Training Intervention in the Treatment of Anorexia Nervosa

NCT ID: NCT04185727

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-05
• Study Completion Date: 2020-07-01

Brief Summary

The scope of the STRONG_2 project is to investigate the effect of supervised exercise as add-on to standard of care (SOC), for patients with eating disorders (EDs). The effect of supervised strength training will be measured on health parameters such as muscle strength. The study includes patients diagnosed with anorexia nervosa and in treatment at the Mental Health Center Ballerup (PCB) in the Capital Region of Denmark.

Detailed Description

Eating disorders (EDs) are the most common psychiatric disorder affecting young women and contribute with serious psychological, social, physical health complications, and a high mortality rate.

The first general treatment goal of EDs is to address medical complications and suicide risk, and then pathological health effects of the EDs such as bingeing and vomiting. Thereafter, the aim is to address ED psychopathology and behaviors via different forms of psychotherapy. Medical treatment is also used to treat comorbidities.

Treatment of EDs using standard of care (SOC) often implies a reduction in physical activity, and exercise is often prohibited during the intense phase of weight restoration. Since many patients for lengthy periods of time use excessive exercise as a way of compensatory behavior for calorie intake, the sudden stop in physical activity may trigger anxiety and lack of compliance during the weight restoration program. In addition, many ED patients have osteopenia, reduced muscle mass and show signed of depressiveness, all of which benefits from physical activity.

In order to change unhealthy exercise in patients with eating disorders, it may be beneficial to experience exercise in a novel way as part of the treatment for EDs. The number of studies describing supervised exercise for patients with EDs are few, especially for studies examining the effects of implementing exercise in the treatment of EDs in a Danish context. The National Clinical Guidelines suggest that supervised physical activity should be considered in the weight gaining phase as a supplement for common treatment for patients with anorexia nervosa (AN), although there is no description of how this intervention should be implemented (Sundhedsstyrelsen 2005). Knowledge concerning patients' pathological use of training and how this could be managed during rehabilitation is inadequate.

The STRONG_2 project will compare the effects of supervised strength training as add on to standard of care (SOC) vs. SOC alone, in patients with EDs at the Mental Health Center Ballerup (PCB) in the Capital Region of Denmark. Training effects on health parameters including muscle strength, eating disorder psychopathology and pathological exercise will be explored.

The STRONG_2 study will enable an increased understanding of the effects of supervised strength training on muscle strength, increase in muscle mass, and improved bone health, metabolism as well as ED psychopathology.

Conditions

Anorexia Nervosa; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care (SOC)

Therapy control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Standard of Care (SOC) + strength training

Strength training intervention as add on to therapy

Group Type: EXPERIMENTAL

Supervised strength training

Intervention Type: OTHER

12 weeks supervised strength training exposure. The study will allocate patients to groups consisting of 4 members who receive strength training for 12 weeks. The strength training program will consist of three weekly supervised strength exercise sessions, each 40-60 min of duration, which starts with a 10 min warm-up and are completed with a meditation/relax session.

Interventions

Supervised strength training

12 weeks supervised strength training exposure. The study will allocate patients to groups consisting of 4 members who receive strength training for 12 weeks. The strength training program will consist of three weekly supervised strength exercise sessions, each 40-60 min of duration, which starts with a 10 min warm-up and are completed with a meditation/relax session.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with AN according to the International Classification of Disorders version 10 (ICD-10)

2. Age 18-35

3. BMI > 14.5

4. Signed informed consent form-

Exclusion Criteria

1. Forced care

2. Unstable medical or psychiatric health

3. Issues with compliance to treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

University of South-Eastern Norway

OTHER

Sponsor Role: collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Magnus Sjögren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Eating disorder unit, Mental Health Services in the Capital Region, Ballerup

Louise B Rasmussen, MD, PhD

Role: STUDY_CHAIR

Mental Health Services in the Capital Region, Ballerup

Locations

Eating disorder unit, Mental Health Center

Ballerup Municipality, Danmark, Denmark

Institut for Idræt og Ernæring, NEXS, University of Copenhagen

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-19037864

Identifier Type: -

Identifier Source: org_study_id