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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06299254
Other study ID # 21C305
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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