Placebo Effect About Fatigue in Obesity

Obesity Clinical Trial

— POF  

Official title:

The Modulation of Individual Level of Fatigue Through Placebo Effect in Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299254
• Other study ID #: 21C305
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Federica Scarpina, PhD
• Phone: +39032351
• Email: f.scarpina[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2025
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion criteria:

• Right-handed diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders

Related Conditions & MeSH terms

• Fatigue
• Obesity

Intervention

Other:
• Placebo-Natural History
Half of the participants will receive a placebo (i.e., motivational/verbal) cue before and after an experimental session in which they will perform several lifts. Half of the participants will receive no placebo before and after an experimental session in which they will perform several lifts.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe	Piancavallo	VCO

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioural outcome of fatigue	The number of flexions (from a minimum of 0 to maximum of180) performed before and after the treatment for each individual.	baseline
Secondary	The individual level of perceived fatigue	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.	baseline