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

NCT07772947 | Completed

• 2 other identifiers: WH6H-2024-StrokeRCT-01WX23Q45
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Cognitive Impairment

Keywords

stroke; working memory; hyperbaric oxygen therapy; functional near-infrared spectroscopy; aerobic exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (day 0), post-intervention (day 14)

Secondary Outcomes (1)

• Prefrontal cortical oxygenation level measured by fNIRS

  Baseline (day 0), post-intervention (day 14)

Study Arms (4)

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.

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.

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.

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.

Behavioral: Conventional rehabilitation therapy; Behavioral: Moderate-intensity aerobic exercise; Behavioral: Hyperbaric Oxygen Therapy (HBOT); Behavioral: Combined aerobic exercise and hyperbaric oxygen therapy

Interventions

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.

Combined Hyperbaric Oxygen + Aerobic Exercise Group; Conventional Rehabilitation Control Group; Hyperbaric Oxygen Therapy Group; Moderate-intensity Aerobic Exercise Group

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.

Combined Hyperbaric Oxygen + Aerobic Exercise Group; Moderate-intensity Aerobic Exercise Group

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 Hyperbaric Oxygen + Aerobic Exercise Group; Hyperbaric Oxygen Therapy Group

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.

Combined Hyperbaric Oxygen + Aerobic Exercise Group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University: lead

Study Sites (1)

Wuhan Sixth Hospital

Wuhan, Hubei, 430070, China

Location

Related Links

• Official hospital website for research institution

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Weixiang Qin, PhD

  Wuhan Sixth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind design: only the outcome assessors who conducted cognitive tests, fNIRS scanning and blood index detection were blinded to group allocation. Participants, rehabilitation therapists and researchers were unblinded due to distinguishable intervention modes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: December 6, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)