Effect of Mobile-Based Home Cardiac Rehabilitation on Coronary Plaque (MHCRT)
Effect of Mobile Internet Technology-Based Home Cardiac Rehabilitation on Coronary Artery Plaque in Patients With Mild to Moderate Stenosis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Xue Feng
- Telefonnummer: +86-10-8839-6216
- E-mail: 29611290@qq.com
Undersøgelse Kontakt Backup
- Navn: Shumin Zhang
- Telefonnummer: +86-10-8839-6216
- E-mail: zhangshumin0302@163.com
Studiesteder
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Beijing, Kina, 100037
- Rekruttering
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
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Kontakt:
- Xue Feng
- Telefonnummer: +86-10-8839-6216
- E-mail: 29611290@qq.com
-
Kontakt:
- Shumin Zhang
- Telefonnummer: +86-10-8839-6216
- E-mail: zhangshumin0302@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
1.Diagnosis of mild-to-moderate coronary artery stenosis: presence of plaque in any coronary artery causing mild (<50%) or moderate (50%-69%) luminal stenosis.
2.Age between 18 and 70 years. 3.Asymptomatic during exercise or recovery phases of cardiopulmonary assessment, including absence of angina, ST-segment depression, or complex arrhythmias at rest or during exercise.
4.Normal troponin levels. 5.Provided signed informed consent.
Exclusion Criteria:
1. Severe coronary artery stenosis. 2.Presence of severe respiratory or cardiovascular diseases (e.g., acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis).
3.Angina symptoms or signs during low-intensity exercise (<5 METs) or recovery. 4.Complex arrhythmias at rest or during exercise. 5.Hemodynamic abnormalities during exercise (e.g., failure of systolic blood pressure or heart rate to increase, or a decrease in blood pressure with increased exercise workload).
6.Severe psychological disorders. 7.Left ventricular ejection fraction (LVEF) < 40%. 8.Elevated troponin levels. 9.Inability to undergo cardiopulmonary exercise testing due to neuromuscular or musculoskeletal disorders.
10.Presence of other severe comorbidities. 11.Refusal to sign informed consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Experimental Group
Participants receiving the home-based cardiac rehabilitation program via a mobile application.
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The intervention is a comprehensive, personalized cardiac rehabilitation program delivered via a mobile health (mHealth) platform.
It consists of three core components: (1) Exercise Prescription: Personalized training plans aiming for 150 minutes of moderate-intensity aerobic exercise per week, combined with strength and flexibility training.
(2) Nutritional Guidance: An initial offline nutritional assessment and personalized meal planning, followed by monthly online follow-ups and adjustments.
(3) Psychological Support: Motivational interviewing and targeted psychological interventions provided as needed.
Additionally, the program utilizes the mHealth platform to provide weekly online community supervision, progress tracking, and continuous health education to enhance patient compliance and engagement.
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Ingen indgriben: Control Group
Participants receiving usual care and general health education
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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chang in non-calcified plaque volume
Tidsramme: Baseline and 12 months
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The change in non-calcified plaque volume will be assessed and quantified using Coronary Computed Tomography Angiography (CCTA).
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Baseline and 12 months
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2022-GSP-TS-5
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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