Clinical trial NCT03472391: Physical Therapy for In-patients With Severe Anorexia Nervosa
Official title: Physical Therapy for In-patients With Severe Anorexia Nervosa: A Randomized Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2018-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In-patients with severe anorexia nervosa (AN) often drop out of treatment, because of ambivalence towards treatment and anxiety for weight gain. However, physical therapy has shown some positive effects on symptoms of AN. This study aims to investigate the feasibility of a randomized control trial (RCT) of a standardized physiotherapeutic program for patients with severe AN with compliance to nutritional therapy as the primary outcome measure.

Detailed description: Anorexia nervosa (AN) is a serious and complex disease with unknown etiology. It is characterised by disturbed body image and extreme and devastating fear of gaining weight. The illness leads to a considerable and sometimes dangerous weight loss because of the limited food intake and often an exaggerated exercise behavior. AN can affect people of all ages and of both sexes, but girls or young women are more at risk. The prevalence among young women in Denmark is estimated to be between 0.4% and 1%. AN is associated with a high rate of comorbidity and mortality.

The treatment of AN consist of re-feeding and psychotherapy. Different therapeutic methods and theories have been applied, but none have shown to be superior. The patient alliance and motivation for treatment seem to be essential for a successful treatment. Drop-out is a common challenge. Hence, attention must be directed to how the therapeutic alliance and the patient's motivation can be optimized in order to secure a better treatment effect.

Studies have shown that physical therapy, including supervised exercise and bodily focused interventions, may have a positive effect on symptoms of AN. It may reduce the distorted body image and anxiety. However, it is unknown whether physical therapy can affect compliance and drop out rate to the nutrition therapy. The objective of this study is to investigate the feasibility of a RCT design in this group of patients with severe AN at a specialized unit. The intervention is supervised, standardized physical therapeutic exercises mainly consisting of light strength training. The development of the intervention is based partly on the literature, and partly on interviews and observations with two patients with severe AN.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the specialized nutrition section at Odense University Hospital and are fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AN.
* 18 years of age or older
* Patients who can be included within the first two weeks of hospitalization

Exclusion Criteria:

* Patients who can not fill in a Danish-language questionnaire.
* Patients who are not able to be in standing position.
* Patients who are not respiratory and circulatory stable.

Primary outcomes:
measure: Compliance to overall inpatient treatment.
timeFrame: 4 weeks
Secondary outcomes:
measure: Grip strength
timeFrame: Change from baseline to follow-up (4 weeks)
measure: Functional Movement
timeFrame: Change from baseline to follow-up (4 weeks)
measure: Quality of Life
timeFrame: Change from baseline to follow-up (4 weeks)
measure: Body Image
timeFrame: Change from baseline to follow-up (4 weeks)
measure: Body Mass Index
timeFrame: Change from baseline to follow-up (4 weeks)
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Center for eating Disorders, Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: René K Støving
role: PRINCIPAL_INVESTIGATOR
References: