Physical Therapy for In-patients With Severe Anorexia Nervosa (PTSAN)

Odense University Hospital

Status: Completed

Conditions: Anorexia Nervosa

Treatments: Behavioral: Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03472391

PTSAN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intervention

Active Comparator group

Description:

Supervised exercise therapy by physical therapist: patients allocated to physical therapy will participate in a 4-week (2 sessions a week of 40 minutes) supervised and tailored exercise program mainly consisting of light strength training. The exercise program is an add-on treatment to the primary treatment of re-nutrition and somatic stabilization.

Treatment:

Behavioral: Physical Therapy

Control

No Intervention group

Description:

The control group follows ordinary treatment in consisting of re-nutrition and somatic stabilization