Placebo Effect About Fatigue in Obesity

Recruiting

• Conditions: Obesity
• Interventions: Other: Placebo-Natural History

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

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy-weight participants	Placebo-Natural History	As controls, not-hospitalized participants with a healthy weight
Participants with obesity	Placebo-Natural History	Participants affected by obesity (the level of body mass index (BMI) higher or equal to 30).

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