Mild Cognitive ImpairmentNCT06867016
Effects of Bidomain Cognitive and Aerobic Training on Cognitive Functioning in Mild Cognitive Impairment.
A study testing Combined Cognitive & Aerobics Training and Cognitive Training in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study aims to assess the effects of Bidomain cognitive and aerobic training on both cognitive functioning and quality of life in individuals with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Combined Cognitive & Aerobics Training and Cognitive Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2025to 28 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults 60 years \& above
- With normal vision and color perception
- Independent Individual capable of carrying out daily tasks
- Individuals scoring 21-25 on the Mini-Mental State Examination (MMSE)
Who cannot join
- Medication affecting the exercise capacity of individual
- Regular participation in aerobic training for the last six months
- Cardiovascular or other diseases that do not allow physical activity
- A diagnosed severe psychiatric disease (e.g., depression)
- Patients with cognitive impairment or other neurological impairments due to AD or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to assess the effects of Bidomain cognitive and aerobic training on both cognitive functioning and quality of life in individuals with mild cognitive impairment.
Read the detailed description
The proposed study addresses a notable gap in the literature regarding the comparison between combined cognitive-aerobic training and cognitive training alone in improving cognitive function for patients with mild cognitive impairment (MCI). While previous studies have demonstrated the positive effects of both training methods on cognitive function independently, there is currently no research directly comparing their effectiveness when used together. The study aims to provide evidence on which treatment regime-combined cognitive-aerobic training or cognitive training alone-offers better outcomes for MCI patients. Aerobic training is known to enhance brain structure and function by strengthening neuronal connections, largely due to increased levels of brain-derived neurotrophic factor (BDNF) and enhanced vascularization, which stimulates hippocampal growth. On the other hand, cognitive training improves global cerebral functional connectivity, particularly activating the prefrontal cortex, which leads to better cognitive performance. Combining these training modalities may yield greater benefits than focusing on just one, offering a cost-effective, accessible approach that could significantly improve the quality of life and daily functioning for individuals with MCI.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Combined Cognitive & Aerobics Training, Cognitive Training
- Keywords
- Cognition, Old age, mild cognitive impairment, aerobic, cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Cognitive & Aerobics TrainingOther
The ACT combined training will consist of simultaneous aerobic exercise and cognitive training in a dual-task format, conducted twice a week for 8 weeks. The aerobic training (AT) will consist of twice-weekly sessions that include yoga, brisk walking, pedaling exercises, and step aerobics, alongside cognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises. Each session will last approximately 20 minutes, and assessments will be performed at baseline, 4th week, and 8th week.
Cognitive TrainingOther
Cognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises. Each session will last approximately 20 minutes, and assessments will be performed at baseline, the 4th week, and the 8th week.
| Study group | Role | What they receive |
|---|---|---|
| Combined Cognitive & Aerobic Training Group | Experimental | The ACT combined training will consist of simultaneous aerobic exercise and cognitive training in a dual-task format. Receives: Other: Combined Cognitive & Aerobics Training |
| Cognitive Training Group | Active comparator | Cognitive training group include cognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises. Receives: Other: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-mental state examination (MMSE)
The Mini-Mental State Examination (MMSE) is a widely used screening test for cognitive deficits, with scores ranging from 0 to 30. A score of 24 or below indicates potential cognitive impairment, particularly for patients aged 65 and older. The MMSE evaluates verbal abilities, where scores of 30-27 are considered normal, while lower scores indicate mild (26-21 points), moderate (20-10 points), or severe (9-0 points) dementia.
Measured: 8 weeks
Short Cognitive Test (SKT)
The SKT (Syndrom-Kurz-Test) is a recognized short cognitive performance test used to detect attention and memory deficits. It features subtest norm values ranging from 0 to 3, with a total score ranging from 0 to 27, where higher scores indicate more severe cognitive impairment. The SKT assesses memory performance and attention based on processing speed.
The SKT (Syndrom-Kurz-Test) is a recognized short cognitive performance test used to detect attention and memory deficits. It features subtest norm values ranging from 0 to 3, with a total score ranging from 0 to 27, where higher scores indicate more severe cognitive impairment. The SKT assesses memory performance and attention based on processing speed.
