Clinical trial NCT06226103: Effectiveness Of Computer-Based Cognitive Training in Age-Related Cognitive Decline
Official title: Effectiveness Of Computer-Based Cognitive Training Combined With Aerobic Training in Age-Related Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cognitive Decline
Keywords: Cognition
Computer Based Cognitive Training
Aerobic Training
Exercises
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2024-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Montreal Cognitive Assessment test
timeFrame: at the baseline (day 0), at the end of the treatment (after 12 weeks) as well as after 4 weeks of follow up (after 16 weeks)
measure: Barthel Index
timeFrame: at the baseline (day 0), at the end of the treatment (after 12 weeks) as well as after 4 weeks of follow up (after 16 weeks)
measure: Short form survey-12
timeFrame: at the baseline (day 0), at the end of the treatment (after 12 weeks) as well as after 4 weeks of follow up (after 16 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Jazan University
Study officials:
References: