Pediatric ObesityNCT02545764
Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children
A study testing Strength and neuromuscular exercise programme in people with Pediatric Obesity and Lower Extremity Biomechanics, run by St. Pölten University of Applied Sciences at 1 site in Austria.
Trial summary
Childhood obesity is one of the most critical and accelerating health challenges throughout the world. It is a major risk factor for developing varus/valgus misalignments of the knee joint. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pediatric Obesity, Lower Extremity Biomechanics
- What is being tested?
- Strength and neuromuscular exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2015to May 2017
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female
- Age: 10 -18 years
- BMI greater than the 97th percentile
- Availability: can participate in two exercises session per week for a period of 12 weeks
Who cannot join
- Present syndromes
- Chronic joint diseases, osteoarthritic surgery or
- Neuro-motor diseases
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Paediatrics and Adolescent Medicine, Medical University of Vienna
Vienna
About this study
Official title: The Effects of a Strength and Neuromuscular Exercise Programme for the Lower Extremity on Knee Load, Pain and Function in Obese Children and Adolescents: a Randomised, Single-blinded Controlled Trial
Childhood obesity is one of the most critical and accelerating health challenges throughout the world. It is a major risk factor for developing varus/valgus misalignments of the knee joint. The combination of misalignment at the knee and excess body mass may result in increased joint stress and damage to articular cartilage. A training programme, which aims at developing a more neutral alignment of the trunk and lower limbs during movement tasks may be able to reduce knee loading during locomotion. Despite the large number of guidelines for muscle strength training and neuromuscular exercises that exists, most are not specifically designed to target the obese children and adolescent demographic.
The purpose of this study is to evaluate a training programme which combines strength and neuromuscular exercises specifically designed to the needs and limitations of obese children and adolescents and analyse the effects of the training programme from a biomechanical and clinical point of view.
- Conditions
- Pediatric Obesity, Lower Extremity Biomechanics
- Being tested
- Strength and neuromuscular exercise programme
- Keywords
- Gait Analysis, Knee Adduction Moment, Physiotherapy, Obesity
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength and neuromuscular exercise programmeOther
12 weeks strength and neuromuscular exercise programme for the lower extremity
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Strength and neuromuscular exercise programme Receives: Other: Strength and neuromuscular exercise programme |
| Control | No intervention | Control group will receive opportunity for the training programme after data capturing is finished |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall peak external frontal knee moment and impulse
Assessed by 3D gait analysis during walking
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Physical examination
Changes of function and strength of the targeted muscle groups will be assessed by a physical therapist. Therefore, a hand-dynamometer to investigate differences in muscle strength will be used.
Measured: Baseline and 12 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Austria-German version of the Knee Injury and Osteoarthritis Outcome Score will be used to assess the participants' opinion about their knee.
Measured: Baseline and 12 weeks
Gait pattern
Kinematics and external joint moments for the sagittal and frontal plane for hip, knee and ankle joints as well as spatio-temporal parameters will be assessed by 3D gait analysis during walking and stair climbing.
Measured: Baseline and 12 weeks
Adherence to the training programme
Adherence will be considered as the percentage of actually completed sessions during the intervention period among the number of intended exercise sessions.
Measured: Participants will be followed for the duration of the intervention (12 weeks)
Ratings of knee related pain
Ratings of knee related pain will be assessed using a 7-point ordinal scale.
Measured: Participants will be followed for the duration of the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies 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
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Pölten University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna, Medical University of Vienna, Danube University Krems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545764
- Sponsor's protocol ID
- LS13-009
- Status last verified
- Jul 2018
- First submitted
- 28 Aug 2015
- Last updated
- 17 Jul 2018
- Results posted
- No
Publications
Kreissl A, Jorda A, Truschner K, Skacel G, Greber-Platzer S. Clinically relevant body composition methods for obese pediatric patients. BMC Pediatr. 2019 Mar 21;19(1):84. doi: 10.1186/s12887-019-1454-2.
PubMed 30898093Horsak B, Schwab C, Baca A, Greber-Platzer S, Kreissl A, Nehrer S, Keilani M, Crevenna R, Kranzl A, Wondrasch B. Effects of a lower extremity exercise program on gait biomechanics and clinical outcomes in children and adolescents with obesity: A randomized controlled trial. Gait Posture. 2019 May;70:122-129. doi: 10.1016/j.gaitpost.2019.02.032. Epub 2019 Feb 27.
