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Eating DisordersNCT02142439

STERK - Strength Training and Eating Disorders

A study testing Strength training in people with Eating Disorders, run by University of South-Eastern Norway at 3 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Eating Disorders
What is being tested?
Strength training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesNorway
Study dates
Jan 2014to Dec 2019
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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

3 sites in 1 country.

Norway3 sites
  • Telemark University College

    Bø, Telemark, 3800

  • University of Agder

    Kristiansand, Agder

  • Norwegian school of sport sciences

    Oslo

Other trials in Norway

About this study

Official title: Strength Training and Eating Disorders (STERK - Styrketrening og Spiseforstyrrelser)

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.

Read the detailed description

ED are mental disorders which often lead to serious medical complications such as hormone disturbances, osteopenia/osteoporosis, and myopathy. More than 90% of females with anorexia nervosa (AN) have osteopenia, and almost 40% have osteoporosis. Osteoporosis in the European Union is estimated to cost 37 billion euros each year, and the majority of persons with osteoporosis are untreated. Although economic analysis of osteoporosis in Norway is lacking, the prevalence of osteoporosis in Norway is among the world's highest.

Strength training is effective in treatment of osteoporosis among postmenopausal women. Despite this, evidence based knowledge about strength training as a possible treatment-option for osteopenia/osteoporosis in ED is lacking. Due to the long half-life of bisphosphonates, such medications must be used carefully among young adults. Hence, there are no current well-documented treatment strategies for osteopenia/osteoporosis for this age group.

Although excessive physical activity is a common symptom among persons with ED, strength training is an exercise modality rarely used in this population. In addition, restoration of body weight is an important treatment goal for underweight persons with ED. Such a weight restoration leads to altered body composition with higher increase in adipose tissue compared to lean tissue, and the adipose tissue often redistribute to more abdominal fat. Such altered body composition might increase risk of cardiovascular disease and increased body dissatisfaction, and hence increase risk of relapse.

Strength training affects body composition in persons both with and without ED. It is therefore interesting to examine if strength training intervention affects body dissatisfaction, and hence reduce psychopathology and increase quality of life, among persons suffering from ED.

Existing studies with strength training intervention use different repetitions, sets and intensities. Campos et al. found that few repetitions (i.e. 3-5 rep x 3 sets) were more effective in increasing muscle strength compared to medium (9-11 rep x 3) and many repetitions (20-28 rep x 2), while the latter gave largest increase in muscular endurance among healthy males. Mosti et al. found increased bone mass in lumbar spine and femur neck and alterations in blood bone markers after 12 weeks of strength training (3-5 reps x 4 sets, 85-90% of 1RM) among postmenopausal women with osteopenia/osteoporosis. A study using both low and high intensity strength training intervention lasting for 12 months found increased bone mineral density (BMD) in lumbar spine among healthy elderly women. The few existing studies using strength training among persons with ED have all used low intensity strength training, and none of these have examined the effects on bone health. Two randomized controlled trials found effect of strength training on body composition, muscle strength and quality of life among persons with Anorexia Nervosa, whereas Del Valle et al. only found effects on quality of life. The low intensity might explain the lack of effects in the latter study. It is therefore a need for studies using adequate dosage of strength training among persons with ED.

Strength training is a treatment method with few possible side effects. Such training might however lead to a drop in blood pressure, this is a possible side effect among persons with ED because hypotension is more prevalent in this population compared to the general population. Due to safety reasons, this aspect is important to map.

Approaches, hypotheses and choice of method

The following research questions problems (RQ) have been defined:

RQ 1: What is the effect of different strength training regimes on bone health among persons with ED? RQ 2: What is the effect of different strength training regimes on body composition, hormone levels, muscle strength and power among persons with ED? RQ 3: What is the effect of different strength training regimes on ED psychopathology, body awareness and quality of life among persons with ED? RQ 4: What is the effect of different strength training regimes on weekly physical activity, motives for physical activity and compulsive exercise among persons with ED? RQ 5: What is the immediate effect of different strength training regimes on blood pressure among persons with ED? RQ 6: How do persons with ED experience the use of strength training as part of treatment for ED? RQ 7: What is the long-term effect of different strength training regimes on bone health among persons with ED? RQ 8: What is the long-term effect of different strength training regimes on body composition, hormone levels, muscle strength and power among persons with ED? RQ 9: What is the long-term effect of different strength training regimes on ED psychopathology, body awareness and quality of life among persons with ED? RQ 10: What is the long-term effect of different strength training regimes on weekly physical activity, motives for physical activity and compulsive exercise among persons with ED?

To examine the research questions, we will use a multi-methods approach. We will conduct a randomized controlled trial with four groups (n=200), these groups will be followed during the 16 weeks intervention period and up to two years follow-up. We will use both quantitative objective and self-report assessment methods, and qualitative in-depth interviews. To answer RQ 1 and RQ 2, objective assessment methods such as dual x-ray absorptiometry (DXA), blood samples and strength tests using squats and bench press will be conducted. RQ 3 and RQ 4 are answered by using standardized self-report instruments. Ambulatory continuous blood pressure monitors will be used during the first strength training session to answer RQ 5. RQ 6 will be answered by selecting participants to be informants in a qualitative semi-structured in-depth interview. To answer RQ 7-10, follow-up 6 months, 12 months and 24 months after the intervention will be conducted. We have chosen a randomized controlled design because it is the gold standard when examining effects of different treatment interventions. However, we believe it is important to take the participants' experiences into account, because this can give valuable additional information about the clinical significance of the interventions. Such information is valuable when considering the use of strength training intervention in clinical settings in the future. In evidence-based practice, it is essential to considerate both clinical expertise, a wide research perspective and the patients' preferences and subjective experiences of needs. This justify the use of a multi-methods approach where both quantitative objective and qualitative data are included.

