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Connect2Move: Valorization of Natural Cardio Trekking Hiking Trails (Connect2Move)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05226806
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : February 7, 2022
Sponsor:
Collaborators:
Ludwig Boltzmann Institute for Digital Health and Prevention
Paracelsus Medical University
Salzburg Research Forschungsgesellschaft mbH
Klinik St. Irmingard - Fachklinik für Onkologie, Kardiologie, Psychosomatik und Psychotraumatologie
Information provided by (Responsible Party):
Technical University of Munich ( Technische Universität München )

Brief Summary:

Regular exercise improves performance and reduces the risk of cardiovascular disease. Endurance and strength training are therefore forms of therapy with a high level of evidence in the prevention and rehabilitation of cardiovascular diseases. In this context, Hiking has a special role, as endurance exercise not only has a cardio-preventive effect, but also other health-promoting effects can be achieved through exercise in nature. However, intense physical activity can also trigger cardiovascular events, especially in poorly trained people. Hiking shows a particularly high rate of cardiovascular events including death. In addition to the incorrect assessment of the cardiovascular risk profile and physical performance, weather conditions (temperature, wind, precipitation) are often not included in the planning, which in combination further increases the risk of accidents. Hikers are rarely aware of the increased risk and prevent it through preventive medical examinations. Heart health can be assessed through a stress test or ergometry and at the same time endurance performance can be determined in the laboratory and training recommendations can be given based on the results. In order to use hiking specifically to prevent cardiovascular diseases and to reduce the risk of hiking accidents, this study sets the following goals:

  1. Development, validation and dissemination of a standardized 1km cardio trekking test trail to record the individual physical endurance performance (= cardio profile), with the aim of personal categorization / determination of the stress intensities when walking and hiking on medium-sized hiking trails and alpine pastures .
  2. Scientific conception and mapping of individual cardio profile standard routes through application-based data evaluation (digital cardio profile app) of the cardio trekking test trail for hiking tours in the partner regions Werfenweng and Aschau im Chiemgau.

The implementation of these goals should not replace the medical preventive examination, but serve as an additional prevention method.


Condition or disease Intervention/treatment
Cardiovascular Prevention Healthy Healthy Lifestyle Other: Measurement of cardiorespiratory performance in 3 different settings Other: GENERAL CARDIO HIKES AS PART OF GENERAL TOURIST OFFER OF MUNICIPALITIES

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Study Type : Observational
Estimated Enrollment : 144 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Connect2Move: Valorization of Natural Cardio Trekking Hiking Trails Through Open Innovation for the Sustainable Promotion of Health-oriented Tourism Across Generations
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : June 30, 2022

Group/Cohort Intervention/treatment
Healthy adults

Inclusion criteria: both, mals and female, age 45 years and older. Exclusion criteria: Medical contraindications for a maximum stress test and endurance test by the attending physician

Pathologies in the context of the preliminary examinations:

  • Acute and chronic cardiovascular diseases except arterial hypertension (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg in untreated and drug-treated participants) and minor valve insufficiency
  • Acute and chronic lung diseases
  • Liver and kidney diseases
  • diabetes mellitus
  • Alcohol (> 30g / day) or drug abuse
  • Obesity from grade 2 (body mass index> 35 kg / m²)
  • Orthopedic diseases with reduced physical performance
  • Existing pregnancy
Other: Measurement of cardiorespiratory performance in 3 different settings

The study is divided into three examinations days, which extend over a maximum of 2 weeks:

  • Day 1: Inclusion examination, time required: 1.5 hours Taking anamnesis, medical examination and blood drawing, determination of PROCAM score, Framingham score, ESC score, anthropometric measurements, questionnaires (IPAQ-physical activity, health status / quality of life (SF 36)), pulmonary function test, resting ECG, echocardiography, heart rate variability measurement (VO2max determination), spiroergometry (modified Bruce protocol) on the treadmill incl. inquiries about the BORG scale
  • Day 2: 1 km test trail, Time required: 1 hour: Completion of a 1 km cardio test path including mobile spiroergometry
  • Day 3: 8 km hike, time required approx. 3.5 hours: Participation in a guided cardio hike over 8 km, if applicable, including spiroergometry Afterwards (In Austria only): Logging of physical activity, physical motivation and accompanying circumstances over a period of 3 weeks

Other: GENERAL CARDIO HIKES AS PART OF GENERAL TOURIST OFFER OF MUNICIPALITIES
General cardio hikes (WITHOUT spirometric breathing gas analysis) on the selected hiking trails. Measurement of the heart rate as well as the route, time and walking speed using GPS geotracking using an anonymized user profile. User survey regarding the user-friendliness of the application.




Primary Outcome Measures :
  1. Development, validation and dissemination of a standardized 1 km Cardio-Trekking-Test Trail to record the individual physical endurance capacity [ Time Frame: 2 days ]

    The primary research aim is to answer the following research question:

    Development, validation and dissemination of a standardized 1 km Cardio-Trekking-Test Trail to record the individual physical endurance capacity (= CardioProfil), with the aim of personal categorization / determination of the stress intensities when walking and hiking on medium-sized hiking trails and alpine pastures



Secondary Outcome Measures :
  1. Scientific conception and mapping of cardio profile standard routes through application-based data evaluation (digital cardio profile application) of the cardio trekking test trails [ Time Frame: 1 day ]
    Scientific conception and mapping of cardio profile standard routes through application-based data evaluation (digital cardio profile application) of the cardio trekking test trails for hiking routes in the partner regions Werfenweng and Aschau im Chiemgau. Tourist, sports science and medical aspects (TUM, St. Irmingard Klinik Prien, LBI and all partners and regions) such as visitor frequency, degree of difficulty, sights and cultural heritage are also included as selection criteria.


Biospecimen Retention:   Samples Without DNA
Whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy adults
Criteria

Inclusion Criteria:

  • healthy adults

Exclusion Criteria:

  • Medical contraindications for a maximum stress test and endurance test by the attending physician

Pathologies in the context of the preliminary examinations:

  • Acute and chronic cardiovascular diseases except arterial hypertension (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg in untreated and drug-treated participants) and minor valve insufficiency
  • Acute and chronic lung diseases
  • Liver and kidney diseases
  • diabetes mellitus
  • Alcohol (> 30g / day) or drug abuse
  • Obesity from grade 2 (body mass index> 35 kg / m²)
  • Orthopedic diseases with reduced physical performance
  • Existing pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05226806


Contacts
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Contact: Birgit Böhm, PhD +49.89.289.24576 birgit.boehm@tum.de
Contact: Renate Oberhoffer-Fritz, MD +49.289.24571 info.gesundheit@tum.de

Locations
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Germany
Technical University of Munich Recruiting
Munich, Bavaria, Germany, 80992
Contact: Birgit Böhm, PhD    +49.89.289.24576    birgit.boehm@tum.de   
Principal Investigator: Birgit Böhm, PhD         
Sponsors and Collaborators
Technische Universität München
Ludwig Boltzmann Institute for Digital Health and Prevention
Paracelsus Medical University
Salzburg Research Forschungsgesellschaft mbH
Klinik St. Irmingard - Fachklinik für Onkologie, Kardiologie, Psychosomatik und Psychotraumatologie
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT05226806    
Other Study ID Numbers: 527/20 S
AB296 ( Other Grant/Funding Number: INTERREG Bavaria-Austria 2014-2020, EU Regional Development )
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Technical University of Munich ( Technische Universität München ):
Cardioresipratory fitness
Hiking
Cardiovascular prevention
Exercise
Outdoor sports