Sarcopenic ObesityPhase 3FRANSONCT02857660
Effect of Whole Body Electromyostimulation and/or Protein Supplementation on Sarcopenic Obesity in 70+
A Phase 3 study testing Whole body Electromyostimulation (exercise) and Protein in people with Sarcopenic Obesity, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The aim of the study is to determine the effect of 16 weeks of Whole Body-Electromyostimulation (WB-EMS) and/or protein supplementation on Sarcopenic Obesity (SO) in community dwelling male subjects 70+ with SO . Read more about this study
- Who is it for?
- Ages 70 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- Whole body Electromyostimulation (exercise) and Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Apr 2017
- Phase
- Phase 3
- 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 70 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- community dwelling, independent living men
- Sarcopenia
- Obesity (body fat >=25%)
Who cannot join
- exclusion criteria for WB-EMS-application (e.g. cardiac pacemaker)
- diseases/medication that affect the study endpoints (e.g. Glucocorticoids >5mg/d)
- absence of more than 2 weeks during the study period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, Friedrich Alexander University Erlangen-Nürnberg
Erlangen, Bavaria, 91052
About this study
Official title: Effect of Whole-body Electromyostimulation (WB-EMS) and/or Protein Supplementation on Sarcopenic Obesity in Community Dwelling Males 70+ With Sarcopenic Obesity
The aim of the study is to determine the effect of 16 weeks of Whole Body-Electromyostimulation (WB-EMS) and/or protein supplementation on Sarcopenic Obesity (SO) in community dwelling male subjects 70+ with SO .
108 eligible men will be randomly assigned to either a (1) WB-EMS and Protein (2) Protein (3) sedentary control group.
WB-EMS will be applied 1,5 x 20 min per week (i.e. 3 sessions in two weeks) with bipolar current, 85 Hz in an intermitted mode (4 s - 4 s of rest). Protein supplementation will be adjusted to dietary intake in order to reach a total protein intake between 1,5 - 1,7g/kg body-mass/d . Primary study endpoint will be the Sarcopenia Z-Score
Read the detailed description
The aim of the study is to evaluate the effects of Whole-Body Electromyostimulation (WB-EMS) with additional protein supplementation on Sarcopenic Obesity parameters in independently living men 70 years and older with sarcopenic obesity. The randomized controlled study compares three groups with 36 subjects each: (1) WB-EMS with additional protein supplementation, (2) protein-only and (3) passive control group, over a period of 16 weeks of WB-EMS -training. Group (1) conducts 1.5-times/week a 20 minute-sessions of WB-EMS with additional protein, group (2) is limited to protein supplementation (only) and group (3) is constrained to maintain their habitual living behavior and physical activity. Based on an individual nutrition analysis the protein intake will be adjusted to 1.5-1.7 g/kg/ bodymass/d. All groups will be supplemented with a maximum of 800 IE Vitamin D.
Primary study endpoint will be changes of the Sarcopenia Z-Score with skeletal muscle mass assessed via bio-impedance analysis (BIA). Secondary study endpoints are changes of Obesity (i.e. body-fat as assessed via BIA), cardiometabolic risk (i.e. Metabolic Syndrome Z-Score), strength parameters evaluated via Dr. Wolff BackCheck and Physiomed LegPress, quality of life (SF-12) and functional disability (late life physical disability index).
- Conditions
- Sarcopenic Obesity
- Being tested
- Whole body Electromyostimulation (exercise), Protein
- Keywords
- Sarcopenia, Obesity, Whole-Body Electromyostimulation, Protein Supplementation, community dwelling men
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body Electromyostimulation (exercise)Other
Also called Electrostimulation
1.5 x 20 min/week (e.g. each Tuesday and every second Friday) with bipolar current, 85 Hz, 360 µs, rectangular mode, intermittent with 4 sec of current and 4 s of rest.
