Placebo Effect About Fatigue in Obesity

Completed

• Conditions: Obesity

• Registration Number: NCT06299254
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-07
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Behavioural outcome of fatigue	baseline	The number of flexions (from a minimum of 0 to maximum of180) performed before and after the treatment for each individual.

Secondary Outcome Measures

Name	Time	Method
The individual level of perceived fatigue	baseline	On a Likert scale (from 0 to 7), participants verbally report the individual level of perceived fatigue in doing the flexions before and after the treatment.

Trial Locations

Locations (1)

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe; 🇮🇹 Piancavallo, VCO, Italy