Effectiveness Of Computer-Based Cognitive Training in Age-Related Cognitive Decline

NCT ID: NCT06226103

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2025-02-12

Brief Summary

Background: Ageing is frequently accompanied by physiological changes that might result in a deterioration in physical and cognitive abilities, which frequently leads to institutionalization or the loss of autonomy. Mild cognitive impairment (MCI) is an intermediate state between normal cognitive aging and early dementia, the optimal period to intervene with preventive strategies and early treatments. Thus, the current study intends to investigate the effects of aerobic and computer-based cognitive training on age-related cognitive decline.

Methods: This is a single-blinded, randomized controlled trial. Elderly patients with mild cognitive impairment (n = 60) will be randomized to 2 arms and treated for 12 weeks: arm 1 (aerobic exercise and computerized cognitive training) and arm 2 (Placebo; will not receive any intervention). Outcome measure used were Montreal Cognitive Assessment (MOCA) test, Barthel Index (BI) and short form survey-12 (SF-12).

Statistical Analysis: To compare the baseline characteristics and outcome variables between the two groups, independent t-tests was employed. A two-way repeated measures ANOVA was utilized to determine the interaction effect of time (baseline, post-treatment, and follow-up) and group (intervention vs. control) on the outcome measures.

Conditions

Age-related Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Interventional Group (Aerobic Exercise and Computerized Cognitive Training)

Aerobic Exercise (AE) included walk briskly, increasing intensity and duration progressively. The first week they had to walk 30 min per day, 3 days per week, up to 9-10 on the Borg Rating of Perceived Exertion Scale (BRPES; Borg, 1982) perceived as light intensity; during the second week, the duration was increased to 45 min and the intensity 9-10 and frequency (3 days per week) were maintained; the following 10 weeks they maintained the duration (45 min) and frequency (3 days per week) and increased the intensity up to 12-14 on BRPES perceived as moderate-high effort.

Computerized Cognitive Training (CCT) included a multidomain computer-based cognitive training using the brainHQ software in sessions of 45 min, 3 days per week for 12 weeks. Cognitive tasks targeted attention, recognition, colour and shape, identification, calculation, visual perception, visual spatial processing, memory, and executive function).

Group Type: EXPERIMENTAL

Aerobic Exercise and Computerized Cognitive Training

Intervention Type: OTHER

Aerobic Exercise (AE) included walk briskly, increasing intensity and duration progressively. The first week they had to walk 30 min per day, 3 days per week, up to 9-10 on the Borg Rating of Perceived Exertion Scale (BRPES; Borg, 1982) perceived as light intensity; during the second week, the duration was increased to 45 min and the intensity 9-10 and frequency (3 days per week) were maintained; the following 10 weeks they maintained the duration (45 min) and frequency (3 days per week) and increased the intensity up to 12-14 on BRPES perceived as moderate-high effort.

Computerized Cognitive Training (CCT) included a multidomain computer-based cognitive training using the brainHQ software in sessions of 45 min, 3 days per week for 12 weeks. Cognitive tasks targeted attention, recognition, colour and shape, identification, calculation, visual perception, visual spatial processing, memory, and executive function.

Control Group

Participants were exposed to balancing, coordination, stretching, and core exercises. Additionally, they attended brain health lectures to provide a comparative non-interactive cognitive engagement. Both the exercises and lectures were scheduled similar to the intervention group over 12 weeks.

Group Type: ACTIVE_COMPARATOR

Conventional Exercises and Brain health lectures

Intervention Type: OTHER

Participants were exposed to balancing, coordination, stretching, and core exercises. Additionally, they attended brain health lectures to provide a comparative non-interactive cognitive engagement. Both the exercises and lectures were scheduled similar to the intervention group over 12 weeks

Interventions

Aerobic Exercise and Computerized Cognitive Training

Aerobic Exercise (AE) included walk briskly, increasing intensity and duration progressively. The first week they had to walk 30 min per day, 3 days per week, up to 9-10 on the Borg Rating of Perceived Exertion Scale (BRPES; Borg, 1982) perceived as light intensity; during the second week, the duration was increased to 45 min and the intensity 9-10 and frequency (3 days per week) were maintained; the following 10 weeks they maintained the duration (45 min) and frequency (3 days per week) and increased the intensity up to 12-14 on BRPES perceived as moderate-high effort.

Computerized Cognitive Training (CCT) included a multidomain computer-based cognitive training using the brainHQ software in sessions of 45 min, 3 days per week for 12 weeks. Cognitive tasks targeted attention, recognition, colour and shape, identification, calculation, visual perception, visual spatial processing, memory, and executive function.

Intervention Type: OTHER

Conventional Exercises and Brain health lectures

Participants were exposed to balancing, coordination, stretching, and core exercises. Additionally, they attended brain health lectures to provide a comparative non-interactive cognitive engagement. Both the exercises and lectures were scheduled similar to the intervention group over 12 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Who fulfilled MCI criteria [10]: (1) subjective cognitive concerns; (2) objective cognitive impairment in memory, executive function, attention, and/or language; (3) preserved activities of daily living; and (4) absence of dementia
• Literate
• Had adequate visual, auditory, and fine motor skills.

Exclusion Criteria

• Major depression (scored > 9 in the Geriatric Depression Scale, GDS-15) [11]
• Schizophrenia
• Substance abuse
• parkinsonism
• conditions affecting gait (eg, severe osteoarthritis, previous stroke),
• participated in any cognitive training program during last 6 months > 2 h/week
• ACSM contraindications to exercise or other factors that make exercise impossible or unsafe
• cognitive enhancers, or anticholinergics

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jazan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Mohammad Abu Shaphe

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jazan University

Jizan, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

REC-45/06/919

Identifier Type: -

Identifier Source: org_study_id