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

Age-related Cognitive Decline Clinical Trial

Official title:

Effectiveness Of Computer-Based Cognitive Training Combined With Aerobic Training in Age-Related Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06226103
• Other study ID #: REC-45/06/919
• Status: Completed
• Phase: N/A
• Start date: January 7, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: January 2024
• Source: University of Jazan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• 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.
• 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

Locations

Country	Name	City	State
Saudi Arabia	Jazan University	Jazan

Sponsors (1)

Lead Sponsor	Collaborator
University of Jazan

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment test	A commonly used test to assess different cognitive domains, including short-term memory recall, visuospatial abilities, executive functions, attention, concentration, and working memory. MoCA scores range between 0 and 30 where the highest score is considered to be normal.	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)
Primary	Barthel Index	This index was used to measure an individual's capacity to perform ten activities of daily living, reflecting their functional independence. Total possible scores range from 0 - 20, with lower scores indicating increased disability.	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)
Primary	Short form survey-12	A generic measure utilized to assess the health-related quality of life, covering both physical and mental health dimensions. The summary scores range from a minimum of 0 to a maximum of 100. Higher the SF-12 scores, indicates the higher (better) quality of life.	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)