NCT01906320

Brief Summary

The aim is to test the hypothesis that high-resistance training for 8 weeks, following the recommendations for healthy adolescents, is capable of eliciting increases in muscle strength, agility, skeletal muscle mass, and functional capacity without losing weight, body mass index (BMI) or fat mass in anorexia nervosa restricting type patients. Further, we hypothesize that the effects produced by the high-resistance training program will be maintained 4 weeks following the completion of the training program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

3.4 years

First QC Date

July 17, 2013

Last Update Submit

December 28, 2020

Conditions

Keywords

anorexia nervosarestricting typemuscle strengthexercisebody compositionphysical activity

Outcome Measures

Primary Outcomes (4)

  • Changes in Muscular Strength

    Muscular strength was assessed in the upper and lower body following a standardized strength testing protocol in the same resistance weight machines used in training sessions. The weightlifting training machines that were specifically built for the body size of children and adolescents (Strive Inc, PA, US) were used to carry out the 6RM (maximum repetitions) measured in Kilograms (kg). The lower body strength was assessed with seated leg-press, and upper body strength was assessed with seated bench press and seated lateral row

    3 times (week 0, week 8, week 12)

  • Changes in Agility

    To measure agility, we used the Time Up and Go (TUG) 3m and 10 m tests, and the Timed Up and Down Stairs (TUDS). These tests are reliable and validated for healthy children and adolescents, and used with other chronic pathologies such as cancer.

    3 times (week 0, week 8, week 12)

  • Changes in Body Composition - Anthropometry

    Body composition was obtained by collecting weight (kg) and height (m), and BMI was calculated as kg/m2. To obtain the % Fat Mass Heyward (2004) equation (specific for anorexia nervosa patients) was used. The skeletal muscle mass (SMM) was calculated using Poortmans (2005) equation. Fat Free Mass, and Fat mass where calculated based on Heyward and Poortmas equations. Skinfolds, diameters and perimeters where measured following the International Society for the advancement of the Kinanthropometry (ISAK) guidelines.

    3 times (week 0, week 8, week 12)

  • Functional Capacity

    Functional capacity was assessed by a graded exercise test on a treadmill in conjunction with an ECG response, and under similar environmental conditions. Treadmill speed began at 3.0 km/h with a grade of 5.0%; both were increased by 0.3 km/h and 0.5% respectively every 30s. The test was terminated upon volitional fatigue of the patient or when they showed loss of ability to maintain the required workload.VO2peak was determined as the higher value obtained after a period of 20s. Ventilatory Threshold (VT) was determined using the O2 equivalent (VE∙VO2-1) and O2 end-tidal pressure (PetO2) without increases in the CO2 equivalent (VE∙VCO2-1).

    3 times (week 0, week 8, week 12)

Secondary Outcomes (2)

  • Changes in Spontaneous Physical Activity habits - Accelerometry

    2 times (week 0, week 8)

  • Changes in perceived health-related QoL

    2 times (week 0, week 8)

Study Arms (2)

Training group

EXPERIMENTAL
Behavioral: High-Intensity Resistance training

Control Group

NO INTERVENTION

Interventions

Intervention group performed 3 weekly sessions during 8 weeks in the intra-hospital gymnasium. Each session lasted 50-60 min, and started and ended with warm-up and cool-down periods (10-15 min). The core session included bench press, leg press, lateral row, leg extension, lateral pull-down, abdominal crunch, low back extension, and push-ups exercises. The participants performed three sets of 8-10 repetitions with resting periods of 1-2 min on the weightlifting machines. Load was gradually increased 5-10 % as the participant strength was adapted. The load started at 70% of 6RM. Functional exercises (abdominal crunch, low back extension, and push-ups) were performed at the end of the session to strengthen the core musculature consisting of 3 sets of 15s of isometric contractions at the beginning of the program and 30 s at the end. Dynamic contractions were added, starting with 10 repetitions at the beginning to 30 repetitions at the end of the program.

Training group

Eligibility Criteria

Age12 Years - 16 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosed with anorexia nervosa restricting type
  • age ≤16 years
  • receiving psychological therapy 3 days/week, and daily life tracing (including diet)
  • BMI \>14.0 kg/m2

You may not qualify if:

  • being excessive exercisers (6 hours per week moderate to vigorous physical activity \[1952 counts/min\] upon admission)
  • not being able to perform physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad Europea

Villaviciosa de Odón, Madrid, 28670, Spain

Location

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Anorexia NervosaMotor Activity

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Assitant Professor

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 24, 2013

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

December 30, 2020

Record last verified: 2020-12

Locations