Baduanjin Sequential Therapy and Cardiac Function of AMI With Reduced EF After PCI

NCT ID: NCT05201274

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2023-02-11

Brief Summary

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Acute myocardial infarction (AMI) is one of the leading causes of death around the world, with the potential for substantial morbidity and mortality. The increasing evidence indicates that exercise training has beneficial effects on LV remodelling in post-MI patients with greater benefits occurring when training earlier following MI, among which the earliest time for rehabilitation is one week after myocardial infarction. However, the effect of Baduanjin sequential therapy for patients after one week of AMI has yet to be assessed. Therefore, the aim of this study is to assess the impact of Baduanjin sequential therapy on cardiac and physical function in patients with AMI and reduced ejection fraction after primary PCI.

Detailed Description

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Conditions

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AMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Baduanjin sequential therapy

Group Type EXPERIMENTAL

Baduanjin sequential therapy

Intervention Type BEHAVIORAL

A detailed description of a standardized Baduanjin exercise protocol complied with the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003.

Aerobic exercise

Group Type ACTIVE_COMPARATOR

Aerobic exercise

Intervention Type BEHAVIORAL

Participants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located at home or cardiac rehabilitation centre lasting 3 months. The program is consistent with the current recommended guidelines of moderate-intensity exercises for MI.

Interventions

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Baduanjin sequential therapy

A detailed description of a standardized Baduanjin exercise protocol complied with the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003.

Intervention Type BEHAVIORAL

Aerobic exercise

Participants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located at home or cardiac rehabilitation centre lasting 3 months. The program is consistent with the current recommended guidelines of moderate-intensity exercises for MI.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Acute myocardial infarction undergoing primary percutaneous coronary intervention;
* Aged 18 years or over and under 80 years;
* 35% \< LVEF \< 50% and LV \< 65mm;
* With informed consents

Exclusion Criteria

* Severe symptomatic congestive heart failure (KILLIP cardiac function class III-IV);
* Malignant arrhythmias (ventricular fibrillation, ventricular tachycardia, frequent multiple source ventricular premature);
* Uncontrolled hypertension (systolic blood pressure greater than 160mmhg, diastolic blood pressure greater than 100mmhg);
* Life-threatening diseases with limited life expectancy \<6 months;
* Inability or difficulty to exercise;
* Participation in other clinical trials
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenyang Northern Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han Yaling

Director of cardiology, General Hospital of Northern Theater Command

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meili Liu, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Shenyang Military Region

Locations

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General Hospital of Shenyang Military Region

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Meili Liu, MD

Role: CONTACT

86-18940193302

Yaling Han, MD

Role: CONTACT

86-24-23922184

Facility Contacts

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Yi Li, MD

Role: primary

+86-24-28897309

References

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Perelshtein Brezinov O, Klempfner R, Zekry SB, Goldenberg I, Kuperstein R. Prognostic value of ejection fraction in patients admitted with acute coronary syndrome: A real world study. Medicine (Baltimore). 2017 Mar;96(9):e6226. doi: 10.1097/MD.0000000000006226.

Reference Type RESULT
PMID: 28248882 (View on PubMed)

Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

Reference Type RESULT
PMID: 28886621 (View on PubMed)

Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010 Jun 10;362(23):2155-65. doi: 10.1056/NEJMoa0908610.

Reference Type RESULT
PMID: 20558366 (View on PubMed)

Haykowsky M, Scott J, Esch B, Schopflocher D, Myers J, Paterson I, Warburton D, Jones L, Clark AM. A meta-analysis of the effects of exercise training on left ventricular remodeling following myocardial infarction: start early and go longer for greatest exercise benefits on remodeling. Trials. 2011 Apr 4;12:92. doi: 10.1186/1745-6215-12-92.

Reference Type RESULT
PMID: 21463531 (View on PubMed)

Other Identifiers

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BST-AMI

Identifier Type: -

Identifier Source: org_study_id

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