AnorexiaNCT00829946
Effects of Resistance Strength Training on Functional Capacity and Well Being of Anorexic Patients
A study testing Physical activity in people with Anorexia, run by Universidad Europea de Madrid.
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). Read more about this study
- Who is it for?
- Ages Up to 16 years, women only
- Conditions the study is for
- Anorexia
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 2008
- 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 Up to 16 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: Effects of Resistance Strength Training on Functional Capacity and Well Being of Anorexic Patients; A Randomized Controlled Trial
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.
Read the detailed 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
- Conditions
- Anorexia
- Being tested
- Physical activity
- Keywords
- Strength training, Anorexia, Girls, Quality of life, Functional mobility
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Not described Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Anthropometry
Functional mobility
Secondary outcomes (2)
Muscular strength
Cardiorespiratory fitness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies 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
- Enrolment
- 35 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829946
- Sponsor's protocol ID
- R-0034/08
- Status last verified
- Jan 2009
- First submitted
- 26 Jan 2009
- Last updated
- 27 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Strength Training on Functional Capacity and Well Being of Anorexic Patients; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00829946
- Acronym / sponsor ID
- R-0034/08
- Conditions
- Anorexia
- Keywords
- Strength training, Anorexia, Girls, Quality of life, Functional mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Study start
- Jan 2008
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 27 Jan 2009 (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 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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Behavioral: Physical activity |
Who may qualify
- Ages
- Up to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Physical activityParticipants 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. | Behavioural | 2 |
Primary outcome
Quality of life
Anthropometry
Functional mobility
2 secondary outcomes
Muscular strength
Cardiorespiratory fitness
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 27 Jan 2009.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Anorexia, run by Universidad Europea de Madrid.
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 1 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 27 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Quality of life. The study lists 3 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 27 Jan 2009.