Bone health is promoted through regular weight-bearing physical activity that use muscular strength and power and exert force on the skeleton above normal amounts. This project will expand the knowledge about how strength training can be used as a component of treatment in ED. Strength training has several benefits for persons with and without ED, however the existing studies have not examined one of the most important parameters, i.e. bone health. This project therefore seeks to assess parameters which allow us to explore the effects of strength training in details. Furthermore, we will examine and take the participants' own experiences into account. This is important so that future treatment can design and adapt the exercises to each individual.

Being tested
Strength training
Keywords
Anorexia, Bulimia, Physical activity, Treatment
Medical subject headings
Feeding and Eating Disorders, Anorexia, Bulimia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strength trainingBehavioural

    Three times per week with strength training

Study groups in NCT02142439
Study groupRoleWhat they receive
Intervention group 1ExperimentalExercise counseling 1 time/week, Strength training 3 times/week, dose: 5 RM x 3 sets.
Receives: Behavioral: Strength training
Intervention group 2ExperimentalExercise counseling 1 time/week. Strength training 3 times/week, dose: 10 RM x 3 sets.
Receives: Behavioral: Strength training
Intervention group 3ExperimentalExercise counseling 1 time/week. Strength training 3 times/week, dose: 30 RM x 3 sets
Receives: Behavioral: Strength training
Control groupNo interventionExercise counseling 1 time/week

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone mineral density (DXA)

    Measured: up to two years follow-up

Secondary outcomes (8)
  1. 1RM squats

    1 repetition maximum (RM) for lower extremities (squats) and upper extremities (bench press)

    Measured: 16 weeks, two years follow-up

  2. 1RM bench press

    1 repetition maximum (RM) for lower extremities (squats) and upper extremities (bench press)

    Measured: 16 weeks, two years follow-up

  3. Eating Disorders Examination clinical interview

    Clinical interview using Eating Disorders Examination Interview

    Measured: 16 weeks, two years follow-up

  4. DXA

    Measure body weight, and lean body mass and adipose tissue by DXA

    Measured: 16 weeks, two years follow-up

  5. Self-reported physical activity behavior

    Assess physical activity volume (duration, frequency and intensity) through exercise log Assess compulsivity through Compulsive Exercise Test

    Measured: 16 weeks, two years follow-up

  6. symptom check list (SCL-90)

    General psychopathology

    Measured: 16 weeks, two years follow-up

  7. Hormone levels

    Blood sample of Insuline Growth Factor (IGF-1), Thyroid stimulating hormone (TSH), T3, T4, leptine, cortisol, estradiol, progesterone, growth hormone (GH)

    Measured: 16 weeks, two years follow-up

  8. blood levels

    Calcium, vit D, sodium, potassium, magnesium, phosphate, blood sugar and cholesterol

    Measured: 16 weeks, two years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

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
Single blind
Who is masked
Investigator
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02142439
Sponsor's protocol ID
STERK
Status last verified
Mar 2020
First submitted
27 Feb 2014
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No: No IPD will be made available to other researchers

Publications

  • Shroff H, Reba L, Thornton LM, Tozzi F, Klump KL, Berrettini WH, Brandt H, Crawford S, Crow S, Fichter MM, Goldman D, Halmi KA, Johnson C, Kaplan AS, Keel P, LaVia M, Mitchell J, Rotondo A, Strober M, Treasure J, Woodside DB, Kaye WH, Bulik CM. Features associated with excessive exercise in women with eating disorders. Int J Eat Disord. 2006 Sep;39(6):454-61. doi: 10.1002/eat.20247.

    PubMed 16637047
  • Mehler PS, Cleary BS, Gaudiani JL. Osteoporosis in anorexia nervosa. Eat Disord. 2011 Mar-Apr;19(2):194-202. doi: 10.1080/10640266.2011.551636.

    PubMed 21360368
  • Grinspoon S, Thomas E, Pitts S, Gross E, Mickley D, Miller K, Herzog D, Klibanski A. Prevalence and predictive factors for regional osteopenia in women with anorexia nervosa. Ann Intern Med. 2000 Nov 21;133(10):790-4. doi: 10.7326/0003-4819-133-10-200011210-00011.

    PubMed 11085841
  • Borer KT. Physical activity in the prevention and amelioration of osteoporosis in women : interaction of mechanical, hormonal and dietary factors. Sports Med. 2005;35(9):779-830. doi: 10.2165/00007256-200535090-00004.

    PubMed 16138787
  • Mosti MP, Kaehler N, Stunes AK, Hoff J, Syversen U. Maximal strength training in postmenopausal women with osteoporosis or osteopenia. J Strength Cond Res. 2013 Oct;27(10):2879-86. doi: 10.1519/JSC.0b013e318280d4e2.

    PubMed 23287836
  • Szabo CP, Green K. Hospitalized anorexics and resistance training: impact on body composition and psychological well-being. A preliminary study. Eat Weight Disord. 2002 Dec;7(4):293-7. doi: 10.1007/BF03324975.

    PubMed 12588057
  • Chantler I, Szabo CP, Green K. Muscular strength changes in hospitalized anorexic patients after an eight week resistance training program. Int J Sports Med. 2006 Aug;27(8):660-5. doi: 10.1055/s-2005-865812.

    PubMed 16874594

Questions about this trial

What is this clinical trial studying?

A study testing Strength training in people with Eating Disorders, run by University of South-Eastern Norway at 3 sites in Norway.

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 4 inclusion and 5 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. 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?

Bone mineral density (DXA) (time frame: up to two years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02142439, which also lists 7 linked publications.

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 26 Mar 2020.

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