Cardiovascular DiseasesNCT05005832
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.
An observational study of Cardiovascular Diseases and Health Behavior, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Diseases, Health Behavior, Foot Injuries and Disorders
- What is being tested?
- multi day walking
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 16 Aug 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- women and men aged 18-65
- BMI (body mass index) at the level of 18-39
Who cannot join
- Chronic diseases Musculoskeletal injuries Mental disorders Surgery or hospitalization in the last year before the start of the study Pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
Biała Podlaska, 21-500
About this study
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
- Being tested
- multi day walking
- Medical subject headings
- Cardiovascular Diseases, Health Behavior, Foot Injuries, Disease, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi day walkingOther
Over the course of 14 days, the pilgrims will cover a distance of about 300 km.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: multi day walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14-21 days
Secondary outcomes (3)
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%
Measured: 14-21 days
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)
Measured: 14-21 days
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).
Measured: 14-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start16 Aug 2021
- Primary completion31 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Szczepan Wiecha, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005832
- Sponsor's protocol ID
- SKE 01-25/2021
- Status last verified
- Oct 2021
- First submitted
- 23 Jul 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05005832
- Acronym / sponsor ID
- SKE 01-25/2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People participating in the walking pilgrimage | – | Other: multi day walkingPeople 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- women and men aged 18-65
- BMI (body mass index) at the level of 18-39
Key exclusion criteria (1 listed)
- Chronic diseases Musculoskeletal injuries Mental disorders Surgery or hospitalization in the last year before the start of the study Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi day walkingOver the course of 14 days, the pilgrims will cover a distance of about 300 km. | Other | People participating in the walking pilgrimage |
Primary outcome
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
3 secondary outcomes
Tiffeneau-Pinelli index
Time frame: 14-21 days
Clarke angle
Time frame: 14-21 days
Transepidermal water loss
Time frame: 14-21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Health Behavior, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systematic Coronary Risk Evaluation (time frame: 14-21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.