- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
1-Minute Stair Climbing Test
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cardiopulmonary Exercise Testing (VO₂max)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 21
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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