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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Center for eating Disorders, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm 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.

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

Outcomes

Primary Outcome Measures

Compliance to overall inpatient treatment.
Percentage obtained pre-defined goal weight (0-100%)

Secondary Outcome Measures

Grip strength
Grip strength is measured by a hand-held dynamometer. It measures the maximum grip strength force displayed in kilograms.
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).
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).
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.
Body Mass Index
body weight (kg)/height (m)*height (m)

Full Information

First Posted
March 6, 2018
Last Updated
March 19, 2019
Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03472391
Brief Title
Physical Therapy for In-patients With Severe Anorexia Nervosa
Acronym
PTSAN
Official Title
Physical Therapy for In-patients With Severe Anorexia Nervosa: A Randomized Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group follows ordinary treatment in consisting of re-nutrition and somatic stabilization
Intervention Type
Behavioral
Intervention Name(s)
Physical Therapy
Intervention Description
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 Outcome Measure Information:
Title
Compliance to overall inpatient treatment.
Description
Percentage obtained pre-defined goal weight (0-100%)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Grip strength
Description
Grip strength is measured by a hand-held dynamometer. It measures the maximum grip strength force displayed in kilograms.
Time Frame
Change from baseline to follow-up (4 weeks)
Title
Functional Movement
Description
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).
Time Frame
Change from baseline to follow-up (4 weeks)
Title
Quality of Life
Description
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).
Time Frame
Change from baseline to follow-up (4 weeks)
Title
Body Image
Description
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.
Time Frame
Change from baseline to follow-up (4 weeks)
Title
Body Mass Index
Description
body weight (kg)/height (m)*height (m)
Time Frame
Change from baseline to follow-up (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René K Støving
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for eating Disorders, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Therapy for In-patients With Severe Anorexia Nervosa

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