Cognitive ImpairmentNCT07854444
Beta-1 Band Functional Connectivity Mediates the Effects of Acute Exercise on Cognitive Flexibility in Older Adults With Cognitive Impairment: A Randomized Controlled Trial
A study testing Baduanjin, Brisk walking and Resistance band in people with Cognitive Impairment and Cognitive Flexibility, run by Shanghai University of Sport at 1 site in China.
Trial summary
Objective: The effects of different exercise modalities (mind-body, aerobic, and resistance training) on cognitive flexibility and brain functional connectivity in cognitively impaired older adults are unknown, and the mechanistic relationships linking acute exercise, cognitive flexibility, and neural connectivity… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Cognitive Flexibility, Brain Functional Connectivity
- What is being tested?
- Baduanjin, Brisk walking and Resistance band
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 12 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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;
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. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai University of Sport
Shanghai
Feng Ding, 18106300274, 2321151118@sus.edu.cn
About this study
Objective: The effects of different exercise modalities (mind-body, aerobic, and resistance training) on cognitive flexibility and brain functional connectivity in cognitively impaired older adults are unknown, and the mechanistic relationships linking acute exercise, cognitive flexibility, and neural connectivity remain unclear.
Methods: A total of 60 older adults with cognitive impairment were recruited and randomly assigned to a Baduanjin group (n = 15), a brisk walking group (n = 15), a resistance band group (n = 15), or a control group (n = 15). Five-minute resting-state electroencephalography signals were collected and cognitive flexibility was assessed before and after the intervention. All exercise interventions were performed at a moderate intensity and lasted 30 minutes.
- Being tested
- Baduanjin, Brisk walking, Resistance band, 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.
BaduanjinOther
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.
Brisk walkingOther
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.
Resistance bandOther
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.
health education materialsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 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: Baduanjin |
| Group B | 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: Brisk walking |
| Group C | 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: Resistance band |
| Group D | 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 2 weeks 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 2 weeks 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 posted2 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion11 Oct 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
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 (estimated)
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
- NCT07854444
- Sponsor's protocol ID
- DF2026002
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-1 Band Functional Connectivity Mediates the Effects of Acute Exercise on Cognitive Flexibility in Older Adults With Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07854444
- Acronym / sponsor ID
- DF2026002
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai University of SportUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 11 Oct 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 2 Oct 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.
Objective: The effects of different exercise modalities (mind-body, aerobic, and resistance training) on cognitive flexibility and brain functional connectivity in cognitively impaired older adults are unknown, and the mechanistic relationships linking acute exercise, cognitive flexibility, and neural connectivity remain unclear.
Methods: A total of 60 older adults with cognitive impairment were recruited and randomly assigned to a Baduanjin group (n = 15), a brisk walking group (n = 15), a resistance band group (n = 15), or a control group (n = 15). Five-minute resting-state electroencephalography signals were collected and cognitive flexibility was assessed before and after the intervention. All exercise interventions were performed at a moderate intensity and lasted 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 |
|---|---|---|
| Group A | Experimental | Other: BaduanjinThis 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. |
| Group B | Experimental | Other: Brisk walkingThis 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. |
| Group C | Experimental | Other: Resistance bandThe 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. |
| Group D | 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 |
|---|---|---|
| BaduanjinThis 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. | Other | Group A |
| Brisk walkingThis 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. | Other | Group B |
| Resistance bandThe 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. | Other | Group C |
| 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. | Other | Group D |
Primary outcome
Cognitive flexibility
Time frame: A total of 2 weeks 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 2 weeks from the beginning to the end
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin, Brisk walking and Resistance band 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 6 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: opening soon, as of the sponsor's last update on 2 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Ding (18106300274, 2321151118@sus.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive flexibility (time frame: A total of 2 weeks 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 2 Oct 2026.