NCT05005832

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

15 days

First QC Date

July 23, 2021

Last Update Submit

October 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Tiffeneau-Pinelli index

    14-21 days

  • Clarke angle

    14-21 days

  • Transepidermal water loss

    14-21 days

Study Arms (1)

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.

Other: multi day walking

Interventions

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

People participating in the walking pilgrimage

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • women and men aged 18-65
  • BMI (body mass index) at the level of 18-39

You may not qualify if:

  • Chronic diseases Musculoskeletal injuries Mental disorders Surgery or hospitalization in the last year before the start of the study Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Biała Podlaska, 21-500, Poland

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHealth BehaviorFoot InjuriesDiseaseSkin Diseases

Condition Hierarchy (Ancestors)

BehaviorLeg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2021

First Posted

August 16, 2021

Study Start

August 16, 2021

Primary Completion

August 31, 2021

Study Completion

September 1, 2021

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations