and P3b components after training.

Detailed Description

All participants complete one of the four combinations of cognitive training with video games and physical exercise. The cognitive component will be either a brain training video game program selected from Lumosity (cognitive intervention, CI) or video games not specifically designed to train attention and executive control (cognitive control, CC). The physical exercise component will be either Body-attack, a combination of dance, aerobic, strength, and muscular resistance (exercise intervention, EI) or its control condition composed of stretching, toning and relaxation (exercise control, EC).

Conditions

Executive Functions; Memory Functions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Multi-domain training

Group that receives cognitive training and physical training

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: BEHAVIORAL

Group-based cognitive training on iPads with commercially available video games (Lumosity) designed to enhance executive control, memory functions and processing speed. Difficulty will be automatically adjusted to the performance level of the participant. Participants will train for 40 min 2 days/wk over 3 months.

Physical training

Intervention Type: BEHAVIORAL

Group-based fitness program (senior-friendly adaption of BodyAttack) that combines aerobic, strength and coordination training to a music soundtrack. Participants will train for 40 min, 2 days/wk over 3 months.

Cognitive training

Group that receives cognitive training and physical control activity

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: BEHAVIORAL

Group-based cognitive training on iPads with commercially available video games (Lumosity) designed to enhance executive control, memory functions and processing speed. Difficulty will be automatically adjusted to the performance level of the participant. Participants will train for 40 min 2 days/wk over 3 months.

Physical control

Intervention Type: BEHAVIORAL

Group-based exercises program (based on relaxation and stretching) for 40 min, 2 days/wk over 3 months.

Physical activity

Group that receives control cognitive activity and physical training

Group Type: EXPERIMENTAL

Physical training

Intervention Type: BEHAVIORAL

Group-based fitness program (senior-friendly adaption of BodyAttack) that combines aerobic, strength and coordination training to a music soundtrack. Participants will train for 40 min, 2 days/wk over 3 months.

Cognitive control

Intervention Type: BEHAVIORAL

Group-based cognitive control activity consisting of playing on iPads non-cognitively demanding video games during 40 min 2 days/wk over 3 months and exercises based on relaxation and stretching for 40 min, 2 days/wk over 3 months.

Active control

Group that receives cognitive control activity and physical control activity

Group Type: ACTIVE_COMPARATOR

Cognitive control

Intervention Type: BEHAVIORAL

Group-based cognitive control activity consisting of playing on iPads non-cognitively demanding video games during 40 min 2 days/wk over 3 months and exercises based on relaxation and stretching for 40 min, 2 days/wk over 3 months.

Physical control

Intervention Type: BEHAVIORAL

Group-based exercises program (based on relaxation and stretching) for 40 min, 2 days/wk over 3 months.

Interventions

Cognitive training

Group-based cognitive training on iPads with commercially available video games (Lumosity) designed to enhance executive control, memory functions and processing speed. Difficulty will be automatically adjusted to the performance level of the participant. Participants will train for 40 min 2 days/wk over 3 months.

Intervention Type: BEHAVIORAL

Physical training

Group-based fitness program (senior-friendly adaption of BodyAttack) that combines aerobic, strength and coordination training to a music soundtrack. Participants will train for 40 min, 2 days/wk over 3 months.

Intervention Type: BEHAVIORAL

Cognitive control

Group-based cognitive control activity consisting of playing on iPads non-cognitively demanding video games during 40 min 2 days/wk over 3 months and exercises based on relaxation and stretching for 40 min, 2 days/wk over 3 months.

Intervention Type: BEHAVIORAL

Physical control

Group-based exercises program (based on relaxation and stretching) for 40 min, 2 days/wk over 3 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

No current intensive sports or physical activity practice. No current use of brain-training video games

Exclusion Criteria

Dementia. Mild Cognitive Impairment. A neurological or major psychiatric disorder. Significant heart illness. Lung disease.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Economy and Competitiveness (MINECO) - Government of Spain

UNKNOWN

Sponsor Role: collaborator

Universidad Nacional de Educación a Distancia

OTHER

Sponsor Role: lead

Responsible Party

Soledad Ballesteros

Investigator Official Title Ph.D. Emeritus Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soledad Ballesteros, PhD

Role: PRINCIPAL_INVESTIGATOR

UNED

Locations

Department of Basic Psychology II (UNED)

Madrid, , Spain

Countries

Spain

References

Ballesteros S, Rieker JA, Mayas J, Prieto A, Toril P, Jimenez MP, Reales JM. Effects of multidomain versus single-domain training on executive control and memory in older adults: study protocol for a randomized controlled trial. Trials. 2020 May 14;21(1):404. doi: 10.1186/s13063-020-04293-3.

Reference Type: DERIVED

PMID: 32410715 (View on PubMed)

Other Identifiers

PSI2016-80377-R

Identifier Type: -

Identifier Source: org_study_id