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
Overview
- Phase
- Not Applicable
- Sponsor
- Universidad Nacional de Educación a Distancia
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Immediate visual memory assessed with Visual Memory Face I (Weschler Memory Scale)
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Immediate visual memory assessed with Visual Memory Face I (Weschler Memory Scale)
Time Frame: Change from Baseline in Face I to 3 and 6 months
Units on the Scale: scale range (minimum score = 0 and maximum score = 48).
Executive functions assessed with Memory-based Task Switching
Time Frame: Change from Baseline in Memory-based Task Switching to 3 and 6 months
Performance in the Memory-base Task Switching: Neurophysiological parameter-Event-related potentials (ERPs) in the Memory-Based Task Switching
Differed visual memory assessed with Visual Memory Face II (Weschler Memory Scale)
Time Frame: Change from Baseline in Face II to 3 and 6 months
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
Differed verbal memory assessed with Pair-Words II (Weschler Memory Scale)
Time Frame: Change from Baseline in Pair-Words II to 3 and 6 months
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
Attention assessed with Trail Making Test A+B
Time Frame: Change from Baseline in Trail Making Test to 3 and 6 months
Performance in Trail Making Test A+B score
Inhibition assessed with Stroop Task
Time Frame: Change from Baseline in Stroop Task to 3 and 6 months
Reaction time (RT) of correct responses in the Stroop Task
Working memory assessed with the N-back Task
Time Frame: Change from Baseline in the N-Back Task to 3 and 6 months
Hits-False Alarms in the N-back Task
Immediate verbal memory assessed with Pair-Words I (Weschler Memory Scale)
Time Frame: Change from Baseline in Pair-Words I to 3 and 6 months
Units on the Scale: scale range for Recall (minimum score = 0 and maximum score = 32).
Secondary Outcomes
- Physical dimension assessed with The Short Physical Performance Battery (SPPB)(Change from Baseline in SPPB to 3 and 6 months)
- Emotional and affective wellbeing assessed with Positive and Negative Affect Schedule (PANAS)(Change from Baseline in PANAS to 3 and 6 months)
- Demographic interview and medical history(Baseline)
- General depression state assessed with Yesavage Abbreviate Questionnaire. (GDS)(Baseline)
- 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)
- General cognitive state assessed with Mini Mental State Examination (MMSE)(Baseline)
Investigators
Soledad Ballesteros
Investigator Official Title Ph.D. Emeritus Professor of Psychology
Universidad Nacional de Educación a Distancia