Cognitive ImpairmentNCT07623954
The Effects of Single Exercise Sessions on Cognitive Flexibility and Brain Functional Connectivity in Older Adults With Cognitive Impairment
A study testing EXERCISE TRAINING and health education materials in people with Cognitive Impairment and Cognitive Flexibility, run by Shanghai University of Sport at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Cognitive Impairment, Cognitive Flexibility
- What is being tested?
- EXERCISE TRAINING and health education materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 20 Jan 2026
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Cognitive Impairment, Cognitive Flexibility
- Being tested
- EXERCISE TRAINING, health education materials
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAININGOther
exercise programm
health education materialsOther
health education materials
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin group | Experimental | This study adopted the Baduanjin Health Qigong standard issued by the General Administration of Sport of China in 2003. . The exercise intervention lasted 30 min in total, including a 2-min preparation phase, a 26-min main phase and a 2-min cool-down phase. Two weeks before the formal intervention, participants received training from a martial arts professional coach, and only those who had achieved fluent and proficient performance of the movements were allowed to take part in the formal intervention. Participants were required not to engage in any exercise during the 3 days before the intervention. The Baduanjin group received movement instruction from a professional martial arts coach and performed the exercise in an indoor dance room. Receives: Other: EXERCISE TRAINING |
| Brisk walking group | Experimental | This study adopted the Brisk Walking standard issued by the General Administration of Sport of China in 2017. A treadmill manufactured by Topkang Technology Co., Ltd. (model: SJAI) was used. The exercise intervention lasted 30 min in total, including a 2-min preparation phase, a 26-min main phase and a 2-min cool-down phase. Before the intervention, participants received instruction and training from a professional track-and-field coach, and only those who had achieved fluent and proficient performance of the movements were allowed to participate in the formal intervention. Participants were required not to engage in any exercise during the 3 days before the intervention. The brisk walking group received movement instruction from a professional track-and-field coach and performed the exercise on an indoor treadmill. Receives: Other: EXERCISE TRAINING |
| Resistance band group | Experimental | The resistance exercise programme in this study was based on the framework of the American College of Sports Medicine (ACSM) guidelines. A portable and safe resistance band (TheraBand progressive resistance band, USA) was used as the intervention tool. The resistance-band resistance training consisted of 10 exercises in total, including 4 upper-limb movements (seated chest press, seated reverse fly, seated biceps curl and seated shoulder press) and 6 lower-limb movements (seated knee lift, seated knee extension, seated knee flexion, seated leg press, seated hip abduction and standing calf raise). Each movement was performed for 2 sets of 12 repetitions. Rest intervals were 30-60 s within sets and 30-60 s between sets, and the movement tempo was controlled at 2 s for the eccentric phase and 2 s for the concentric phase. The resistance-band group received movement instruction from a professional fitness coach and performed the exercise in an indoor activity room. Receives: Other: EXERCISE TRAINING |
| Control group | Active comparator | After arrival, participants in the control group watched health education materials and received health education at the community activity center. Detailed descriptions of the exercise interventions for the four groups are provided in the Supplementary Materials. Receives: Other: health education materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive flexibility
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.
Measured: A total of 8 months from the beginning to the end
Secondary outcomes (1)
Brain functional connectivity
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.
Measured: A total of 8 months from the beginning to the end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start30 Jun 2025
- Primary completion10 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Feng, Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623954
- Sponsor's protocol ID
- DF2026001
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07623954
- Acronym / sponsor ID
- DF2026001
- Conditions
- Cognitive Impairment, Cognitive Flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai University of SportUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 3 Jun 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baduanjin group | Experimental | Other: EXERCISE TRAININGThis study adopted the Baduanjin Health Qigong standard issued by the General Administration of Sport of China in 2003. . The exercise intervention lasted 30 min in total, including a 2-min preparation phase, a 26-min main phase and a 2-min cool-down phase. Two weeks before the formal intervention, participants received training from a martial arts professional coach, and only those who had achieved fluent and proficient performance of the movements were allowed to take part in the formal intervention. Participants were required not to engage in any exercise during the 3 days before the intervention. The Baduanjin group received movement instruction from a professional martial arts coach and performed the exercise in an indoor dance room. |
| Brisk walking group | Experimental | Other: EXERCISE TRAININGThis study adopted the Brisk Walking standard issued by the General Administration of Sport of China in 2017. A treadmill manufactured by Topkang Technology Co., Ltd. (model: SJAI) was used. The exercise intervention lasted 30 min in total, including a 2-min preparation phase, a 26-min main phase and a 2-min cool-down phase. Before the intervention, participants received instruction and training from a professional track-and-field coach, and only those who had achieved fluent and proficient performance of the movements were allowed to participate in the formal intervention. Participants were required not to engage in any exercise during the 3 days before the intervention. The brisk walking group received movement instruction from a professional track-and-field coach and performed the exercise on an indoor treadmill. |
| Resistance band group | Experimental | Other: EXERCISE TRAININGThe resistance exercise programme in this study was based on the framework of the American College of Sports Medicine (ACSM) guidelines. A portable and safe resistance band (TheraBand progressive resistance band, USA) was used as the intervention tool. The resistance-band resistance training consisted of 10 exercises in total, including 4 upper-limb movements (seated chest press, seated reverse fly, seated biceps curl and seated shoulder press) and 6 lower-limb movements (seated knee lift, seated knee extension, seated knee flexion, seated leg press, seated hip abduction and standing calf raise). Each movement was performed for 2 sets of 12 repetitions. Rest intervals were 30-60 s within sets and 30-60 s between sets, and the movement tempo was controlled at 2 s for the eccentric phase and 2 s for the concentric phase. The resistance-band group received movement instruction from a professional fitness coach and performed the exercise in an indoor activity room. |
| Control group | Active comparator | Other: health education materialsAfter arrival, participants in the control group watched health education materials and received health education at the community activity center. Detailed descriptions of the exercise interventions for the four groups are provided in the Supplementary Materials. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| EXERCISE TRAININGexercise programm | Other | Baduanjin group, Brisk walking group, Resistance band group |
| health education materialshealth education materials | Other | Control group |
Primary outcome
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.
1 secondary outcome
Brain functional connectivity
Time frame: A total of 8 months from the beginning to the end
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 3 Jun 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.
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 EXERCISE TRAINING and health education materials in people with Cognitive Impairment and Cognitive Flexibility, run by Shanghai University of Sport at 1 site in China.
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 7 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 3 Jun 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 China. 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?
Cognitive flexibility (time frame: A total of 8 months from the beginning to the end). 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 3 Jun 2026.