Clinical Trials Logo

Clinical Trial Summary

The primary objectives of the APAREXIM'Pilot study are to evaluate the short- and medium-term effects of a live supervised Adapted Physical Activity (APA) program via videoconferencing on: - Feasibility and acceptability of APA via videoconferencing by the patients. - The primary symptoms of Anorexia Nervosa (AN). The secondary objectives are to evaluate the impact of this program on : - Mental health - Physical condition - Sleep-wake cycle (sleep disturbance and physical hyperactivity) The patients will first undergo an inclusion visit (T0) at the University Hospital of Caen, then a first evaluation session (T1) at the COMETE laboratory in Caen (physical tests, questionnaires, sleep diary, actimetry). They will then be randomly divided into 2 groups: 15 patients who will follow an APA program supervised by videoconference for 8 weeks (AM-APA) at their home, in addition to the usual outpatient treatment, and 15 patients who will benefit only from the classic outpatient treatment (AM-T). All patients will undergo two additional evaluation sessions at one week post-program (T2) and at 3 months post-program (T3).


Clinical Trial Description

Background: Anorexia nervosa (AN) is an eating disorder (ED), mainly in women, characterized by strict and voluntary food deprivation over a long period of time, which can last from several months to several years, leading to significant weight loss. This disease affects 2.2 to 4% of the general population in Europe and is one of the most fatal psychiatric diseases in people under 25 years old. Physiological and psychological disorders are very often associated with AN, as well as an alteration of the sleep-wake cycle. In order to reduce the risk of chronicity of the disease and to prevent its various complications in young women, early and multidisciplinary therapeutic management is recommended by public health authorities. However, this management remains long and complex due to the diversity and severity of the symptoms, a lack of adherence of patients to treatment protocols, but also a lack of therapeutic continuity after hospitalization. Recently, new non-medicinal therapies based on Adapted Physical Activity (APA) have been developed to prevent and reduce the main symptoms of AN and associated disorders in an effective and lasting way. However, to our knowledge, interventional research in this field remains scarce and presents limited results. Furthermore, the scientific literature does not report any evaluation of the feasibility, acceptability, and effectiveness of a home video-conference-supervised APA intervention with AN patients. Objectives: The primary objectives of the APAREXIM'Pilot study are to evaluate the short- and medium-term effects of a live supervised APA program via videoconferencing on feasibility and acceptability of APA via videoconferencing by the patients and the primary symptoms of AN. The secondary objectives are to evaluate the impact of this program on mental health, physical condition and the sleep-wake cycle (sleep disturbance and physical hyperactivity), as well as its. Method: This randomized controlled intervention study will be conducted with 30 adolescent and young adult girls with AN. The patients will first undergo an inclusion visit (T0) at the University Hospital of Caen, then a first evaluation session (T1) at the COMETE laboratory in Caen (physical tests, questionnaires, sleep diary, actimetry). They will then be randomly divided into 2 groups: 15 patients who will follow an APA program supervised by videoconference for 8 weeks (AM-APA) at their home, in addition to the usual outpatient treatment, and 15 patients who will benefit only from the classic outpatient treatment (AM-T). All patients will undergo two additional evaluation sessions at one week post-program (T2) and at 3 months post-program (T3). Perspectives: The results obtained will allow to evaluate the acceptability and the feasibility of a distance APA program, and to bring additional evidence of the effectiveness of an APA intervention in patients with AM, as well as elements of understanding of the regulation of this pathology by APA. In addition, the APAREXIM'Pilot study will allow to test and validate an APA program for patients with AM, which could eventually be integrated in the management of patients on the national territory. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05770089
Study type Interventional
Source University Hospital, Caen
Contact
Status Active, not recruiting
Phase N/A
Start date November 2, 2022
Completion date December 1, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05531604 - Appetitive Conditioning in Anorexia Nervosa
Enrolling by invitation NCT04174703 - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing N/A
Active, not recruiting NCT04883554 - Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study N/A
Recruiting NCT04213820 - TMS and Body Image Treatment for Anorexia Nervosa N/A
Completed NCT03414112 - The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa Early Phase 1
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Recruiting NCT05803707 - Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study N/A
Recruiting NCT05682417 - Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa N/A
Not yet recruiting NCT06380257 - Anorexia Nervosa and Brain in Adolescence
Not yet recruiting NCT04804800 - Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa N/A
Not yet recruiting NCT03600610 - Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa N/A
Completed NCT02745067 - Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa N/A
Completed NCT02382055 - Changing Habits in Anorexia Nervosa: Novel Treatment Development N/A
Completed NCT03075371 - Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa N/A
Terminated NCT02240797 - Kappa Opioid Receptor Imaging in Anorexia N/A
Completed NCT03144986 - Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa N/A
Unknown status NCT01761942 - Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa Phase 2
Completed NCT02551445 - A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders. N/A
Completed NCT01579682 - Adaptive Family Treatment for Adolescent Anorexia Nervosa N/A
Completed NCT00946816 - The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity N/A