Training Intervention in the Treatment of Anorexia Nervosa

NCT04185727 | Terminated DMC

• 1 other identifier: H-19037864
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Anorexia Nervosa; Exercise

Keywords

feeding and eating disorders; training; supervised exercise; muscle strength; anorexia nervosa; bone health; psychopathology; pathophysiology; intervention; prospective

Outcome Measures

Primary Outcomes (3)

• Maximal strength leg press

  Difference in muscle strength measured with leg press strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Strength test measurement tool is leg press measured with 1 repetition maximum (1RM) in Kilograms (kg).

  Base line, week 6, week 12

• Maximal strength bench press

  Difference in muscle strength measured with bench press strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Strength test measurement tool is bench press measured with 1 repetition maximum (1RM) in Kilograms (kg).

  Base line, week 6, week 12

• Maximal strength pull down

  Difference in muscle strength measured with pull down strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training. Strength test measurement tool is pull down measured with 1 repetition maximum (1RM) in Kilograms (kg).

  Base line, week 6, week 12

Secondary Outcomes (27)

• EDI-DT subscale score

  Baseline, week 6, week 12, week 24

• EDI subscale score

  Baseline, week 6, week 12, week 24

• Changes in Eating Disorder Symptoms

  Baseline, week 12, week 24

• VAS-mood

  Baseline, week 1, week 6, week 12, week 24

• Anxiety (HAM-A-6)

  Baseline, week 6, week 12, week 24

Study Arms (2)

Standard of Care (SOC)

NO INTERVENTION

Therapy control group

Standard of Care (SOC) + strength training

EXPERIMENTAL

Strength training intervention as add on to therapy

Other: Supervised strength training

Interventions

Supervised strength training 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.

Standard of Care (SOC) + strength training

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with AN according to the International Classification of Disorders version 10 (ICD-10)
• Age 18-35
• BMI \> 14.5
• Signed informed consent form-

You may not qualify if:

• Forced care
• Unstable medical or psychiatric health
• Issues with compliance to treatment

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• University of Copenhagen: collaborator
• University of South-Eastern Norway: collaborator

Study Sites (2)

Eating disorder unit, Mental Health Center

Ballerup Municipality, Danmark, 2750, Denmark

Location

Institut for Idræt og Ernæring, NEXS, University of Copenhagen

Copenhagen, 2200 and 1958, Denmark

Location

MeSH Terms

Conditions

Anorexia Nervosa; Motor Activity; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Magnus Sjögren, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Louise B Rasmussen, MD, PhD

  Mental Health Services in the Capital Region, Ballerup

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized controlled open trial, comparing the effect of Standard of care (SOC) with Standard of care + strength training. The interventional clinical trial design includes two parallel groups and 12 weeks exposure. The goal is to include 24-30 patients. The study will allocate patients to groups consisting of 4 members who receive either SOC or SOC + strength training for 12 weeks. All participants are assessed at baseline, after 1 week, after 6 weeks, post-treatment (12 weeks), and at 6 months' post follow-up (24 weeks) and monitored for changes in physiological, biological and psychological variables. Some tests are also done more frequently. 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.

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 4, 2019
• Study Start: December 5, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 26, 2021

Record last verified: 2019-11

Locations

DK (2)