NCT07623954

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 21, 2026

Last Update Submit

June 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    A total of 8 months from the beginning to the end

Secondary Outcomes (1)

  • Brain functional connectivity

    A total of 8 months from the beginning to the end

Study Arms (4)

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.

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.

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.

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.

Other: health education materials

Interventions

exercise programm

Baduanjin groupBrisk walking groupResistance band group

health education materials

Control group

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai University of Sport

Shanghai, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 3, 2026

Study Start

June 30, 2025

Primary Completion

January 10, 2026

Study Completion

January 20, 2026

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations