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Completed

NCT Number: NCT07623954

The Effects of Single Exercise Sessions on Cognitive Flexibility and Brain Functional Connectivity in Older Adults With Cognitive Impairment

Objectives: To investigate the effects of different forms (physical and mental, aerobic and resistance) of single exercise on the cognitive flexibility and brain functional connectivity of elderly individuals with cognitive impairment.

Clinical trail Methods: This study employed a single-blind, multi-center randomized controlled trial. Sixty elderly individuals with cognitive impairment were recruited and randomly divided into the Qigong group (15 participants), the brisk walking group (15 participants), the elastic band group (15 participants), and the control group (15 participants). Before and after the intervention, 5-minute resting-state electroencephalogram signals were collected and cognitive flexibility tests were conducted. The Qigong group, the brisk walking group, and the elastic band group received single sessions of Qigong, brisk walking, and elastic band exercises respectively, while the control group received health education. The exercise intensity was moderate (target heart rate was 64%-76% of the maximum heart rate), and the exercise duration was 30 minutes.

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Key information

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai University of Sport

Shanghai, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 60 years old, gender not restricted;
  • Patients or their guardians report subjective cognitive decline;
  • Montreal Cognitive Function Assessment Scale < 26 points;
  • Duration of cognitive dysfunction ≥ 6 months;
  • Willing to sign the informed consent form;
  • Good physical condition and able to complete the test;
  • Right-handed.

Exclusion criteria

  • History of severe mental disorders (severe depression, schizophrenia, etc.);
  • Using drugs that affect cognition (such as sedatives, antidepressants, etc.);
  • Limited language ability;
  • Consumed caffeine or alcohol the day before the test;
  • Suffering from serious diseases or injuries that make participation in the test inappropriate.

Treatment and study plan

Exercise training

Other

exercise programm

health education materials

Other

health education materials

Primary outcomes

  1. Cognitive flexibility

    Time frame: A total of 8 months from the beginning to the end

    Cognitive flexibility was assessed using the More-odd-shifting task paradigm, which was designed with E-prime software. The testing environment was quiet, well ventilated and moderately lit. The stimuli used in the More-odd-shifting task were red or green Arabic numerals from 1 to 9, excluding 5. Participants were required to make key-press responses according to the task instructions when the stimuli appeared. The More-odd-shifting task consisted of three conditions: Condition 1, judgment of numerical magnitude; Condition 2, judgment of parity; and Condition 3, mixed judgment of numerical magnitude and parity.

Secondary outcomes

  1. Brain functional connectivity

    Time frame: A total of 8 months from the beginning to the end

    Brain functional connectivity analysis was performed using MATLAB scripts, and graph-theoretical analysis was carried out using the BrainNet Viewer toolbox. Phase locking value (PLV) was used, and brain functional connectivity was evaluated from two dimensions: connectivity strength and density. In this study, PLV was calculated for the δ, θ, α1, α2, β1 and β2 bands of resting-state EEG using MATLAB, and the formula is shown in Equation (1). Here, i is the imaginary unit, Δt is the time interval between two consecutive samples, and N is the total number of samples. PLV is an index used to quantify phase synchrony in EEG signals and assesses whether two signals maintain a relatively stable phase relationship over time. Its value ranges from 0 to 1, where 1 indicates complete synchrony and 0 indicates no synchrony. PLV is commonly used to investigate phase synchrony between different brain regions, particularly functional connectivity related to neural oscillations.

Sponsors and collaborators

Lead sponsor

Shanghai University of Sport

Other

Registry information

Official study title

The Effects of Different Forms of Single Exercise Sessions on Cognitive Flexibility and Brain Functional Connectivity in Older Adults With Cognitive Impairment: A Single-Blind, Multicenter Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2026
Registry last updated
Jun 3, 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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