Anorexia NervosaPTSANNCT03472391
Physical Therapy for In-patients With Severe Anorexia Nervosa
A study testing Physical Therapy in people with Anorexia Nervosa, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for eating Disorders, Odense University Hospital
Odense, 5000
About this study
Official title: 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.
Read the 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
- Being tested
- Physical Therapy
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical Therapy |
| Control | No intervention | The control group follows ordinary treatment in consisting of re-nutrition and somatic stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to overall inpatient treatment.
Percentage obtained pre-defined goal weight (0-100%)
Measured: 4 weeks
Secondary outcomes (5)
Grip strength
Grip strength is measured by a hand-held dynamometer. It measures the maximum grip strength force displayed in kilograms.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Change from baseline to follow-up (4 weeks)
Body Mass Index
body weight (kg)/height (m)*height (m)
Measured: Change from baseline to follow-up (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Oct 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, René Klinkby Støving, Odense University Hospital
- Investigators
- René K Støving, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472391
- Sponsor's protocol ID
- PTSAN
- Acronym
- PTSAN
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy for In-patients With Severe Anorexia Nervosa: A Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT03472391
- Acronym / sponsor ID
- PTSAN / PTSAN
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Physical TherapySupervised 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. |
| Control | No intervention | –The control group follows ordinary treatment in consisting of re-nutrition and somatic stabilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyA 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. | Behavioural | Intervention |
Primary outcome
Compliance to overall inpatient treatment.
Time frame: 4 weeks
Percentage obtained pre-defined goal weight (0-100%)
5 secondary outcomes
Grip strength
Time frame: Change from baseline to follow-up (4 weeks)
Functional Movement
Time frame: Change from baseline to follow-up (4 weeks)
Quality of Life
Time frame: Change from baseline to follow-up (4 weeks)
Body Image
Time frame: Change from baseline to follow-up (4 weeks)
Body Mass Index
Time frame: Change from baseline to follow-up (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René K Støving principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Anorexia Nervosa, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to overall inpatient treatment. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.