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- Klinische proef NCT01250600
Effects of Intelligent Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction
Application of Intelligent Wireless and Portable Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction
Although a lot of evidence and guidelines recommend that patients have cardiac rehabilitation, in reality, the actual rate cardiac patients entering cardiac rehabilitation program is low, usually less than one third. One of the main hindrances of patients participating cardiac rehabilitation program is insufficient number of medical institutions that can provide rehabilitation services. Patients usually cannot perform exercise program under medical professionals monitoring without having to go far. This spatial and temporal difficulty led to the low rate of patients taking cardiac rehabilitation program. The risk of patients to do exercise is higher than healthy adult.
This project will develop the intelligent portable remote care system for cardiopulmonary exercise to provide an instant ECG monitoring service through the integration of front-end wireless ECG measuring devices, expert system, and back-end tele-care platform. Many patients are inconvenient to go to large hospital regularly for cardiac rehabilitation training. This project will help them to exercise at home after once or twice rehabilitation training in clinic for each month and the medical professional will supervise remotely to see how much exercise they did. For that reason the project can help to break through spatial and temporal difficulty of having cardiac rehabilitation, so that cardiac rehabilitation can be help more patients. Patients have this tele-care system while they are doing exercise at home, the built-in heart rate and cardiac rhythm warning function will remind them to take a break, even to take medical treatment. More importantly, the ECG signal can be almost immediately (real time) uploaded by network to the chest pain unit of hospital. The cardiology expert will be aware of the warning at the first moment. This is an important protection to patients' safety of doing rehabilitation sports at home.
This randomized control trial will recruit 80 patients who had myocardial infarction within 6 weeks, and are not able to attend a hospital based cardiac rehabilitation program regularly. All patient will undergo a three-month home exercise program under the instruction provided by the physiatrists and physiotherapists. Forty of them (the remote-care group) will use the intelligent portable remote care system for cardiopulmonary exercise to monitor their exercise intensity and cardiac rhythm during exercise. The other 40 patients (the control group) undertake the exercise program at home without using the remote care system. The efficacy and safety of exercise program will be compared between the two groups.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Nai-Hsin Meng, M.D.
- Telefoonnummer: 2380 886-4-22052121
- E-mail: nsmeng@ms13.hinet.net
Studie Locaties
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-
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Taichung, Taiwan, 404
- China Medical University Hospital
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Hoofdonderzoeker:
- Nai-Hsin Meng, M.D.
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Contact:
- Nai-Hsin Meng, M.D.
- Telefoonnummer: 2380 886-4-22052121
- E-mail: nsmeng@ms13.hinet.net
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Onderonderzoeker:
- Pei-Yu Yang, MD, Msc
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- within 6 weeks after an acute myocardial infarction
- not able to attend a hospital based cardiac rehabilitation program regularly
Exclusion Criteria:
- with left ventricular ejection fraction lower than 40%
- history of cardiac arrest
- history of cardiogenic shock, heart failure
- complicated arrhythmia
- abnormal exercise hemodynamics: blood pressure not increased with exercise
- any other physical/psychological condition that hinders the patient's walking ability
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Remote-care
Home exercise monitored by the remote care system
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Daily home exercise for 3 months
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Actieve vergelijker: Control
Home exercise under expert's instruction
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Daily home exercise for 3 months
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change from baseline in exercise capacity at 3 months
Tijdsspanne: baseline and after a 3-month exercise program
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6-minute walk test and maximum oxygen uptake obtained by a graded exercise test
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baseline and after a 3-month exercise program
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change from baseline in quality of life at 3 months.
Tijdsspanne: baseline and after a 3-month exercise program
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Quality of life questionnaires, including SF-36
|
baseline and after a 3-month exercise program
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Change from baseline in physical activities at 3 months.
Tijdsspanne: baseline and after a 3-month exercise program
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The International Physical Activity Questionnaire
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baseline and after a 3-month exercise program
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nai-Hsin Meng, M.D., China Medical University Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CMU99-NCTU-12
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