StrokeNCT07772947

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

A study testing Conventional rehabilitation therapy, Moderate-intensity aerobic exercise and Hyperbaric Oxygen Therapy (HBOT) in people with Stroke and Cognitive Impairment, run by Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 to 85 years
Conditions the study is for: Stroke, Cognitive Impairment
What is being tested?: Conventional rehabilitation therapy, Moderate-intensity aerobic exercise and Hyperbaric Oxygen Therapy (HBOT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: 6 Dec 2024to 1 May 2025
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 65 to 85 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Wuhan Sixth Hospital
Wuhan, Hubei, 430070

Other trials in China

About this study

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

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.

Read the detailed description

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.

Conditions: Stroke, Cognitive Impairment
Being tested: Conventional rehabilitation therapy, Moderate-intensity aerobic exercise, Hyperbaric Oxygen Therapy (HBOT), Combined aerobic exercise and hyperbaric oxygen therapy
Keywords: stroke, working memory, hyperbaric oxygen therapy, functional near-infrared spectroscopy, aerobic exercise
Medical subject headings: Stroke, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conventional rehabilitation therapyBehavioural
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 exerciseBehavioural
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)Behavioural
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 therapyBehavioural
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.

Study groups in NCT07772947
Study group	Role	What they receive
Conventional Rehabilitation Control Group	Active comparator	Receive routine basic rehabilitation therapy only, without aerobic exercise or hyperbaric oxygen intervention, 5 sessions per week for 14 consecutive days. Receives: Behavioral: Conventional rehabilitation therapy
Moderate-intensity Aerobic Exercise Group	Experimental	Stationary bicycle aerobic training combined with conventional rehabilitation; training includes 4-min warm-up, 15-min moderate-intensity cycling and 3-min relaxation, 5 sessions weekly for 14 days. Receives: Behavioral: Conventional rehabilitation therapy; Behavioral: Moderate-intensity aerobic exercise
Hyperbaric Oxygen Therapy Group	Experimental	90-minute hyperbaric oxygen treatment (2.0 ATA, pure oxygen via mask) combined with conventional rehabilitation, 5 sessions weekly for 14 days. Receives: Behavioral: Conventional rehabilitation therapy; Behavioral: Hyperbaric Oxygen Therapy (HBOT)
Combined Hyperbaric Oxygen + Aerobic Exercise Group	Experimental	Sequential implementation of aerobic exercise and hyperbaric oxygen therapy on the same day, combined with conventional rehabilitation, 5 sessions weekly for 14 days. Receives: Behavioral: Conventional rehabilitation therapy; Behavioral: Moderate-intensity aerobic exercise; Behavioral: Hyperbaric Oxygen Therapy (HBOT); Behavioral: Combined aerobic exercise and hyperbaric oxygen therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

2-back task working memory reaction time
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.
Measured: Baseline (day 0), post-intervention (day 14)

Secondary outcomes (1)

Prefrontal cortical oxygenation level measured by fNIRS
Regional cerebral oxygen saturation of bilateral DLPFC was collected during cognitive tasks to reflect neural activation intensity.
Measured: Baseline (day 0), post-intervention (day 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 20241 May 2025

First posted19 Aug 2026
Study start6 Dec 2024
Primary completion1 May 2025
Study completion1 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies 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
Model description: This is a single-center 4-arm parallel randomized controlled trial. Participants with stroke and working memory impairment were randomly allocated into 4 groups: conventional rehabilitation control group, moderate-intensity aerobic exercise group, hyperbaric oxygen therapy group, combined hyperbaric oxygen + aerobic exercise group. A total of 50 subjects were enrolled and completed the 14-day intervention course.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07772947
Sponsor's protocol ID: WH6H-2024-StrokeRCT-01
Other IDs: WX23Q45
Status last verified: Aug 2026
First submitted: 14 Aug 2026
Last updated: 20 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Combined Hyperbaric Oxygen Therapy and Moderate-Intensity Aerobic Exercise on Working Memory in Stroke Patients: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07772947
Acronym / sponsor ID: WH6H-2024-StrokeRCT-01
Conditions: Stroke, Cognitive Impairment
Keywords: stroke, working memory, hyperbaric oxygen therapy, functional near-infrared spectroscopy, aerobic exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan UniversityUniversity, hospital or other
Study start: 6 Dec 2024 (actual)
Primary completion: 1 May 2025 (actual)
Study completion: 1 May 2025 (actual)
First posted: 19 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: This is a single-center 4-arm parallel randomized controlled trial. Participants with stroke and working memory impairment were randomly allocated into 4 groups: conventional rehabilitation control group, moderate-intensity aerobic exercise group, hyperbaric oxygen therapy group, combined hyperbaric oxygen + aerobic exercise group. A total of 50 subjects were enrolled and completed the 14-day intervention course.

Arm	Type	Receives
Conventional Rehabilitation Control Group	Active comparator	Behavioral: Conventional rehabilitation therapyReceive routine basic rehabilitation therapy only, without aerobic exercise or hyperbaric oxygen intervention, 5 sessions per week for 14 consecutive days.
Moderate-intensity Aerobic Exercise Group	Experimental	Behavioral: Conventional rehabilitation therapy, Behavioral: Moderate-intensity aerobic exerciseStationary bicycle aerobic training combined with conventional rehabilitation; training includes 4-min warm-up, 15-min moderate-intensity cycling and 3-min relaxation, 5 sessions weekly for 14 days.
Hyperbaric Oxygen Therapy Group	Experimental	Behavioral: Conventional rehabilitation therapy, Behavioral: Hyperbaric Oxygen Therapy (HBOT)90-minute hyperbaric oxygen treatment (2.0 ATA, pure oxygen via mask) combined with conventional rehabilitation, 5 sessions weekly for 14 days.
Combined Hyperbaric Oxygen + Aerobic Exercise Group	Experimental	Behavioral: Conventional rehabilitation therapy, Behavioral: Moderate-intensity aerobic exercise, Behavioral: Hyperbaric Oxygen Therapy (HBOT), Behavioral: Combined aerobic exercise and hyperbaric oxygen therapySequential implementation of aerobic exercise and hyperbaric oxygen therapy on the same day, combined with conventional rehabilitation, 5 sessions weekly for 14 days.

Who may qualify

Ages: 65 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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;

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
Conventional rehabilitation therapyRoutine 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.	Behavioural	Combined Hyperbaric Oxygen + Aerobic Exercise Group, Conventional Rehabilitation Control Group, Hyperbaric Oxygen Therapy Group, Moderate-intensity Aerobic Exercise Group
Moderate-intensity aerobic exerciseSitting 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.	Behavioural	Combined Hyperbaric Oxygen + Aerobic Exercise Group, Moderate-intensity Aerobic Exercise Group
Hyperbaric Oxygen Therapy (HBOT)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.	Behavioural	Combined Hyperbaric Oxygen + Aerobic Exercise Group, Hyperbaric Oxygen Therapy Group
Combined aerobic exercise and hyperbaric oxygen therapyModerate-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.	Behavioural	Combined Hyperbaric Oxygen + Aerobic Exercise Group

Primary outcome

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.

1 secondary outcome

Prefrontal cortical oxygenation level measured by fNIRS
Time frame: Baseline (day 0), post-intervention (day 14)

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 20 Aug 2026.
Official hospital website for research institutionLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Stroke

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.

Weixiang Qin, PhD principal investigator

Wuhan Sixth Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 6 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 20 Aug 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?

2-back task working memory reaction time (time frame: Baseline (day 0), post-intervention (day 14)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07772947.

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 20 Aug 2026.