Effects of Bidomain Cognitive and Aerobic Training on Cognitive Functioning in Mild Cognitive Impairment.

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT06867016
• Lead Sponsor: Riphah International University

Brief 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.

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 Timeline

• Study Start: 2025-02-28
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-08-28
• Study Completion: 2025-08-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mini-mental state examination (MMSE)	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)	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.

Secondary Outcome Measures

Name	Time	Method
World health observational quality of life-BREF-100	8 weeks	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

Trial Locations

Locations (1)

DHQ Chakwal; 🇵🇰 Chakwal, Punjab, Pakistan