NCT00829946

Brief Summary

The purpose of the present randomized controlled trial was to determine the effects of a 3-month resistance training program (2 sessions/week) on the functional mobility and muscle function, muscular dynamic strength, body composition and quality of life of young anorexic outpatients (≤16 years). The investigators also assessed cardiorespiratory variables of clinical significance such as peak oxygen uptake.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
Last Updated

January 27, 2009

Status Verified

January 1, 2009

Enrollment Period

Same day

First QC Date

January 26, 2009

Last Update Submit

January 26, 2009

Conditions

Keywords

Strength trainingAnorexiaGirlsQuality of lifeFunctional mobility

Outcome Measures

Primary Outcomes (3)

  • Quality of life

  • Anthropometry

  • Functional mobility

Secondary Outcomes (2)

  • Muscular strength

  • Cardiorespiratory fitness

Study Arms (1)

2

EXPERIMENTAL
Behavioral: Physical activity

Interventions

Participants in the intervention group were enrolled in two training sessions per week for 12 weeks. The core portion of the training session consisted of 11 strength exercises engaging the major muscle groups, i.e. bench press, shoulder press, leg extension, leg press, leg curl, abdominal crunch, low back extension, arm curl, elbow extension, seated row and lateral pull-down. For each exercise, the participants performed one set of 8-15 repetitions (total of \~ 20s duration) with resting periods of 1-2 min between exercises. The load was gradually increased as the strength of each child improved, i.e. from 20-30% of 6 repetition maximum (6RM) at the start of the program to 50-60% of 6RM at the end. Participants also performed isometric contractions of large muscle groups (6 sets of 3 repetitions each, 20-30s duration per repetition) with their own body weight (for lower body exercises) or barbells (1-3kg) for upper body.

2

Eligibility Criteria

AgeUp to 16 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of restrictive anorexia nervosa
  • Age ≤ 16 years
  • Undergoing intra-hospital psychotherapy and dietary counseling (two visits per week) in this Hospital
  • Body mass index \> 14.0 kg/m2

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anorexia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

January 27, 2009

Record last verified: 2009-01