NCT02142439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

5.9 years

First QC Date

February 27, 2014

Last Update Submit

March 25, 2020

Conditions

Keywords

AnorexiaBulimiaPhysical activityTreatment

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density (DXA)

    up to two years follow-up

Secondary Outcomes (8)

  • 1RM squats

    16 weeks, two years follow-up

  • 1RM bench press

    16 weeks, two years follow-up

  • Eating Disorders Examination clinical interview

    16 weeks, two years follow-up

  • DXA

    16 weeks, two years follow-up

  • Self-reported physical activity behavior

    16 weeks, two years follow-up

  • +3 more secondary outcomes

Other Outcomes (3)

  • Body attitude

    16 weeks, two years follow-up

  • Short Form - 36

    16 weeks, two years follow-up

  • Participants' experience with strength training

    16 weeks

Study Arms (4)

Intervention group 1

EXPERIMENTAL

Exercise counseling 1 time/week, Strength training 3 times/week, dose: 5 RM x 3 sets.

Behavioral: Strength training

Intervention group 2

EXPERIMENTAL

Exercise counseling 1 time/week. Strength training 3 times/week, dose: 10 RM x 3 sets.

Behavioral: Strength training

Intervention group 3

EXPERIMENTAL

Exercise counseling 1 time/week. Strength training 3 times/week, dose: 30 RM x 3 sets

Behavioral: Strength training

Control group

NO INTERVENTION

Exercise counseling 1 time/week

Interventions

Three times per week with strength training

Intervention group 1Intervention group 2Intervention group 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Agder

Kristiansand, Agder, Norway

Location

Telemark University College

Bø, Telemark, 3800, Norway

Location

Norwegian school of sport sciences

Oslo, Norway

Location

Related Publications (7)

  • 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.

    PMID: 16637047BACKGROUND
  • 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.

    PMID: 21360368BACKGROUND
  • 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.

    PMID: 11085841BACKGROUND
  • 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.

    PMID: 16138787BACKGROUND
  • 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.

    PMID: 23287836BACKGROUND
  • 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.

    PMID: 12588057BACKGROUND
  • 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.

    PMID: 16874594BACKGROUND

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexiaBulimiaMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHyperphagiaBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Solfrid Bratland-Sanda, PhD

    University of South-Eastern Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

May 20, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

No IPD will be made available to other researchers

Locations