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Completed

NCT Number: NCT06867016

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DHQ Chakwal

Chakwal, Punjab Province, 48800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined Cognitive & Aerobics Training

Other

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 Training

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. World health observational quality of life-BREF-100

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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