Measured: 8 weeks
Secondary outcomes (1)
World health observational quality of life-BREF-100
Quality of life (QOL) is essential for understanding the subjective experience of mild cognitive impairment (MCI) and its impact on individuals. In the WHOQOL-BREF questionnaire, scores range from 0 (worst possible health) to 100 (best possible health), with higher scores indicating better QOL. Each domain score is calculated by taking the mean of items within that domain and then transformed linearly to a 0-100 scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start28 Feb 2025
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saliha Ashfaq, MS-NMPT*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867016
- Sponsor's protocol ID
- REC/MS-PT/O2029 Saliha Ashfaq
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2025
- Last updated
- 8 Apr 2026
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bidomain Cognitive and Aerobic Training on Cognitive Functioning in Mild Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT06867016
- Acronym / sponsor ID
- REC/MS-PT/O2029 Saliha Ashfaq
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognition, Old age, mild cognitive impairment, aerobic, cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 10 Mar 2025 (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.
The study aims to assess the effects of Bidomain cognitive and aerobic training on both cognitive functioning and quality of life in individuals with mild cognitive impairment.
Detailed description
The proposed study addresses a notable gap in the literature regarding the comparison between combined cognitive-aerobic training and cognitive training alone in improving cognitive function for patients with mild cognitive impairment (MCI). While previous studies have demonstrated the positive effects of both training methods on cognitive function independently, there is currently no research directly comparing their effectiveness when used together. The study aims to provide evidence on which treatment regime-combined cognitive-aerobic training or cognitive training alone-offers better outcomes for MCI patients. Aerobic training is known to enhance brain structure and function by strengthening neuronal connections, largely due to increased levels of brain-derived neurotrophic factor (BDNF) and enhanced vascularization, which stimulates hippocampal growth. On the other hand, cognitive training improves global cerebral functional connectivity, particularly activating the prefrontal cortex, which leads to better cognitive performance. Combining these training modalities may yield greater benefits than focusing on just one, offering a cost-effective, accessible approach that could significantly improve the quality of life and daily functioning for individuals with MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Cognitive & Aerobic Training Group | Experimental | Other: Combined Cognitive & Aerobics TrainingThe ACT combined training will consist of simultaneous aerobic exercise and cognitive training in a dual-task format. |
| Cognitive Training Group | Active comparator | Other: Cognitive TrainingCognitive training group include cognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older adults 60 years \& above
- With normal vision and color perception
- Independent Individual capable of carrying out daily tasks
- Individuals scoring 21-25 on the Mini-Mental State Examination (MMSE)
Key exclusion criteria (5 listed)
- Medication affecting the exercise capacity of individual
- Regular participation in aerobic training for the last six months
- Cardiovascular or other diseases that do not allow physical activity
- A diagnosed severe psychiatric disease (e.g., depression)
- Patients with cognitive impairment or other neurological impairments due to AD or dementia.
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 |
|---|---|---|
| Combined Cognitive & Aerobics TrainingThe ACT combined training will consist of simultaneous aerobic exercise and cognitive training in a dual-task format, conducted twice a week for 8 weeks. The aerobic training (AT) will consist of twice-weekly sessions that include yoga, brisk walking, pedaling exercises, and step aerobics, alongside cognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises. Each session will last approximately 20 minutes, and assessments will be performed at baseline, 4th week, and 8th week. | Other | Combined Cognitive & Aerobic Training Group |
| Cognitive TrainingCognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises. Each session will last approximately 20 minutes, and assessments will be performed at baseline, the 4th week, and the 8th week. | Other | Cognitive Training Group |
Primary outcome
Mini-mental state examination (MMSE)
Time frame: 8 weeks
The Mini-Mental State Examination (MMSE) is a widely used screening test for cognitive deficits, with scores ranging from 0 to 30. A score of 24 or below indicates potential cognitive impairment, particularly for patients aged 65 and older. The MMSE evaluates verbal abilities, where scores of 30-27 are considered normal, while lower scores indicate mild (26-21 points), moderate (20-10 points), or severe (9-0 points) dementia.
Short Cognitive Test (SKT)
Time frame: 8 weeks
The SKT (Syndrom-Kurz-Test) is a recognized short cognitive performance test used to detect attention and memory deficits. It features subtest norm values ranging from 0 to 3, with a total score ranging from 0 to 27, where higher scores indicate more severe cognitive impairment. The SKT assesses memory performance and attention based on processing speed. The SKT (Syndrom-Kurz-Test) is a recognized short cognitive performance test used to detect attention and memory deficits. It features subtest norm values ranging from 0 to 3, with a total score ranging from 0 to 27, where higher scores indicate more severe cognitive impairment. The SKT assesses memory performance and attention based on processing speed.
1 secondary outcome
World health observational quality of life-BREF-100
Time frame: 8 weeks
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 8 Apr 2026.
- 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.
Saliha Ashfaq, MS-NMPT* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Cognitive & Aerobics Training and Cognitive Training in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 5 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 8 Apr 2026. 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 Pakistan. 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?
Mini-mental state examination (MMSE) (time frame: 8 weeks). The study lists 2 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 8 Apr 2026.