Skip to main content
OpenTrials
Completed

NCT Number: NCT07772947

Effects of Hyperbaric Oxygen Combined With Aerobic Exercise on Working Memory Among Stroke Patients

This single-center randomized controlled trial enrolled stroke patients with working memory impairment. Participants were randomly divided into the hyperbaric oxygen combined low-intensity focused ultrasound intervention group and the conventional rehabilitation control group. The intervention lasted for a fixed course, and indicators including working memory performance and prefrontal cortex activation detected by fNIRS were compared before and after treatment. The study aims to verify whether combined intervention can better improve cognitive function in stroke survivors. All subjects signed informed consent and obtained ethical approval before enrollment.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Sixth Hospital

Wuhan, Hubei, 430070, China

About this study

A prospective single-center randomized controlled study was conducted among inpatients with ischemic stroke complicated with working memory deficit admitted to the Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University from December 6, 2024 to May 1, 2025. Eligible participants were randomly allocated into two groups: the experimental group received hyperbaric oxygen therapy plus low-intensity focused ultrasound neuromodulation on the prefrontal cortex, while the control group received routine occupational therapy and cognitive rehabilitation training with equal treatment duration. The primary outcomes were 2-back task accuracy and reaction time assessed by neurobehavioral tests; secondary outcomes included oxygenated hemoglobin concentration in bilateral DLPFC monitored by functional near-infrared spectroscopy before intervention, after 2 weeks and after the full course. Demographic data, stroke lesion characteristics and adverse events were recorded synchronously. Statistical analysis adopted independent sample t-test and repeated-measures ANOVA to compare inter-group and intra-group differences. The whole research scheme was approved by the hospital ethics committee, and written informed consent was acquired from each participant before enrollment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • First-ever ischemic stroke confirmed by cranial MRI/CT;
  • Age 65-85 years old;
  • MoCA score 18-26 points (mild cognitive impairment after stroke);
  • Right-handed, able to complete 2-back cognitive task and fNIRS detection;
  • Signed written informed consent voluntarily.

Exclusion criteria

  • History of dementia, traumatic brain injury or other central nervous system diseases;
  • Severe visual/auditory impairment unable to finish cognitive assessment;
  • Contraindications for hyperbaric oxygen therapy (untreated pneumothorax, severe emphysema etc.);
  • Severe cardiac insufficiency or unstable vital signs;
  • Taking cognitive improvement drugs within 1 month before enrollment;
  • Dropping out voluntarily during the 14-day intervention.

Treatment and study plan

Conventional rehabilitation therapy

Behavioral

Routine physical rehabilitation including physical factor therapy, occupational therapy and basic motor training, 5 sessions per week, lasting for 14 consecutive days, no additional aerobic exercise or hyperbaric oxygen treatment.

Moderate-intensity aerobic exercise

Behavioral

Sitting stationary bicycle training: 4-minute warm-up, 15-minute moderate-intensity cycling (heart rate controlled at 60%-69% of predicted maximum heart rate), 3-minute relaxation after training; implemented 5 times weekly for 14 days, combined with conventional rehabilitation.

Hyperbaric Oxygen Therapy (HBOT)

Behavioral

90-minute hyperbaric oxygen treatment under 2.0 ATA pressure, patients inhale pure oxygen through facial mask with short air breaks; 5 sessions weekly for 14 days, carried out together with conventional rehabilitation.

Combined aerobic exercise and hyperbaric oxygen therapy

Behavioral

Moderate-intensity aerobic exercise and hyperbaric oxygen therapy are performed sequentially on the same day, combined with conventional rehabilitation, 5 sessions weekly for 14 consecutive days.

Primary outcomes

  1. 2-back task working memory reaction time

    Time frame: Baseline (day 0), post-intervention (day 14)

    Outcome assessors were blinded to group allocation. The reaction time of participants completing the 2-back cognitive task was recorded to quantify working memory performance before and after intervention among the four groups.

Secondary outcomes

  1. Prefrontal cortical oxygenation level measured by fNIRS

    Time frame: Baseline (day 0), post-intervention (day 14)

    Regional cerebral oxygen saturation of bilateral DLPFC was collected during cognitive tasks to reflect neural activation intensity.

Sponsors and collaborators

Lead sponsor

Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

Other

Registry information

Official study title

Effects of Combined Hyperbaric Oxygen Therapy and Moderate-Intensity Aerobic Exercise on Working Memory in Stroke Patients: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2026
Registry last updated
Aug 19, 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.

Published trials that share one or more normalized conditions with this study.