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

Protocol for a Randomized Controlled Trial With Active Control on the Effects of Combined Physical and Cognitive Training Versus Cognitive and Physical Training Separately on Executive Control and Memory Functions of Older Adults

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.

Study Overview

• Status: Unknown
• Conditions: Memory Functions; Executive Functions
• Intervention / Treatment: Behavioral: Cognitive training; Behavioral: Physical training; Behavioral: Physical control; Behavioral: Cognitive control

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).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Department of Basic Psychology II (UNED)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-domain training; Group that receives cognitive training and physical training	Behavioral: 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.; 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.
Experimental: Cognitive training; Group that receives cognitive training and physical control activity	Behavioral: 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.; Behavioral: Physical control; Group-based exercises program (based on relaxation and stretching) for 40 min, 2 days/wk over 3 months.
Experimental: Physical activity; Group that receives control cognitive activity and physical training	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.; 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.
Active Comparator: Active control; Group that receives cognitive control activity and physical control activity	Behavioral: Physical control; Group-based exercises program (based on relaxation and stretching) for 40 min, 2 days/wk over 3 months.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive functions assessed with Memory-based Task Switching	Reaction time (RT) of correct responses in Memory-based Task Switching	Change from Baseline in Memory-based Task Switching to 3 and 6 months
Executive functions assessed with Memory-based Task Switching	Performance in the Memory-base Task Switching: Neurophysiological parameter-Event-related potentials (ERPs) in the Memory-Based Task Switching	Change from Baseline in Memory-based Task Switching to 3 and 6 months
Attention assessed with Trail Making Test A+B	Performance in Trail Making Test A+B score	Change from Baseline in Trail Making Test to 3 and 6 months
Inhibition assessed with Stroop Task	Reaction time (RT) of correct responses in the Stroop Task	Change from Baseline in Stroop Task to 3 and 6 months
Working memory assessed with the N-back Task	Hits-False Alarms in the N-back Task	Change from Baseline in the N-Back Task to 3 and 6 months
Immediate visual memory assessed with Visual Memory Face I (Weschler Memory Scale)	Units on the Scale: scale range (minimum score = 0 and maximum score = 48).	Change from Baseline in Face I to 3 and 6 months
Differed visual memory assessed with Visual Memory Face II (Weschler Memory Scale)	Units on the Scale: scale range (minimum score = 0 and maximum score = 48). With data from Visual Memory Face I (inmediate recognition) and Visual Memory Face II (differed recognition) we compute the percentage of memory retention = Visual Memory Face II / Visual Memory Face I X 100	Change from Baseline in Face II to 3 and 6 months
Immediate verbal memory assessed with Pair-Words I (Weschler Memory Scale)	Units on the Scale: scale range for Recall (minimum score = 0 and maximum score = 32).	Change from Baseline in Pair-Words I to 3 and 6 months
Differed verbal memory assessed with Pair-Words II (Weschler Memory Scale)	Units on the Scale: scale range for Recall (minimum score = 0 and maximum score = 8). scale range for Recognition (minimum score =0 and maximum score = 24) Recall. With data from Pair-Words I (inmediate recognition) and Pair-Words II (differed recognition) we compute the percentage of memory retention = Pair-Words II / Pair-Word I X 100	Change from Baseline in Pair-Words II to 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional and affective wellbeing assessed with Positive and Negative Affect Schedule (PANAS)	Units on the Scale: 20 items Each item is evaluated between 0 (nothing) and 5 (many). Positive emotions are assessed with items: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19. Negative emotions are assessed with items: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20.	Change from Baseline in PANAS to 3 and 6 months
Emotional and affective wellbeing assessed with The Life Satisfaction Index (LSI): 20 items Each item is assessed using two-point agree/disagree score rated items 0 for a response indicating dissatisfaction and 1 for satisfaction.	Units on the Scale: 20 items A two-point agree/disagree score rated items 0 for a response indicating dissatisfaction and 1 for satisfaction.	Change from Baseline in LSI to 3 and 6 months
Cardio-respiratory capacity assessed with the 6 Minutes Walk Test	Physiological parameter	Change from Baseline in 6 Minutes Walk Test to 3 and 6 months
Physical dimension assessed with The Short Physical Performance Battery (SPPB)	Units on the Scale	Change from Baseline in SPPB to 3 and 6 months
Demographic interview and medical history	Respond to questions related to demographics and medical history	Baseline
General cognitive state assessed with Mini Mental State Examination (MMSE)	Units on the test: scale range (minimum score = 0 and maximum score = 30). Values between 27 and 30 points are considered as "appropriate cognitive state". Values between 24 and 26 points are considered as "possible mild cognitive impairment" Values between 0 and 23 points are considered as "possible dementia". This test is a screening test and it is not adequate to diagnose. In this protocol participants with scores under 27 will be excluded from the study.	Baseline
General depression state assessed with Yesavage Abbreviate Questionnaire. (GDS)	Units on the test: scale range (minimum score = 0 and maximum score = 15). Values between 0 and 5 points are considered as "no depression". Values between 5 and 10 points are considered as "mild depression" Values between 10 and 15 points are considered as "severe depression". This test is a screening test and it is not adequate to diagnose. In this protocol participants with scores greater than 5 will be excluded from the study.	Baseline

Collaborators and Investigators

• Sponsor: Universidad Nacional de Educación a Distancia
• Collaborators: Ministry of Economy and Competitiveness (MINECO) - Government of Spain
• Investigators: Principal Investigator: Soledad Ballesteros, PhD, UNED

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 27, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Transfer; Physical exercise; Plasticity; Executive functions; Dance; Aging, geriatrics & gerontology; Video-game cognitive training; Multi-domain training; Memory functions; Follow-up intervention
• Other Study ID Numbers: PSI2016-80377-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No