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OpenTrials
Completed

NCT Number: 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.

The aim of the study is to assess the health habits and changes in body composition and exercise capacity as well as blood biochemical parameters of people participating in 14-21-day walking pilgrimages. This type of physical activity can be classified as long-term and multi-stage hiking tours. Among the people participating in the pilgrimage, a significant part of the population are people aged> 50 years. Moderate physical activity is an important pro-health element, however, it has not been determined yet how long and accumulated activity may affect the health of pilgrims. Suddenly taking up activity and the challenge of walking several hundred kilometres may be a heavy burden for the body, and its effects may have a negative impact on the body. The evaluation of the processes taking place in the body under the influence of this type of physical activity, motivated by religious goals, will expand the scope of knowledge about safety as well as health indications and contraindications for this type of activity. It will also allow identifying adaptive changes and their effects

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska

Biała Podlaska, 21-500, Poland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multi day walking

Other

Over the course of 14 days, the pilgrims will cover a distance of about 300 km.

Primary outcomes

  1. 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 (%),

    • Low- to moderate-risk persons (calculated SCORE <5%)
    • High-risk persons (calculated SCORE >5% and <10%):
    • Very-high-risk persons (calculated SCORE >10%):

    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

Secondary outcomes

  1. Tiffeneau-Pinelli index

    Time frame: 14-21 days

    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%

  2. Clarke angle

    Time frame: 14-21 days

    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)

  3. Transepidermal water loss

    Time frame: 14-21 days

    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).

Sponsors and collaborators

Lead sponsor

Józef Piłsudski University of Physical Education

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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