Study on the safety and effectiveness of reduced-exertion high-intensity interval training for non-ambulatory stroke patients' cardiorespiratory fitness: A prospective single-arm clinical trial.

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300072594

Enrollment

Unknown

Registered

2023-06-19

Start date

2023-06-12

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Intervention Group (Single arm):Stage 1: baseline training Stage 2: reduced-exertion high-intensity interval training.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ?Meet the diagnostic criteria for stroke. ?Stable vital signs. ?Age between 18 and 75 years. ?Onset of stroke between 15 days and 1 year. ?Functional level with a Functional Ambulation Category (FAC) score of 0-1, indicating the inability to walk independently without assistance from others. ?At least one lower limb capable of actively performing hip extension and knee extension movements. ?Cooperation with the measurement scale S5Q = 3, able to understand and actively participate in the assessment and training protocols. ?Signed informed consent form from the patient.

Exclusion criteria

Exclusion criteria: ?Patients with progressive stroke, hyperacute phase of stroke, transient ischemic attack, history of brain injury, encephalitis, tuberculous meningitis, or other central nervous system involvement. ?Patients with acute coronary syndrome, decompensated heart failure, uncontrolled severe arrhythmias, high-degree atrioventricular block, severe valvular heart disease, hypertrophic obstructive cardiomyopathy, active myocarditis, pericarditis, or other severe cardiac diseases. ?Patients with severe liver or kidney dysfunction, including glomerular filtration rate (GFR) < 15%, alanine aminotransferase (ALT) = 200 U/L, or aspartate aminotransferase (AST) = 200 U/L. ?Patients with other serious conditions, such as malignant tumors, end-stage chronic kidney disease, mental disorders, severe malnutrition, etc. ?Patients with unhealed lower limb fractures or severe osteoporosis, and those with high muscle tone graded as 2-4 according to the Ashworth scale. ?Untreated patients with lower limb deep vein thrombosis. ?Pregnant or lactating women. ?Patients concurrently participating in other drug or medical device clinical trials.

Design outcomes

Primary

Measure	Time frame
Peak oxygen uptake (VO2peak) improved efficiency;	—

Secondary

Measure	Time frame
Activities of daily living;Limb mobility;Body fat rate;muscle mass;Serum cholesterol;FBG(fasting blood-glucose);Morning blood pressure;	—

Countries

China

Contacts

Public ContactMingchao Zhou

Shenzhen Second People's Hospital

zhoumc06@email.szu.edu.cn+86 189 9891 2628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026