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.

Cardiovascular Diseases Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005832
• Other study ID #: SKE 01-25/2021
• Status: Completed
• Start date: August 16, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2021
• Source: Józef Pilsudski University of Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2021
• Est. primary completion date: August 31, 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Foot Injuries
• Foot Injuries and Disorders
• Health Behavior
• Skin Condition
• Skin Diseases

Intervention

Other:
• multi day walking
Over the course of 14 days, the pilgrims will cover a distance of about 300 km.

Locations

Country	Name	City	State
Poland	Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska	Biala Podlaska

Sponsors (1)

Lead Sponsor	Collaborator
Józef Pilsudski University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systematic Coronary Risk Evaluation	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	14-21 days
Secondary	Tiffeneau-Pinelli index	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
Secondary	Clarke angle	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)	14-21 days
Secondary	Transepidermal water loss	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