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STERK - Strength Training and Eating Disorders

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ClinicalTrials.gov Identifier: NCT02142439
Recruitment Status : Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
University of Agder
Norwegian School of Sport Sciences
Modum Bad
Information provided by (Responsible Party):
Telemark University College

Brief Summary:
Strength training has been found effective for enhancement of bone health, muscle strength and body composition among premenopausal women from the general population, however it is unclear to what extend strength training might improve these parameters among women with eating disorders. The aim of this study is therefore to examine acute and long-term effects of strength training among persons with eating disorders. The study is a randomized, controlled, single-blinded trial with three intervention groups and one control group. The three intervention groups will perform different volumes of strength training. The intervention period is 16 weeks with three sessions per week. At pretest, posttest, and 6 months, 12 months and 24 months follow-up, the following variables will be measured: bone health, muscle strength, power, body composition hormone levels, physical activity level and compulsivity, body awareness, quality of life, and eating disorders psychopathology. Qualitative in-depth interviews will be carried out to explore the participants' experiences with strength training. The study is carried out in Norway, and is performed in collaboration with Telemark University College, University of Agder, Norwegian school of sport sciences and Modum Bad psychiatric center. The results from the study might implicate on strength training as part of treatment for eating disorders.

Condition or disease Intervention/treatment Phase
Eating Disorders Behavioral: Strength training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Strength Training and Eating Disorders (STERK - Styrketrening og Spiseforstyrrelser)
Study Start Date : January 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Intervention group 1
Exercise counseling 1 time/week, Strength training 3 times/week, dose: 5 RM x 3 sets.
Behavioral: Strength training
Three times per week with strength training

Experimental: Intervention group 2
Exercise counseling 1 time/week. Strength training 3 times/week, dose: 10 RM x 3 sets.
Behavioral: Strength training
Three times per week with strength training

Experimental: Intervention group 3
Exercise counseling 1 time/week. Strength training 3 times/week, dose: 30 RM x 3 sets
Behavioral: Strength training
Three times per week with strength training

No Intervention: Control group
Exercise counseling 1 time/week



Primary Outcome Measures :
  1. Bone mineral density (DXA) [ Time Frame: up to two years follow-up ]

Secondary Outcome Measures :
  1. 1RM squats [ Time Frame: 16 weeks, two years follow-up ]
    1 repetition maximum (RM) for lower extremities (squats) and upper extremities (bench press)

  2. 1RM bench press [ Time Frame: 16 weeks, two years follow-up ]
    1 repetition maximum (RM) for lower extremities (squats) and upper extremities (bench press)

  3. Eating Disorders Examination clinical interview [ Time Frame: 16 weeks, two years follow-up ]
    Clinical interview using Eating Disorders Examination Interview

  4. DXA [ Time Frame: 16 weeks, two years follow-up ]
    Measure body weight, and lean body mass and adipose tissue by DXA

  5. Self-reported physical activity behavior [ Time Frame: 16 weeks, two years follow-up ]
    Assess physical activity volume (duration, frequency and intensity) through exercise log Assess compulsivity through Compulsive Exercise Test

  6. symptom check list (SCL-90) [ Time Frame: 16 weeks, two years follow-up ]
    General psychopathology

  7. Hormone levels [ Time Frame: 16 weeks, two years follow-up ]
    Blood sample of Insuline Growth Factor (IGF-1), Thyroid stimulating hormone (TSH), T3, T4, leptine, cortisol, estradiol, progesterone, growth hormone (GH)

  8. blood levels [ Time Frame: 16 weeks, two years follow-up ]
    Calcium, vit D, sodium, potassium, magnesium, phosphate, blood sugar and cholesterol


Other Outcome Measures:
  1. Body attitude [ Time Frame: 16 weeks, two years follow-up ]
    Body Attitudes Test

  2. Short Form - 36 [ Time Frame: 16 weeks, two years follow-up ]
    Quality of life

  3. Participants' experience with strength training [ Time Frame: 16 weeks ]
    In-depth qualitative interview



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meeting diagnostic criteria for anorexia nervosa, bulimia nervosa or eating disorders not otherwise specified
  • Outpatient/home-dwelling
  • Age: 18 years or older
  • Premenopausal women

Exclusion Criteria:

  • BMI <15 kg/m2
  • Osteoporosis (t-score < -2,5 including low energy fracture)
  • Psychosis, suicidal behavior
  • Planned changes in medication during the 16 weeks of intervention
  • Planned pregnancy within the 16 weeks intervention period, and/or up to one year follow-up (due to DXA scanning)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142439


Locations
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Norway
University of Agder
Kristiansand, Agder, Norway
Telemark University College
Bø, Telemark, Norway, 3800
Norwegian school of sport sciences
Oslo, Norway
Sponsors and Collaborators
Telemark University College
University of Agder
Norwegian School of Sport Sciences
Modum Bad
Investigators
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Study Chair: Solfrid Bratland-Sanda, PhD Telemark University College

Publications:

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Responsible Party: Telemark University College
ClinicalTrials.gov Identifier: NCT02142439     History of Changes
Other Study ID Numbers: STERK
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be made available to other researchers

Keywords provided by Telemark University College:
Anorexia
Bulimia
Physical activity
Treatment

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders