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Clinical Trials/NCT06226103
NCT06226103
Completed
N/A

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

University of Jazan1 site in 1 country60 target enrollmentJanuary 15, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Age-related Cognitive Decline
Sponsor
University of Jazan
Enrollment
60
Locations
1
Primary Endpoint
Montreal Cognitive Assessment test
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
February 12, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Jazan
Responsible Party
Principal Investigator
Principal Investigator

Dr. Mohammad Abu Shaphe

Associate Professor

University of Jazan

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
  • 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

Outcomes

Primary Outcomes

Montreal Cognitive Assessment test

Time Frame: 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)

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.

Barthel Index

Time Frame: 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)

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.

Short form survey-12

Time Frame: 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)

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.

Study Sites (1)

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