ProteinDietary supplement
up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)
| Study group | Role | What they receive |
|---|---|---|
| Whole-Body Electromyostimulation and Protein | Experimental | 16 weeks of whole-body intervention 1.5 x 20 min week with bipolar current up to 1.5 - 1.7 g/kg body mass/d of protein supplements up to 800 IU/d Vitamin D-Supplementation Receives: Other: Whole body Electromyostimulation (exercise); Dietary Supplement: Protein |
| Protein supplementation | Active comparator | up to 1.5 - 1.7 g/kg body mass/d of protein supplements up to 800 IU/d Vitamin D-Supplementation Receives: Dietary Supplement: Protein |
| sedentary Control Group | No intervention | No protein supplementation or WB-EMS-application, but up to 800 IU/d Vitamin D-Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Sarcopenia Z-Score
ie. Z-Score generated by skeletal muscle index, gait speed and grip-strength according to the Sarcopenia Definition of the European Working Group on Sarcopenia in Older People
Measured: Change from Baseline Sarcopenia Z-Score at 16 weeks
Change of Obesity
Assessment of body fat content and body mass index
Measured: Change from Baseline Obesity at 16 weeks
Secondary outcomes (5)
Change of Metabolic Syndrome Z-Score
Metabolic Syndrome according to the International Diabetes Federation (IDF)
Measured: Change from Baseline Metabolic Syndrome Z-Score at 16 weeks
Change of isokinetic leg strength
Dynamic strength of the leg extensors and flexors as determined by a isokinetic leg press
Measured: Change from Baseline isokinetic leg strength at 16 weeks
Change of Quality of Life
Quality of life as determined by the SF-12 questionnaire
Measured: Change from Baseline Quality of life at 16 weeks
Change of Physical Disability
Physical disability as assessed by Late Life Functional and Disability Index (LLFDI)
Measured: Change from Baseline Physical Disability at 16 weeks
Change of Back Extensors Strength
Strength of the back extensors and flexors using the Doctor Wolff Backcheck device
Measured: Change from Baseline Back Extensors Strength at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Erlangen-Nürnberg
- Responsible party
- Sponsor
- Investigators
- Cornel Sieber, MD, Study chair, Institute of Biomedicine of Aging, University of Erlangen-NürnbergKlaus Engelke, PhD, Study chair, University of Erlangen-Nürnberg Medical SchoolEllen Freiberger, PhD, Study chair, Institute of Biomedicine of Aging, University of Erlangen-NürnbergAnja Weissenfels, MA, Principal investigator, University of Erlangen-Nürnberg Medical SchoolWolfgang Kemmler, PhD, Study director, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857660
- Sponsor's protocol ID
- FRANSO_2016_IMP
- Acronym
- FRANSO
- Status last verified
- May 2017
- First submitted
- 28 Jul 2016
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kemmler W, Teschler M, Weissenfels A, Bebenek M, von Stengel S, Kohl M, Freiberger E, Goisser S, Jakob F, Sieber C, Engelke K. Whole-body electromyostimulation to fight sarcopenic obesity in community-dwelling older women at risk. Resultsof the randomized controlled FORMOsA-sarcopenic obesity study. Osteoporos Int. 2016 Nov;27(11):3261-3270. doi: 10.1007/s00198-016-3662-z. Epub 2016 Jun 12.
PubMed 27289534Kemmler W, Teschler M, Goisser S, Bebenek M, von Stengel S, Bollheimer LC, Sieber CC, Freiberger E. Prevalence of sarcopenia in Germany and the corresponding effect of osteoarthritis in females 70 years and older living in the community: results of the FORMoSA study. Clin Interv Aging. 2015 Oct 3;10:1565-73. doi: 10.2147/CIA.S89585. eCollection 2015.
PubMed 26491272Kemmler W, von Stengel S, Engelke K, Sieber C, Freiberger E. Prevalence of sarcopenic obesity in Germany using established definitions: Baseline data of the FORMOsA study. Osteoporos Int. 2016 Jan;27(1):275-81. doi: 10.1007/s00198-015-3303-y. Epub 2015 Aug 29.
PubMed 26318759Goisser S, Kemmler W, Porzel S, Volkert D, Sieber CC, Bollheimer LC, Freiberger E. Sarcopenic obesity and complex interventions with nutrition and exercise in community-dwelling older persons--a narrative review. Clin Interv Aging. 2015 Aug 6;10:1267-82. doi: 10.2147/CIA.S82454. eCollection 2015.
PubMed 26346071Chaudry O, Friedberger A, Grimm A, Uder M, Nagel AM, Kemmler W, Engelke K. Segmentation of the fascia lata and reproducible quantification of intermuscular adipose tissue (IMAT) of the thigh. MAGMA. 2021 Jun;34(3):367-376. doi: 10.1007/s10334-020-00878-w. Epub 2020 Aug 6.
PubMed 32761398Kemmler W, Grimm A, Bebenek M, Kohl M, von Stengel S. Effects of Combined Whole-Body Electromyostimulation and Protein Supplementation on Local and Overall Muscle/Fat Distribution in Older Men with Sarcopenic Obesity: The Randomized Controlled Franconia Sarcopenic Obesity (FranSO) Study. Calcif Tissue Int. 2018 Sep;103(3):266-277. doi: 10.1007/s00223-018-0424-2. Epub 2018 Apr 19.
PubMed 29675640Kemmler W, Kohl M, Freiberger E, Sieber C, von Stengel S. Effect of whole-body electromyostimulation and / or protein supplementation on obesity and cardiometabolic risk in older men with sarcopenic obesity: the randomized controlled FranSO trial. BMC Geriatr. 2018 Mar 9;18(1):70. doi: 10.1186/s12877-018-0759-6.
