- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05005832
Influence of Walking Pilgrimage on Changes in Body Composition, Biochemical Parameters, Circulatory and Respiratory Efficiency and Foot Biomechanics in Healthy Women and Men of All Ages.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Biała Podlaska, Poland, 21-500
- Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
women and men aged 18-65
BMI (body mass index) at the level of 18-39
Exclusion Criteria:
Chronic diseases Musculoskeletal injuries Mental disorders Surgery or hospitalization in the last year before the start of the study Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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People participating in the walking pilgrimage
People taking part in the study will be healthy people without any existing systemic diseases and musculoskeletal injuries, and will not engage in professional physical activity.
The age of the respondents will be in the range of 18-65 years and BMI in the range of 18-39.
People who have valid medical examinations will be admitted to the tests, with no contraindications to physical activity.
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Over the course of 14 days, the pilgrims will cover a distance of about 300 km.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Systematic Coronary Risk Evaluation
Time Frame: 14-21 days
|
Systematic Coronary Risk Evaluation scales (SCORE) are high and low cardiovascular risk charts based on gender, age, total cholesterol, systolic blood pressure and smoking status, with relative risk chart, qualifiers and instructions. SCORE calculate 10-year risk of fatal cardiovascular disease (%),
Charts are available free at https://www.escardio.org/Education/Practice-Tools/CVD-prevention-toolbox/SCORE-Risk-Charts Risk estimation using SCORE: https://www.heartscore.org/en_GB/access-heartscore-quick-calculator |
14-21 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tiffeneau-Pinelli index
Time Frame: 14-21 days
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Tiffeneau-Pinelli index FEV1/FVC% The FEV1/FVC ratio, also called Tiffeneau-Pinelli index, is a calculated ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).The result of this ratio is expressed as FEV1%. Normal FEV1% values are approximately 70-80% |
14-21 days
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Clarke angle
Time Frame: 14-21 days
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The Clarke angle (CL)enables the assessment of the longitudinal arch of the foot.
Feet having a CL angle value of less than 42° are classified as the feet with the fallen arch, i.e., the flatfoot (pes planus), feet classified as having a proper (normal) arch are characterised by the CL restricted within the range of 42-54° (pes rectus), whereas feet having CL ≥ 55° are classified as feet with a high arch (pes cavus)
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14-21 days
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Transepidermal water loss
Time Frame: 14-21 days
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Transepidermal water loss (TEWL) is the most widely used objective measurement for assessing the barrier function of skin in healthy individuals. TEWL is the quantity of condensed water that diffuses across a fixed area of stratum corneum to the skin surface per unit time. TEWL are stated as grams of water per square meter per hour (g/m2/h). Measured at forehead and right cheek. TEWL normal values (mean,95% CI) for forehead 12.8 (11.7-14.0) and cheek 13.9 (12.9-14.9). |
14-21 days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKE 01-25/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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