Skip to main content
OpenTrials
Completed

NCT Number: NCT03472391

Physical Therapy for In-patients With Severe Anorexia Nervosa

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for eating Disorders, Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Compliance to overall inpatient treatment.

    Time frame: 4 weeks

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

Secondary outcomes

  1. Grip strength

    Time frame: Change from baseline to follow-up (4 weeks)

    Grip strength is measured by a hand-held dynamometer. It measures the maximum grip strength force displayed in kilograms.

  2. Functional Movement

    Time frame: Change from baseline to follow-up (4 weeks)

    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).

  3. Quality of Life

    Time frame: Change from baseline to follow-up (4 weeks)

    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).

  4. Body Image

    Time frame: Change from baseline to follow-up (4 weeks)

    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.

  5. Body Mass Index

    Time frame: Change from baseline to follow-up (4 weeks)

    body weight (kg)/height (m)*height (m)

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

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

Acronym: PTSAN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2018
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.