- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560153
Interest of Karate Kata Practice on the Self-esteem of Patients Living With HIV (KATACHRO)
Since ancient times, physical and sports activity has been recognized as bringing many health benefits. Descriptive and interventional studies on physical activity are developing, demonstrating physical and psychological benefits for patients with various diseases.
Physical activity is effective in improving self-esteem in the general population. Good self-esteem allows for better autonomy to manage a chronic illness.
The benefit of physical activity in patients living with HIV has been the subject of several studies, notably outside France, and seems to improve the quality of life.
We hypothesize that sport, especially karate kata, could improve self-esteem in patients living with HIV, and represent another non-drug aid, in patients living with HIV.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Le Mans, France, 72000
- Centre Hospitalier du Mans
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patient living with HIV
- Patient seen in the infectious diseases department of Le Mans hospital, during a consultation or day hospitalization for HIV follow-up
- Aged 18 years and older
- Patients able to understand and to give informed consent to participate in the study
- valid social security coverage
- written and signed informed consent by the patient and investigator
Exclusion Criteria:
- refusal to participate to the study
- pregnant or brest-feeding women
- person subject to a legal protection measure
- patient with psychiatric disease
- patient under legal protection
- medical contraindication to play karate kata
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patient living with HIV
|
sessions of karate kata every week during 4 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of karate kata training on self-esteem among patients living with HIV followed at the Le Mans hospital center
Time Frame: 4 months
|
Change from Baseline at 4 months as assessed by Rosenberg's questionnaire
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHM-2019/S10/05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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