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Effects of a High Intensity Resistance Training in Muscular Strength, Agility, and Body Composition of Anorexia Nervosa Restricting Type Patients

Primary Purpose

Anorexia Nervosa Restricting Type

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High-Intensity Resistance training
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa Restricting Type focused on measuring anorexia nervosa, restricting type, muscle strength, exercise, body composition, physical activity

Eligibility Criteria

12 Years - 16 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Universidad Europea
  • Hospital Infantil Universitario Niño Jesús

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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
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.
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.
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).

Secondary Outcome Measures

Changes in Spontaneous Physical Activity habits - Accelerometry
Patients were required to maintain their normal physical activity while they were using an uni-axial accelerometer (Actigraph MTI, GT1M model, Manufacturing Technology Inc., Fort Walton Beach, FL, USA). At least 7 days were recorded (Monday-Sunday) with a minimum of 10-hour registration per day was set as an inclusion criterion. The time sampling interval (epoch) was set at 15 seconds. Average physical activity intensity was expressed as (sum of counts registered per epoch)/(Total Time Registered) (cpm). Time spent in light, moderate, vigorous, very vigorous and moderate to vigorous physical activity (MVPA) was presented as means per day depending on the metabolic equivalents (MET). Time spent in low intensity physical activity or sedentary time was the total time registered minus the total time active. Time spent in moderate to vigorous physical activity was presented as means of minutes per day
Changes in perceived health-related QoL
Patients were requested to fill in the SF-36 questionnaire to assess their perceptions in physical and mental health-related QoL

Full Information

First Posted
July 17, 2013
Last Updated
December 28, 2020
Sponsor
Universidad Europea de Madrid
Collaborators
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT01906320
Brief Title
Effects of a High Intensity Resistance Training in Muscular Strength, Agility, and Body Composition of Anorexia Nervosa Restricting Type Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid
Collaborators
Hospital Infantil Universitario Niño Jesús, Madrid, Spain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa Restricting Type
Keywords
anorexia nervosa, restricting type, muscle strength, exercise, body composition, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
High-Intensity Resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Muscular Strength
Description
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
Time Frame
3 times (week 0, week 8, week 12)
Title
Changes in Agility
Description
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.
Time Frame
3 times (week 0, week 8, week 12)
Title
Changes in Body Composition - Anthropometry
Description
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.
Time Frame
3 times (week 0, week 8, week 12)
Title
Functional Capacity
Description
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).
Time Frame
3 times (week 0, week 8, week 12)
Secondary Outcome Measure Information:
Title
Changes in Spontaneous Physical Activity habits - Accelerometry
Description
Patients were required to maintain their normal physical activity while they were using an uni-axial accelerometer (Actigraph MTI, GT1M model, Manufacturing Technology Inc., Fort Walton Beach, FL, USA). At least 7 days were recorded (Monday-Sunday) with a minimum of 10-hour registration per day was set as an inclusion criterion. The time sampling interval (epoch) was set at 15 seconds. Average physical activity intensity was expressed as (sum of counts registered per epoch)/(Total Time Registered) (cpm). Time spent in light, moderate, vigorous, very vigorous and moderate to vigorous physical activity (MVPA) was presented as means per day depending on the metabolic equivalents (MET). Time spent in low intensity physical activity or sedentary time was the total time registered minus the total time active. Time spent in moderate to vigorous physical activity was presented as means of minutes per day
Time Frame
2 times (week 0, week 8)
Title
Changes in perceived health-related QoL
Description
Patients were requested to fill in the SF-36 questionnaire to assess their perceptions in physical and mental health-related QoL
Time Frame
2 times (week 0, week 8)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: being excessive exercisers (6 hours per week moderate to vigorous physical activity [1952 counts/min] upon admission) not being able to perform physical activity.
Facility Information:
Facility Name
Universidad Europea
City
Villaviciosa de Odon
State/Province
Madrid
ZIP/Postal Code
28670
Country
Spain
Facility Name
Hospital Infantil Universitario Niño Jesús
City
Madrid
ZIP/Postal Code
28009
Country
Spain

12. IPD Sharing Statement

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Effects of a High Intensity Resistance Training in Muscular Strength, Agility, and Body Composition of Anorexia Nervosa Restricting Type Patients

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