PubMed 29523089Kemmler W, Teschler M, Weissenfels A, Sieber C, Freiberger E, von Stengel S. Prevalence of sarcopenia and sarcopenic obesity in older German men using recognized definitions: high accordance but low overlap! Osteoporos Int. 2017 Jun;28(6):1881-1891. doi: 10.1007/s00198-017-3964-9. Epub 2017 Feb 20.
PubMed 28220197
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-body Electromyostimulation (WB-EMS) and/or Protein Supplementation on Sarcopenic Obesity in Community Dwelling Males 70+ With Sarcopenic Obesity
- ClinicalTrials.gov ID
- NCT02857660
- Acronym / sponsor ID
- FRANSO / FRANSO_2016_IMP
- Conditions
- Sarcopenic Obesity
- Keywords
- Sarcopenia, Obesity, Whole-Body Electromyostimulation, Protein Supplementation, community dwelling men
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- University of Erlangen-Nürnberg
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 Aug 2016 (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 of the study is to determine the effect of 16 weeks of Whole Body-Electromyostimulation (WB-EMS) and/or protein supplementation on Sarcopenic Obesity (SO) in community dwelling male subjects 70+ with SO .
108 eligible men will be randomly assigned to either a (1) WB-EMS and Protein (2) Protein (3) sedentary control group.
WB-EMS will be applied 1,5 x 20 min per week (i.e. 3 sessions in two weeks) with bipolar current, 85 Hz in an intermitted mode (4 s - 4 s of rest). Protein supplementation will be adjusted to dietary intake in order to reach a total protein intake between 1,5 - 1,7g/kg body-mass/d . Primary study endpoint will be the Sarcopenia Z-Score
Detailed description
The aim of the study is to evaluate the effects of Whole-Body Electromyostimulation (WB-EMS) with additional protein supplementation on Sarcopenic Obesity parameters in independently living men 70 years and older with sarcopenic obesity. The randomized controlled study compares three groups with 36 subjects each: (1) WB-EMS with additional protein supplementation, (2) protein-only and (3) passive control group, over a period of 16 weeks of WB-EMS -training. Group (1) conducts 1.5-times/week a 20 minute-sessions of WB-EMS with additional protein, group (2) is limited to protein supplementation (only) and group (3) is constrained to maintain their habitual living behavior and physical activity. Based on an individual nutrition analysis the protein intake will be adjusted to 1.5-1.7 g/kg/ bodymass/d. All groups will be supplemented with a maximum of 800 IE Vitamin D.
Primary study endpoint will be changes of the Sarcopenia Z-Score with skeletal muscle mass assessed via bio-impedance analysis (BIA). Secondary study endpoints are changes of Obesity (i.e. body-fat as assessed via BIA), cardiometabolic risk (i.e. Metabolic Syndrome Z-Score), strength parameters evaluated via Dr. Wolff BackCheck and Physiomed LegPress, quality of life (SF-12) and functional disability (late life physical disability index).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole-Body Electromyostimulation and Protein | Experimental | Other: Whole body Electromyostimulation (exercise), Dietary Supplement: Protein16 weeks of whole-body intervention 1.5 x 20 min week with bipolar current up to 1.5 - 1.7 g/kg body mass/d of protein supplements up to 800 IU/d Vitamin D-Supplementation |
| Protein supplementation | Active comparator | Dietary Supplement: Proteinup to 1.5 - 1.7 g/kg body mass/d of protein supplements up to 800 IU/d Vitamin D-Supplementation |
| sedentary Control Group | No intervention | –No protein supplementation or WB-EMS-application, but up to 800 IU/d Vitamin D-Supplementation |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- community dwelling, independent living men
- Sarcopenia
- Obesity (body fat >=25%)
Key exclusion criteria (3 listed)
- exclusion criteria for WB-EMS-application (e.g. cardiac pacemaker)
- diseases/medication that affect the study endpoints (e.g. Glucocorticoids >5mg/d)
- absence of more than 2 weeks during the study period
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 |
|---|---|---|
| Whole body Electromyostimulation (exercise)Also: Electrostimulation1.5 x 20 min/week (e.g. each Tuesday and every second Friday) with bipolar current, 85 Hz, 360 µs, rectangular mode, intermittent with 4 sec of current and 4 s of rest. | Other | Whole-Body Electromyostimulation and Protein |
| Proteinup to 1.5-1.7 g/kg bodymass/d of protein (whey protein) | Dietary supplement | Protein supplementation, Whole-Body Electromyostimulation and Protein |
Primary outcome
Change of Sarcopenia Z-Score
Time frame: Change from Baseline Sarcopenia Z-Score at 16 weeks
ie. Z-Score generated by skeletal muscle index, gait speed and grip-strength according to the Sarcopenia Definition of the European Working Group on Sarcopenia in Older People
Change of Obesity
Time frame: Change from Baseline Obesity at 16 weeks
Assessment of body fat content and body mass index
5 secondary outcomes
Change of Metabolic Syndrome Z-Score
Time frame: Change from Baseline Metabolic Syndrome Z-Score at 16 weeks
Change of isokinetic leg strength
Time frame: Change from Baseline isokinetic leg strength at 16 weeks
Change of Quality of Life
Time frame: Change from Baseline Quality of life at 16 weeks
Change of Physical Disability
Time frame: Change from Baseline Physical Disability at 16 weeks
Change of Back Extensors Strength
Time frame: Change from Baseline Back Extensors Strength at 16 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 2 May 2017.
