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.

October 20, 2021 updated by: Szczepan Wiecha, Józef Piłsudski University of Physical Education
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

Study Overview

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Biała Podlaska, Poland, 21-500
        • Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People taking part in a walking pilgrimage from Biała Podlaska to Częstochowa (Poland) over a distance of approximately 350 kilometres and a duration of approximately 14 days in August 2021

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Over the course of 14 days, the pilgrims will cover a distance of about 300 km.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

14-21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%

14-21 days
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)
14-21 days
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).

14-21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2021

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • SKE 01-25/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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