Study Results
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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COMPLETED
NA
37 participants
INTERVENTIONAL
2012-02-29
2013-11-30
Brief Summary
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Detailed Description
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This Guided Exercise (GEx-)- System consists of a easy to wear- vest with integrated electrodes to measure ECG, respiration and activity, furthermore of a PDA mobile phone with a touch screen for interaction with the patient and a patient station as interface between the personal digital assistant(PDA) and the professional station able to synchronize exercise plans prescribed by professionals and extract the monitored data from the PDA and upload it to the professional system using an internet connection.
Both intervention and control group undergo a baseline evaluation and an end evaluation including tests of the clinical routine like cardiopulmonary test (CPX), echocardiography and lactate measurement. They will also answer questionnaires referring to quality of life and the use of the system. During the training phase at home the interventional group will test the supervised training system during endurance training such as running, biking or walking and during resistance training such as performing exercise with rubber bands (at least 3x a week for about 5 months according to the generated prescription plan during training at the hospital). They will report their daily activity by diary. The control group will only report their physical activities by diary without using the Gex- System. At the end data are investigated to determine the feasibility to determine possible improvement obtained in long-term adherence to home- based rehabilitation programs when following a guided exercise training prescription supervised by the GEx- System.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Device Guided Exercise
Both intervention and control group undergo a baseline evaluation and an end evaluation including tests of the clinical routine like cardiopulmonary test (CPX), echocardiography and lactate measurement. They will also answer questionnaires referring to quality of life and the use of the system. During the training phase at home the interventional group will test the supervised training system during endurance training such as running, biking or walking and during resistance training such as performing exercise with rubber bands (at least 3x a week for about 5-6 months according to the generated prescription plan during training at the hospital). They will report their daily activity by diary. The control group will only report their physical activities by diary without using the Gex- System. At the end data are investigated to determine whether the supervised training with the GEx- System will improve the physical capacities of patients.
Guide Exercise (GEx-)- Training
Both intervention and control group undergo a baseline evaluation and an end evaluation including tests of the clinical routine like cardiopulmonary test (CPX), echocardiography and lactate measurement. They will also answer questionnaires referring to quality of life and the use of the system. During the training phase at home the interventional group will test the supervised training system during endurance training such as running, biking or walking and during resistance training such as performing exercise with rubber bands (at least 3x a week for about 5-6 months according to the generated prescription plan during training at the hospital). They will report their daily activity by diary. The control group will only report their physical activities by diary without using the Gex- System. At the end data are investigated to determine whether the supervised training with the GEx- System will improve the physical capacities ( VO2 peak) of patients.
Guided Exercise Training with an easy to wear vest with electrodes to measure ECG, respiration, activity
Control group training without Guided Exercise system at home
Interventions
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Guide Exercise (GEx-)- Training
Both intervention and control group undergo a baseline evaluation and an end evaluation including tests of the clinical routine like cardiopulmonary test (CPX), echocardiography and lactate measurement. They will also answer questionnaires referring to quality of life and the use of the system. During the training phase at home the interventional group will test the supervised training system during endurance training such as running, biking or walking and during resistance training such as performing exercise with rubber bands (at least 3x a week for about 5-6 months according to the generated prescription plan during training at the hospital). They will report their daily activity by diary. The control group will only report their physical activities by diary without using the Gex- System. At the end data are investigated to determine whether the supervised training with the GEx- System will improve the physical capacities ( VO2 peak) of patients.
Guided Exercise Training with an easy to wear vest with electrodes to measure ECG, respiration, activity
Control group training without Guided Exercise system at home
Eligibility Criteria
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Inclusion Criteria
* EF \> 30%
* patients willing to exercise
* with a preference for walking / running / cycling
* patients eligible for the normal local rehabilitation programs
* ability to use computer and internet
* adults who are contractually capable and mentally able to understand and follow the instructions of study personnel
* signed informed consent
Exclusion Criteria
* slow healing wounds
* pregnancy and breast feeding
18 Years
90 Years
ALL
No
Sponsors
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Hospital Universitario La Paz
OTHER
Hull University Teaching Hospitals NHS Trust
OTHER_GOV
Cardiac and Pulmonary Rehabilitation Clinic An der Rosenquelle
UNKNOWN
Universitat Politècnica de València
OTHER
Medtronic
INDUSTRY
Centre Suisse d'Electronique et de Microtechnique SA Switzerland
UNKNOWN
German Sport University, Cologne
OTHER
RWTH Aachen University
OTHER
Responsible Party
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Locations
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Universtiy Hospital of Aachen, Department of Cardiology
Aachen, Northrhine-Westfalia, Germany
Countries
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Other Identifiers
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11-020
Identifier Type: -
Identifier Source: org_study_id