A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease

NCT06681506 | Recruiting DMC

• 1 other identifier: Rehabilitation-ICM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac rehabilitation is an important link in cardiovascular disease. This study mainly explores the effectiveness of new cardiac rehabilitation therapy (early respiratory rehabilitation, phase I rehabilitation, exercise therapy, external counterpulsation, extracorporeal shock wave, etc.) on patients with ischemic heart disease such as coronary heart disease and heart failure, and the compliance of home rehabilitation compared with traditional cardiac rehabilitation therapy (traditional exercise rehabilitation, rehabilitation education, etc.).

Conditions

Ischemic Heart Disease; Cardiac Rehabilitation

Keywords

coronary atherosclerotic cardiopathy; Cardiac Shock Wave Therapy; exercise rehabilitation; cardiac rehabilitation; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline myocardial infarct area at 6 months

  The location and extent of myocardial infarction were determined by D-SPECT.

  1 day of inclusions and 6 months after the first treatment.

Secondary Outcomes (2)

• 6 months hemodynamic changes in relative to the baseline

  1 day of inclusions and 6 months after the first treatment.

• Change from baseline peak oxygen consumption at 6 months

  1 day of inclusions and 6 months after the first treatment.

Other Outcomes (2)

• Major adverse cardiovascular events (MACE）

  From the date of inclusion until the date of documented adverse events with 6 months

• Other treatment-related adverse reactions

  From the date of inclusion until the date of treatment-related adverse reactions within 6 months

Study Arms (2)

The new rehabilitation group

EXPERIMENTAL

Routine drug therapy + new cardiac rehabilitation therapy, a new cardiac rehabilitation treatment reference guide requirements, according to the actual circumstance of patients treated with 1-3 months intervention.

Device: Metronomic breathing, exercise rehabilitation, external counterpulsation, extracorporeal shock wave.

The traditional rehabilitation group.

ACTIVE COMPARATOR

Routine drug therapy + traditional cardiac rehabilitation therapy, traditional cardiac rehabilitation treatment for reference domestic and international guidelines and consensus, according to the actual circumstance of patients treated with 1-3 months intervention.

Device: bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation

Interventions

Metronomic breathing, exercise rehabilitation, external counterpulsation, extracorporeal shock wave. DEVICE

Phase I rehabilitation(Metronomic breathing，exercise rehabilitation）,Phase II rehabilitation (exercise rehabilitation, external counterpulsation, extracorporeal shock) wave.)

The new rehabilitation group

bedside rehabilitation and breathing, balance, flexibility, movement rehabilitation DEVICE

Phase I rehabilitation (bedside rehabilitation, breathing rehabilitation), Phase II rehabilitation (breathing, balance, flexibility, movement)

The traditional rehabilitation group.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 85 years old
• Female subjects no pregnancy
• The main admission diagnosis of ischemic heart disease (coronary heart disease, myocardial infarction, ischemic heart failure, etc.)
• The need for cardiac rehabilitation treatment

You may not qualify if:

• acute respiratory distress syndrome (ARDS);
• acute episode of COPD;
• uncontrolled pulmonary infection;
• acute heart failure; acute pulmonary embolism;
• acute myocarditis/pericarditis;
• severe arrhythmia (degree II or III atrioventricular block, atrial flutter, or atrial fibrillation);
• sternotomy, rib fracture, thoracic deformity, or other neurological diseases that may affect respiratory muscles

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead
• Shanghai Municipal Science and Technology Commission: collaborator

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Exercise Therapy; Counterpulsation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Assisted Circulation; Surgical Procedures, Operative

Central Study Contacts

liujing liu, MD, PhD

CONTACT

+86 18917684041; liuweijing98@sina.com

zhaoxin zhu, B.D

CONTACT

+86 13162999337; zhaoxinzhu0728@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 8, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)