NCT05226806

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

January 26, 2022

Last Update Submit

January 8, 2025

Conditions

Keywords

Cardioresipratory fitnessHikingCardiovascular preventionExerciseOutdoor sports

Outcome Measures

Primary Outcomes (1)

  • Development, validation and dissemination of a standardized 1 km Cardio-Trekking-Test Trail to record the individual physical endurance capacity

    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

    2 days

Secondary Outcomes (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

    1 day

Study Arms (1)

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 settingsOther: GENERAL CARDIO HIKES AS PART OF GENERAL TOURIST OFFER OF MUNICIPALITIES

Interventions

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

Healthy adults

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.

Healthy adults

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adults

You may qualify if:

  • healthy adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University of Munich

Munich, Bavaria, 80992, Germany

Location

Related Publications (2)

  • Eisenberger L, Mayr B, Beck M, Venek V, Kranzinger C, Menzl A, Jahn I, Sareban M, Oberhoffer-Fritz R, Niebauer J, Bohm B. Assessment of Exercise Intensity for Uphill Walking in Healthy Adults Performed Indoors and Outdoors. Int J Environ Res Public Health. 2022 Dec 12;19(24):16662. doi: 10.3390/ijerph192416662.

  • Mayr B, Beck M, Eisenberger L, Venek V, Kranzinger C, Menzl A, Reich B, Hornung-Prahauser V, Oberhoffer-Fritz R, Bohm B, Niebauer J. Valorization of Natural Cardio Trekking Trails Through Open Innovation for the Promotion of Sustainable Cross-generational Health-Oriented Tourism in the Connect2Move Project: Protocol for a Cross-sectional Study. JMIR Res Protoc. 2022 Jul 13;11(7):e39038. doi: 10.2196/39038.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 7, 2022

Study Start

August 1, 2020

Primary Completion

April 30, 2022

Study Completion

June 30, 2022

Last Updated

January 9, 2025

Record last verified: 2022-01

Locations