- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07605793
Reliability and Validity of Physical Performance Tests in Individuals With Obesity
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.
연구 개요
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
1-Minute Stair Climbing Test
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cardiopulmonary Exercise Testing (VO₂max)
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .