Physical Therapy for In-patients With Severe Anorexia Nervosa

NCT ID: NCT03472391

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-05-01

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: BEHAVIORAL

A 4-week (2 exercise session af week, of 40 minutes )tailored physiotherapeutic exercise program. The sessions are individually and supervised by physical therapist and tailored to patients with severe anorexia nervosa. The exercise program mainly consist of strength training exercises without any equipment other than a floor mat.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Therapy

A 4-week (2 exercise session af week, of 40 minutes )tailored physiotherapeutic exercise program. The sessions are individually and supervised by physical therapist and tailored to patients with severe anorexia nervosa. The exercise program mainly consist of strength training exercises without any equipment other than a floor mat.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

René Klinkby Støving

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

René K Støving

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Center for eating Disorders, Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

PTSAN

Identifier Type: -

Identifier Source: org_study_id