Reliability and Validity of Physical Performance Tests in Individuals With Obesity

NCT07605793 | Not Yet Recruiting

• 1 other identifier: 21
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity & Overweight

Keywords

Obesity; Performance test; Balance; Exercise capacity

Outcome Measures

Primary Outcomes (5)

• 1-Minute Stair Climbing Test

  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.

  1 hour

• 40-Meter Fast-Paced Walk Test

  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.

  1 hour

• 2-Minute Walk Test

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

  1 hour

• Timed Up and Go Test

  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.

  1 hour

• 30-Second Sit-to-Stand Test

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

  1 hour

Secondary Outcomes (4)

• Cardiopulmonary Exercise Testing (VO₂max)

  1 hour

• Static Balance Assessment

  1 hour

• Knee Extensor Muscle Strength

  1 hour

• Dynamic Balance Assessment

  1 hour

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals With Obesity

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yunus Emre Tutuneken: lead

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Istinye University

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 26, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05