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

Physical Therapy for In-patients With Severe Anorexia Nervosa: A Randomized Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Center for Eating Disorders, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
No Intervention: Control; The control group follows ordinary treatment in consisting of re-nutrition and somatic stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to overall inpatient treatment.	Percentage obtained pre-defined goal weight (0-100%)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip strength	Grip strength is measured by a hand-held dynamometer. It measures the maximum grip strength force displayed in kilograms.	Change from baseline to follow-up (4 weeks)
Functional Movement	For assessment of functional movement is the Sit Up Stand Up test (SUSS) used. The test evaluates two functions 1)sit up from supine and 2)squatting form standing position. A score form 0-3 is given (0=poor, 2=intermedium, 3=good).	Change from baseline to follow-up (4 weeks)
Quality of Life	For assessment of quality of life is the Eating Disorder Quality of Life (EDQoL) questionnaire used. EDQLS is a disease-specific quality of life questionnaire developed for use in eating disorders. It consists of 40 items across 12 domains. In each domain patients respond on a 5-point likert scale (strongly agress through strongly disagree). Each domain has three questions, except the eating domain which consists of six questions. The domains are: school/work, family and close relationships, relationships with others, future, feelings, appearance, leisure, values and beliefs, cognitive, physical health, psychological health and eating. Each score is summed using a scoring algorithm with a higher total score indicating higher quality of life (0-200).	Change from baseline to follow-up (4 weeks)
Body Image	Eating Disorder Inventory (EDI) -3 Danish version is a self-reported assessment with 11 sub-scales, where only one sub-scale is used: body dissatisfaction with 9 items. Answers are given on a 6-point likert scale (highest body dissatisfaction = 6). Total range for the sub-scale: minimum=0 and maximum = 54.	Change from baseline to follow-up (4 weeks)
Body Mass Index	body weight (kg)/height (m)*height (m)	Change from baseline to follow-up (4 weeks)

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: René K Støving, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: PTSAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No