Condition category
Mental and Behavioural Disorders
Date applied
05/01/2015
Date assigned
26/01/2015
Last edited
26/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
About 30–40% of patients with eating disorders (anorexia nervosa or bulimia nervosa) over exercise. Excessive exercising is associated with a worsening of eating disorders. However, in some patients physical activity helps to reduce body dissatisfaction and eating disorder symptoms. Only a few programmes have been developed that specifically address or use physical activity in eating disorders. How eating disorders and physical exercise affect each other is not sufficiently understood. Our aim is to assess the effects of an exercise-therapy programme on patients with eating disorders. Also, we aim to investigate the relation between physical activity and eating disorders.

Who can participate?
Patients with eating disorders and a body-mass index greater than 16 kg/m² who exercise too much

What does the study involve?
Patients will be randomly allocated to a newly developed manualised sport-therapy programme or a waiting list control group. Patients in the sport-therapy programme will have one introductory meeting and 12 weekly group sessions. Each session will last 120 minutes and will start with a short exchange about how everyone feels, followed by a warm-up and an introduction to the topic of the week (educational component). The main part (45–60 minutes) contains physical activity and sport plays. The session closes with a reflection round and the prescription of homework, depending on the topic. The educational component of the programme focuses on healthy and unhealthy aspects of physical activity.
Patients in the intervention group will be assessed before the start of the intervention, 3 months later, at 6 months after the end of intervention. Patients in the waiting list control group will be assessed before the start of the intervention and 3 months later.

What are the possible benefits and risks of participating?
The benefits are reductions in body dissatisfaction and eating disorder symptoms

Where is the study run from?
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center (Germany)

When is the study starting and how long is it expected to run for?
From March 2015 to August 2017

Who is funding the study?
Schweizerische Anorexia nervosa Stiftung (Switzerland)

Who is the main contact?
Professor Almut Zeeck
almut.zeeck@uniklinik-freiburg.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof. Dr. Almut Zeeck

ORCID ID

Contact details

Hauptstrasse 8
Department of Psychosomatic Medicine and Psychotherapy
Freiburg
79104
Germany
+49/761/270-68420
almut.zeeck@uniklinik-freiburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37-14

Study information

Scientific title

Effects of the Freiburg sport-therapy programme on patients with eating disorders: a randomised study

Acronym

Study hypothesis

1. Pathological attitudes towards physical activity and pathological sport behavior will be significantly more reduced with the Freiburg sport-therapy intervention than spontaneous reductions in a control group (at the end of the intervention and at 6-months' follow-up)
2. Overall eating disorder will be significantly more reduced with the sport therapy intervention than spontaneous reductions or reductions with additional psychotherapy in the control group (at the end of the intervention and at 6-months' follow-up)

Ethics approval

Ethics committee of the University of Freiburg/Germany, 18 February 2013, number 65/13

Study design

Interventional, randomised controlled study at a single centre.

Primary study design

Interventional

Secondary study design

Add-on study: observational, ecological, momentary assessment

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Outpatients with eating disorders (anorexia nervosa, bulimia nervosa; body-mass index >16 kg/m² to < 25 kg/m²) and unhealthy exercise behaviour.

Intervention

A newly developed manualised sport-therapy programme (13-weekly group sessions; see Schlegel, et al, Psychother Psychosom Med Psychol 2012; http://cirrie.buffalo.edu/database/169270/) will be compared with a waiting list control group.

Patients will have one introductory meeting and 12 weekly group sessions. Each session will last 120 minutes and will start with a short exchange about how everyone feels, followed by a warm-up and an introduction to the topic of the week (educational component). The main part (45–60 minutes) contains physical activity and sport plays. The session closes with a reflection round and the prescription of homework, depending on the topic. The programme consists of five modules:
1. Module A is on becoming acquainted with the group
2. Module B is on education, self-monitoring and fostering the perception of one’s own body
3. Module C is on working on changing attitudes towards sports and sports behaviour (e.g., focusing on achievement orientation, perception of boundaries, reflecting aims related to exercising, balancing effort and recovery)
4. Module D focuses on playful and new experiences with different types of sports (especially team sports like volleyball or sports with a social component like dancing)
5. Module E is on a final reflection on the group experiences and plans for the future.

The educational component of the programme focuses on healthy and unhealthy aspects of physical activity.

Patients in the intervention group will have measurements done before the start of the intervention, 3 months later (at the end of the intervention), at 6 months after the end of intervention (follow-up).
The waiting list control group will be assessed before the start of the intervention and 3 months later.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Reduction in pathological exercising (Commitment to Exercise Scale total score)

Secondary outcome measures

Reduction in overall eating disorder (total Score Eating Disorder Examination)

Overall trial start date

01/03/2015

Overall trial end date

31/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Outpatients with a diagnosis of anorexia nervosa (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
2. Outpatients with a diagnosis of bulimia nervosa (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
3. Age at least 18 years old
4. Commitment to Exercise Scale total score >100
5. Body-mass index greater than 16 kg/m²

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Professional athletes
2. People waiting for an inpatient admission
3. Psychosis, substance dependency or organic brain disease
4. Patients with physical problems that do not allow them to participate in physical activities

Recruitment start date

01/03/2015

Recruitment end date

01/08/2016

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Psychosomatic Medicine and Psychotherapy, University Medical Center
Hauptstrasse 8
Freiburg
79104
Germany

Sponsor information

Organisation

University Medical Center Freiburg

Sponsor details

Hauptstrasse 8
Freiburg
79104
Germany

Sponsor type

Hospital/treatment centre

Website

www.uniklinik-freiburg.de

Funders

Funder type

Not defined

Funder name

Schweizerische Anorexia nervosa Stiftung, Switzerland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes