Placebo Effect About Fatigue in Obesity

NCT06299254 | Completed

• 1 other identifier: 21C305
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

placebo effect; fatigue; motivation; physical abilities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The individual level of perceived fatigue

  baseline

Study Arms (2)

Participants with obesity

Participants affected by obesity (the level of body mass index (BMI) higher or equal to 30).

Other: Placebo-Natural History

Healthy-weight participants

As controls, not-hospitalized participants with a healthy weight

Other: Placebo-Natural History

Interventions

Placebo-Natural History OTHER

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.

Healthy-weight participants; Participants with obesity

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• University of Turin, Italy: collaborator

Study Sites (1)

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

Location

MeSH Terms

Conditions

Obesity; Fatigue

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 7, 2024
• Study Start: March 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

IT (1)