Anorexia Nervosa Restricting TypeNCT01906320
Effects of a High Intensity Resistance Training in Muscular Strength, Agility, and Body Composition of Anorexia Nervosa Restricting Type Patients
A study testing High-Intensity Resistance training in people with Anorexia Nervosa Restricting Type, run by Universidad Europea de Madrid at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 16 years, women only
- Conditions the study is for
- Anorexia Nervosa Restricting Type
- What is being tested?
- High-Intensity Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- being excessive exercisers (6 hours per week moderate to vigorous physical activity [1952 counts/min] upon admission)
- not being able to perform physical activity.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Infantil Universitario Niño Jesús
Madrid, 28009
Universidad Europea
Villaviciosa de Odón, Madrid, 28670
About this study
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.
- Conditions
- Anorexia Nervosa Restricting Type
- Being tested
- High-Intensity Resistance training
- Keywords
- anorexia nervosa, restricting type, muscle strength, exercise, body composition, physical activity
- Medical subject headings
- Anorexia Nervosa, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Resistance trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Not described Receives: Behavioral: High-Intensity Resistance training |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 3 times (week 0, week 8, week 12)
Secondary outcomes (2)
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
Measured: 2 times (week 0, week 8)
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
Measured: 2 times (week 0, week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJan 2009
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia Nervosa Restricting TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Responsible party
- Principal investigator, Maria Fernandez del Valle, PhD, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906320
- Sponsor's protocol ID
- R-0034/08-1
- Status last verified
- Dec 2020
- First submitted
- 17 Jul 2013
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a High Intensity Resistance Training in Muscular Strength, Agility, and Body Composition of Anorexia Nervosa Restricting Type Patients
- ClinicalTrials.gov ID
- NCT01906320
- Acronym / sponsor ID
- R-0034/08-1
- Conditions
- Anorexia Nervosa Restricting Type
- Keywords
- anorexia nervosa, restricting type, muscle strength, exercise, body composition, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Study start
- Jan 2009 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Behavioral: High-Intensity Resistance training |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- being excessive exercisers (6 hours per week moderate to vigorous physical activity [1952 counts/min] upon admission)
- not being able to perform physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Resistance trainingIntervention 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. | Behavioural | Training group |
Primary outcome
Changes in Muscular Strength
Time frame: 3 times (week 0, week 8, week 12)
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
Time frame: 3 times (week 0, week 8, week 12)
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
Time frame: 3 times (week 0, week 8, week 12)
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
Time frame: 3 times (week 0, week 8, week 12)
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).
2 secondary outcomes
Changes in Spontaneous Physical Activity habits - Accelerometry
Time frame: 2 times (week 0, week 8)
Changes in perceived health-related QoL
Time frame: 2 times (week 0, week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Resistance training in people with Anorexia Nervosa Restricting Type, run by Universidad Europea de Madrid at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Muscular Strength (time frame: 3 times (week 0, week 8, week 12)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.