- Background: PubMed 27289534Kemmler W, Teschler M, Weissenfels A, Bebenek M, von Stengel S, Kohl M, Freiberger E, Goisser S, Jakob F, Sieber C, Engelke K. Whole-body electromyostimulation to fight sarcopenic obesity in community-dwelling older women at risk. Resultsof the randomized controlled FORMOsA-sarcopenic obesity study. Osteoporos Int. 2016 Nov;27(11):3261-3270. doi: 10.1007/s00198-016-3662-z. Epub 2016 Jun 12.
- Background: PubMed 26491272Kemmler W, Teschler M, Goisser S, Bebenek M, von Stengel S, Bollheimer LC, Sieber CC, Freiberger E. Prevalence of sarcopenia in Germany and the corresponding effect of osteoarthritis in females 70 years and older living in the community: results of the FORMoSA study. Clin Interv Aging. 2015 Oct 3;10:1565-73. doi: 10.2147/CIA.S89585. eCollection 2015.
- Background: PubMed 26318759Kemmler W, von Stengel S, Engelke K, Sieber C, Freiberger E. Prevalence of sarcopenic obesity in Germany using established definitions: Baseline data of the FORMOsA study. Osteoporos Int. 2016 Jan;27(1):275-81. doi: 10.1007/s00198-015-3303-y. Epub 2015 Aug 29.
- Background: PubMed 26346071Goisser S, Kemmler W, Porzel S, Volkert D, Sieber CC, Bollheimer LC, Freiberger E. Sarcopenic obesity and complex interventions with nutrition and exercise in community-dwelling older persons--a narrative review. Clin Interv Aging. 2015 Aug 6;10:1267-82. doi: 10.2147/CIA.S82454. eCollection 2015.
- Derived from this study: PubMed 32761398Chaudry O, Friedberger A, Grimm A, Uder M, Nagel AM, Kemmler W, Engelke K. Segmentation of the fascia lata and reproducible quantification of intermuscular adipose tissue (IMAT) of the thigh. MAGMA. 2021 Jun;34(3):367-376. doi: 10.1007/s10334-020-00878-w. Epub 2020 Aug 6.
- Derived from this study: PubMed 29675640Kemmler W, Grimm A, Bebenek M, Kohl M, von Stengel S. Effects of Combined Whole-Body Electromyostimulation and Protein Supplementation on Local and Overall Muscle/Fat Distribution in Older Men with Sarcopenic Obesity: The Randomized Controlled Franconia Sarcopenic Obesity (FranSO) Study. Calcif Tissue Int. 2018 Sep;103(3):266-277. doi: 10.1007/s00223-018-0424-2. Epub 2018 Apr 19.
- Derived from this study: PubMed 29523089Kemmler W, Kohl M, Freiberger E, Sieber C, von Stengel S. Effect of whole-body electromyostimulation and / or protein supplementation on obesity and cardiometabolic risk in older men with sarcopenic obesity: the randomized controlled FranSO trial. BMC Geriatr. 2018 Mar 9;18(1):70. doi: 10.1186/s12877-018-0759-6.
- Derived from this study: PubMed 28220197Kemmler W, Teschler M, Weissenfels A, Sieber C, Freiberger E, von Stengel S. Prevalence of sarcopenia and sarcopenic obesity in older German men using recognized definitions: high accordance but low overlap! Osteoporos Int. 2017 Jun;28(6):1881-1891. doi: 10.1007/s00198-017-3964-9. Epub 2017 Feb 20.
- Individual participant dataSharing planned: No
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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.
Cornel Sieber, MD study chair
Institute of Biomedicine of Aging, University of Erlangen-Nürnberg
Klaus Engelke, PhD study chair
University of Erlangen-Nürnberg Medical School
Ellen Freiberger, PhD study chair
Institute of Biomedicine of Aging, University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Whole body Electromyostimulation (exercise) and Protein in people with Sarcopenic Obesity, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 3 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 2 May 2017. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of Sarcopenia Z-Score (time frame: Change from Baseline Sarcopenia Z-Score at 16 weeks). The study lists 2 primary outcomes in all. 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 NCT02857660, which also lists 8 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 2 May 2017.