Evaluation of Physical Fitness and Hemodynamics Across a Diverse Population

NCT06669715 | Recruiting

• 3 other identifiers: ACT-ON802-15/2023-5005-1/2023
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, investigators will use the IFT 30-15 test, a six-minute walking test, and a treadmill test to assess the participants' cardiorespiratory fitness. For the treadmill cardiopulmonary exercise test (CPET), we will measure indirect gas exchange using a CPET device (K5). Maximum heart rate (HRmax) will be measured with a Polar heart rate monitor (model H10). The six-minute walking test will follow standardized procedures, and the treadmill test will follow a protocol of gradually increasing speed each minute. The study will involve two groups of participants: healthy individuals and pre-hypertensive individuals. While the IFT 30-15 test has been validated on a diverse range of athletes and physically active individuals, it has not yet been validated in individuals with similar characteristics to our participants (BMI \> 30 and limited cardiovascular function). Additionally, a variety of hemodynamic measures and other physical function measures such as sit-to-stand and push-ups will be assessed for all participants.

Conditions

Prehypertension (elevated Blood Pressure) or Hypertension; Obesity and Obesity-related Medical Conditions

Keywords

cardiovascular fitness; CRF; physical fitness testing; vascular function; heamodynamics; blood pressure; prehypertension; aerobic capacity; arterial stiffness; endothelial function; post-occlusive reactive hyperemia; PORH

Outcome Measures

Primary Outcomes (3)

• Aerobic capacity (Vo2max-CPET)

  Aerobic capacity will be assessed using cardiopulmonary exercise test on a treadmill. Unit of measure (ml/kg/min)

  Baseline

• Aerobic capacity (Vo2max-IFT)

  Aerobic capacity will be assessed using 30-15 intermittent fitness test. Unit of measure Vo2max derived from the maximal running velocity at the final stage of the test (ml/kg/min)

  Baseline

• Aerobic capacity (Vo2max-6MWT)

  Aerobic capacity will be assessed using 6-minute walk test. Unit of measure - Vo2max derived from the maximal walking distance achieved on the text (ml/kg/min)

  Baseline

Secondary Outcomes (4)

• Stiffness of brachial artery

  Baseline

• Flow-mediated slowing (FMS) of brachial artery

  Baseline

• Brachial artery pulse wave analysis

  Baseline

• Carotid - femoral (cfPWV) arterial stiffness

  Baseline

Other Outcomes (2)

• Sit-to-stand performance

  Baseline

• Push-ups

  Baseline

Study Arms (2)

Asymptomatic individuals - apparently healthy

Asymptomatic individuals - apparently healthy

Symptomatic individuals

Symptomatic individuals - prehypertensive and hypertensive individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to recruit adults (18 + years of age), without restrictions on sex, health status, or physical fitness level.

You may qualify if:

• Adults (18 + years of age) without restriction on sex, health status or physical fitness.

You may not qualify if:

• Inability to walk without assistance
• Presence of acute injuries and/or illnesses that limit maximal exertion during physical fitness testing
• Lower extremity injury or surgery within the past 2 years (if not fully rehabilitated)

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

Faculty of Sport, University of Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Prehypertension; Hypertension; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Armin Paravlic, PhD

  Faculty of Sport, University of Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armin H Researcher, PhD

CONTACT

+386015207840; armin.paravlic@fsp.uni-lj.si

Kristina Drole, MSc

CONTACT

Kristina.Drole@fsp.uni-lj.si

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

SL (1)