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

NCT03823183 | Unknown

• 1 other identifier: PSI2016-80377-R
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Executive Functions; Memory Functions

Keywords

Aging, geriatrics & gerontology; Video-game cognitive training; Dance; Physical exercise; Multi-domain training; Executive functions; Memory functions; Plasticity; Transfer; Follow-up intervention; Randomized controlled trial

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (7)

• Emotional and affective wellbeing assessed with Positive and Negative Affect Schedule (PANAS)

  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.

  Change from Baseline in LSI to 3 and 6 months

• Cardio-respiratory capacity assessed with the 6 Minutes Walk Test

  Change from Baseline in 6 Minutes Walk Test to 3 and 6 months

• Physical dimension assessed with The Short Physical Performance Battery (SPPB)

  Change from Baseline in SPPB to 3 and 6 months

• Demographic interview and medical history

  Baseline

Study Arms (4)

Multi-domain training

EXPERIMENTAL

Group that receives cognitive training and physical training

Behavioral: Cognitive training; Behavioral: Physical training

Cognitive training

EXPERIMENTAL

Group that receives cognitive training and physical control activity

Behavioral: Cognitive training; Behavioral: Physical control

Physical activity

EXPERIMENTAL

Group that receives control cognitive activity and physical training

Behavioral: Physical training; Behavioral: Cognitive control

Active control

ACTIVE COMPARATOR

Group that receives cognitive control activity and physical control activity

Behavioral: Cognitive control; Behavioral: Physical control

Interventions

Cognitive training 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.

Cognitive training; Multi-domain training

Physical training 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.

Multi-domain training; Physical activity

Cognitive control 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; Physical activity

Physical control BEHAVIORAL

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

Active control; Cognitive training

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Nacional de Educación a Distancia: lead
• Ministry of Economy and Competitiveness (MINECO) - Government of Spain: collaborator

Study Sites (1)

Department of Basic Psychology II (UNED)

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 32410715 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Cognitive Training; Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Soledad Ballesteros, PhD

  UNED

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Official Title Ph.D. Emeritus Professor of Psychology

Model Details: This study includes 4 intervention conditions: (1) Multi-modal Cognitive intervention + Physical intervention, (2) Cognitive intervention + Physical control, (3) Physical intervention + Cognitive control, and (4) Active Control group, Cognitive control + Physical control) x 3 (Time: Pretest, Post-test, 3-month follow-up) mixed factorial design, with "Type of training" as between-subject factors and "Time" as within-subject factor. The dependent variables will be behavioral and/or electrophysiological measures of executive functions (inhibition, shifting, working memory), memory functions (short term, episodic memory), and emotional well-being, quality of live and motivation.

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 30, 2019
• Study Start: October 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

ES (1)