Age-related Cognitive DeclineNCT06226103
Effectiveness Of Computer-Based Cognitive Training in Age-Related Cognitive Decline
A study testing Aerobic Exercise and Computerized Cognitive Training and Conventional Exercises and Brain health lectures in people with Age-related Cognitive Decline, run by University of Jazan at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- Aerobic Exercise and Computerized Cognitive Training and Conventional Exercises and Brain health lectures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jan 2024to 12 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Age-related Cognitive Decline
- Being tested
- Aerobic Exercise and Computerized Cognitive Training, Conventional Exercises and Brain health lectures
- Keywords
- Cognition, Computer Based Cognitive Training, Aerobic Training, Exercises
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise and Computerized Cognitive TrainingOther
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 lecturesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group (Aerobic Exercise and Computerized Cognitive Training) | Experimental | 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). Receives: Other: Aerobic Exercise and Computerized Cognitive Training |
| Control Group | Active comparator | 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. Receives: Other: Conventional Exercises and Brain health lectures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start15 Jan 2024
- Primary completion25 Dec 2024
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Mohammad Abu Shaphe, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226103
- Sponsor's protocol ID
- REC-45/06/919
- Status last verified
- Jul 2025
- First submitted
- 5 Jan 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Computer-Based Cognitive Training Combined With Aerobic Training in Age-Related Cognitive Decline
- ClinicalTrials.gov ID
- NCT06226103
- Acronym / sponsor ID
- REC-45/06/919
- Conditions
- Age-related Cognitive Decline
- Keywords
- Cognition, Computer Based Cognitive Training, Aerobic Training, Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group (Aerobic Exercise and Computerized Cognitive Training) | Experimental | Other: Aerobic Exercise and Computerized Cognitive TrainingAerobic 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 | Active comparator | Other: Conventional Exercises and Brain health lecturesParticipants 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Major depression (scored > 9 in the Geriatric Depression Scale, GDS-15) [11]
- Schizophrenia
- Substance abuse
- parkinsonism
- conditions affecting gait (eg, severe osteoarthritis, previous stroke),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise and Computerized Cognitive TrainingAerobic 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. | Other | Interventional Group (Aerobic Exercise and Computerized Cognitive Training) |
| Conventional Exercises and Brain health lecturesParticipants 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 | Other | Control Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Computerized Cognitive Training and Conventional Exercises and Brain health lectures in people with Age-related Cognitive Decline, run by University of Jazan at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.