Reliability and Validity of Physical Performance Tests in Individuals With Obesity

May 21, 2026 updated by: Yunus Emre Tutuneken

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

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

55

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Individuals With Obesity

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour
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.
1 hour
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.
1 hour
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.
1 hour
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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour
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
1 hour
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.
1 hour
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 20, 2026

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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