NCT03823183: VIBAL

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

Status unknown NA Last updated 1 February 2019

What this trial tests

NA trial testing Cognitive training in Executive Functions in 120 participants. Status unknown.

Timeline

1 October 2018

Primary endpoint
31 December 2019

31 December 2020

Quick facts

Lead sponsor	Universidad Nacional de Educación a Distancia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	basic science
Enrollment	120
Start date	1 October 2018
Primary completion	31 December 2019
Estimated completion	31 December 2020
Sites	1 location across Spain

Drugs / interventions tested

• Cognitive training
• Physical training
• Cognitive control
• Physical control

Conditions studied

• Executive Functions — all drugs for Executive Functions →
• Memory Functions — all drugs for Memory Functions →

Sponsor

Universidad Nacional de Educación a Distancia

Who can join

Adults 60 to 80, any sex, with Executive Functions or Memory Functions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of multidomain versus single-domain training on executive control and memory in older adults: study protocol for a randomized controlled trial.
   Ballesteros S, Rieker JA, Mayas J, Prieto A, et al · · 2020 · cited 5× · PMID 32410715 · DOI 10.1186/s13063-020-04293-3
2. RESILIENT AGING ROUNDTABLE: AN EVALUATION OF A BRIEF COMMUNITY PSYCHOEDUCATION DISCUSSION GROUP
   June A, Marty M. · · 2019
3. MEANING IN LIFE AMONG THE OLD-OLD
   Ermoshkina P, Kahana E, Kahana B. · · 2019
4. IS COMBINED TRAINING MORE EFFECTIVE THAN SINGLE-DOMAIN TRAINING: A RANDOMIZED CONTROLLED TRIAL WITH OLDER ADULTS
   Ballesteros S, Rieker J, Reales j, Mayas j, et al · · 2019
5. WHICH CAME FIRST, WELL-BEING OR PHYSICAL HEALTH? A LONGITUDINAL INVESTIGATION IN MID- TO LATE LIFE
   Raldiris T, Dzierzewski J. · · 2019
6. Program Abstracts from the GSA 2019 Annual Scientific Meeting “Strength in Age—Harnessing the Power of Networks”
   · 2019