- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06226103
Effectiveness Of Computer-Based Cognitive Training in Age-Related Cognitive Decline
Effectiveness Of Computer-Based Cognitive Training Combined With Aerobic Training in Age-Related Cognitive Decline
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jazan, Saudi Arabia
- Jazan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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). |
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. |
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Active Comparator: 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.
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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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)
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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)
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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.
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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)
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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)
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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.
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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)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-45/06/919
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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