PubMed 30851623Horsak B, Artner D, Baca A, Pobatschnig B, Greber-Platzer S, Nehrer S, Wondrasch B. The effects of a strength and neuromuscular exercise programme for the lower extremity on knee load, pain and function in obese children and adolescents: study protocol for a randomised controlled trial. Trials. 2015 Dec 23;16:586. doi: 10.1186/s13063-015-1091-5.
PubMed 26700568
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Strength and Neuromuscular Exercise Programme for the Lower Extremity on Knee Load, Pain and Function in Obese Children and Adolescents: a Randomised, Single-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT02545764
- Acronym / sponsor ID
- LS13-009
- Conditions
- Pediatric Obesity, Lower Extremity Biomechanics
- Keywords
- Gait Analysis, Knee Adduction Moment, Physiotherapy, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- St. Pölten University of Applied SciencesUniversity, hospital or other
- Collaborators
- University of Vienna, Medical University of Vienna, Danube University Krems
- Study start
- Sep 2015
- Primary completion
- May 2017 (actual)
- First posted
- 10 Sep 2015 (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.
Childhood obesity is one of the most critical and accelerating health challenges throughout the world. It is a major risk factor for developing varus/valgus misalignments of the knee joint. The combination of misalignment at the knee and excess body mass may result in increased joint stress and damage to articular cartilage. A training programme, which aims at developing a more neutral alignment of the trunk and lower limbs during movement tasks may be able to reduce knee loading during locomotion. Despite the large number of guidelines for muscle strength training and neuromuscular exercises that exists, most are not specifically designed to target the obese children and adolescent demographic.
The purpose of this study is to evaluate a training programme which combines strength and neuromuscular exercises specifically designed to the needs and limitations of obese children and adolescents and analyse the effects of the training programme from a biomechanical and clinical point of view.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Strength and neuromuscular exercise programmeStrength and neuromuscular exercise programme |
| Control | No intervention | –Control group will receive opportunity for the training programme after data capturing is finished |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female
- Age: 10 -18 years
- BMI greater than the 97th percentile
- Availability: can participate in two exercises session per week for a period of 12 weeks
Key exclusion criteria (3 listed)
- Present syndromes
- Chronic joint diseases, osteoarthritic surgery or
- Neuro-motor diseases
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 |
|---|---|---|
| Strength and neuromuscular exercise programme12 weeks strength and neuromuscular exercise programme for the lower extremity | Other | Intervention |
Primary outcome
Overall peak external frontal knee moment and impulse
Time frame: Baseline and 12 weeks
Assessed by 3D gait analysis during walking
5 secondary outcomes
Physical examination
Time frame: Baseline and 12 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline and 12 weeks
Gait pattern
Time frame: Baseline and 12 weeks
Adherence to the training programme
Time frame: Participants will be followed for the duration of the intervention (12 weeks)
Ratings of knee related pain
Time frame: Participants will be followed for the duration of the intervention (12 weeks)
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 17 Jul 2018.
- Derived from this study: PubMed 30898093Kreissl A, Jorda A, Truschner K, Skacel G, Greber-Platzer S. Clinically relevant body composition methods for obese pediatric patients. BMC Pediatr. 2019 Mar 21;19(1):84. doi: 10.1186/s12887-019-1454-2.
- Derived from this study: PubMed 30851623Horsak B, Schwab C, Baca A, Greber-Platzer S, Kreissl A, Nehrer S, Keilani M, Crevenna R, Kranzl A, Wondrasch B. Effects of a lower extremity exercise program on gait biomechanics and clinical outcomes in children and adolescents with obesity: A randomized controlled trial. Gait Posture. 2019 May;70:122-129. doi: 10.1016/j.gaitpost.2019.02.032. Epub 2019 Feb 27.
- Derived from this study: PubMed 26700568Horsak B, Artner D, Baca A, Pobatschnig B, Greber-Platzer S, Nehrer S, Wondrasch B. The effects of a strength and neuromuscular exercise programme for the lower extremity on knee load, pain and function in obese children and adolescents: study protocol for a randomised controlled trial. Trials. 2015 Dec 23;16:586. doi: 10.1186/s13063-015-1091-5.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength and neuromuscular exercise programme in people with Pediatric Obesity and Lower Extremity Biomechanics, run by St. Pölten University of Applied Sciences at 1 site in Austria.
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 3 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Overall peak external frontal knee moment and impulse (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02545764, which also lists 3 linked publications.
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 17 Jul 2018.