Clinical trial NCT03823183: Multi-domain Versus Uni-Domain Training on Executive Control and Memory Functions of Older Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Ministry of Economy and Competitiveness (MINECO) - Government of Spain
First posted: 2019-01-30
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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).

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.

Primary outcomes:
measure: Executive functions assessed with Memory-based Task Switching
timeFrame: Change from Baseline in Memory-based Task Switching to 3 and 6 months
measure: Executive functions assessed with Memory-based Task Switching
timeFrame: Change from Baseline in Memory-based Task Switching to 3 and 6 months
measure: Attention assessed with Trail Making Test A+B
timeFrame: Change from Baseline in Trail Making Test to 3 and 6 months
measure: Inhibition assessed with Stroop Task
timeFrame: Change from Baseline in Stroop Task to 3 and 6 months
measure: Working memory assessed with the N-back Task
timeFrame: Change from Baseline in the N-Back Task to 3 and 6 months
measure: Immediate visual memory assessed with Visual Memory Face I (Weschler Memory Scale)
timeFrame: Change from Baseline in Face I to 3 and 6 months
measure: Differed visual memory assessed with Visual Memory Face II (Weschler Memory Scale)
timeFrame: Change from Baseline in Face II to 3 and 6 months
measure: Immediate verbal memory assessed with Pair-Words I (Weschler Memory Scale)
timeFrame: Change from Baseline in Pair-Words I to 3 and 6 months
measure: Differed verbal memory assessed with Pair-Words II (Weschler Memory Scale)
timeFrame: Change from Baseline in Pair-Words II to 3 and 6 months
Secondary outcomes:
measure: Emotional and affective wellbeing assessed with Positive and Negative Affect Schedule (PANAS)
timeFrame: Change from Baseline in PANAS to 3 and 6 months
measure: 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.
timeFrame: Change from Baseline in LSI to 3 and 6 months
measure: Cardio-respiratory capacity assessed with the 6 Minutes Walk Test
timeFrame: Change from Baseline in 6 Minutes Walk Test to 3 and 6 months
measure: Physical dimension assessed with The Short Physical Performance Battery (SPPB)
timeFrame: Change from Baseline in SPPB to 3 and 6 months
measure: Demographic interview and medical history
timeFrame: Baseline
measure: General cognitive state assessed with Mini Mental State Examination (MMSE)
timeFrame: Baseline
measure: General depression state assessed with Yesavage Abbreviate Questionnaire. (GDS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Department of Basic Psychology II (UNED)
Study officials:
affiliation: UNED
name: Soledad Ballesteros, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.