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NCT Number: NCT07605793

Reliability and Validity of Physical Performance Tests in Individuals With Obesity

This study aims to investigate the reliability and validity of practical performance-based physical function tests in individuals with obesity. Functional limitations such as reduced walking ability, impaired balance, and decreased lower extremity strength are common in people with obesity and may negatively affect daily activities and quality of life.

Participants will complete several commonly used clinical functional tests, including the 1-Minute Stair Climbing Test, 40-Meter Fast-Paced Walk Test, 2-Minute Walk Test, Timed Up and Go Test, and 30-Second Sit-to-Stand Test. In addition, cardiopulmonary exercise testing, balance assessment, and knee extensor muscle strength measurements will be performed.

The study will evaluate whether these simple and clinically applicable tests provide reliable results over repeated measurements and whether they are associated with objective indicators of physical function such as maximal oxygen consumption (VO₂max), balance performance, and muscle strength. The findings may help clinicians use practical and cost-effective tools to assess physical function in individuals with obesity.

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) ≥ 30 kg/m²
  • Stable body weight during the last 3 months (less than ±2 kg change)
  • Ability to perform daily living activities independently

Exclusion criteria

  • History of cardiovascular disease
  • History of pulmonary disease
  • History of neurological disease
  • Musculoskeletal injury affecting lower extremity function
  • Presence of lower extremity prosthesis or severe deformity
  • Major surgery within the previous 6 months
  • Pregnancy
  • Postpartum period
  • Vestibular disorders affecting balance
  • Visual impairments affecting test performance
  • Hearing impairments affecting test performance
  • Cognitive impairment limiting understanding of instructions
  • Participation in strenuous physical activity before testing
  • Use of medications affecting cardiopulmonary responses (e.g., beta-blockers)

Treatment and study plan

physical performance tests

Other

Participants will undergo a series of standardized performance-based physical function assessments, including the 1-Minute Stair Climbing Test, 40-Meter Fast-Paced Walk Test, 2-Minute Walk Test, Timed Up and Go Test, and 30-Second Sit-to-Stand Test. Each test will be performed twice with standardized rest intervals between assessments. To evaluate test-retest reliability, the same functional tests will be repeated 5-7 days later under identical conditions and in the same order.

In addition to functional testing, participants will complete cardiopulmonary exercise testing (CPET) using the Modified Bruce Protocol to determine maximal oxygen consumption (VO₂max), computerized static and dynamic balance assessments using the PROKIN® system, and knee extensor muscle strength measurements using a hand-held dynamometer. No therapeutic intervention or treatment will be administered during the study.

Primary outcomes

  1. 1-Minute Stair Climbing Test

    Time frame: 1 hour

    A performance-based functional test used to assess stair climbing ability and lower extremity functional capacity. The total number of completed stair cycles within 1 minute will be recorded.

  2. 40-Meter Fast-Paced Walk Test

    Time frame: 1 hour

    A walking performance test used to evaluate fast-paced gait speed and functional mobility. The time required to complete a total walking distance of 40 meters will be measured in seconds.

  3. 2-Minute Walk Test

    Time frame: 1 hour

    A functional endurance test used to assess ambulatory capacity. The total walking distance completed within 2 minutes will be recorded in meters.

  4. Timed Up and Go Test

    Time frame: 1 hour

    A functional mobility test used to assess dynamic balance and independent mobility. The time required to stand up from a chair, walk 3 meters, return, and sit down will be measured in seconds.

  5. 30-Second Sit-to-Stand Test

    Time frame: 1 hour

    A lower extremity functional strength and endurance test. The total number of sit-to-stand repetitions completed within 30 seconds will be recorded.

Secondary outcomes

  1. Cardiopulmonary Exercise Testing (VO₂max)

    Time frame: 1 hour

    A maximal exercise test performed using the Modified Bruce Protocol on a treadmill to assess aerobic exercise capacity. Maximal oxygen consumption (VO₂max) values will be recorded.

  2. Static Balance Assessment

    Time frame: 1 hour

    Balance performance will be evaluated using the PROKIN® computerized balance assessment system. Parameters related to postural stability and body sway during static tasks will be recorded

  3. Knee Extensor Muscle Strength

    Time frame: 1 hour

    Isometric knee extensor muscle strength will be measured using a hand-held dynamometer. Maximum voluntary contraction force will be recorded.

  4. Dynamic Balance Assessment

    Time frame: 1 hour

    Description: Balance performance will be evaluated using the PROKIN® computerized balance assessment system. Parameters related to postural stability and body sway during static and dynamic tasks will be recorded

Sponsors and collaborators

Lead sponsor

Yunus Emre Tutuneken

Other

Registry information

Official study title

Clinician-Friendly Physical Performance Tests in Individuals With Obesity: Reliability and Validity

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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