Physical Therapy for In-patients With Severe Anorexia Nervosa

NCT03472391 | Completed

• 1 other identifier: PTSAN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• Compliance to overall inpatient treatment.

  Percentage obtained pre-defined goal weight (0-100%)

  4 weeks

Secondary Outcomes (5)

• Grip strength

  Change from baseline to follow-up (4 weeks)

• Functional Movement

  Change from baseline to follow-up (4 weeks)

• Quality of Life

  Change from baseline to follow-up (4 weeks)

• Body Image

  Change from baseline to follow-up (4 weeks)

• Body Mass Index

  Change from baseline to follow-up (4 weeks)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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.

Behavioral: Physical Therapy

Control

NO INTERVENTION

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

Interventions

Physical Therapy 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Center for eating Disorders, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• René K Støving

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 21, 2018
• Study Start: October 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)