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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00829946
Other study ID # R-0034/08
Secondary ID
Status Completed
Phase N/A
First received January 26, 2009
Last updated January 26, 2009
Start date January 2008
Est. completion date March 2008

Study information

Verified date January 2009
Source Universidad Europea de Madrid
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

A total of 22 outpatients [20 female (Tanner stage II-IV), 2 male (Tanner stage IV); age range: 12-16 years] were finally eligible and thus participated in the study.

Participants in the intervention group were enrolled in two training sessions per week for 12 weeks. Each session lasted 60-70 min and started at ~11:30 a.m., after the intra-hospital psychotherapy session. The program was individually supervised, i.e. one instructor for every three patients.

Each session started and ended with a low intensity 10-15min warm-up and cool-down period respectively, consisting of stretching exercises involving all major muscle groups. 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. Stretching exercises of the muscles involved in the previous exercises were performed during the rest periods (21).

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.

Outcome measures:

- Anthopometry

- Cardiorespiratory fitness

- Muscular strength

- Functional mobility

- Quality of life


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date March 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Female
Age group N/A to 16 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical activity
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Universidad Europea de Madrid Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life Yes
Primary Anthropometry Yes
Primary Functional mobility Yes
Secondary Muscular strength Yes
Secondary Cardiorespiratory fitness Yes
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