AzTrials
AzTrials

Sarcopenic ObesityPhase 2/3NCT02356016

Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity"

A Phase 2/3 study testing WB-EMS Intervention and WB-EMS-Intervention and dietary supplementation in people with Sarcopenic Obesity, run by University of Erlangen-Nürnberg Medical School.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the study is to determine the effect of whole body electromyostimulation (WB-EMS) and/or nutritional on body composition and functional tasks in elderly females with sarcopenic obesity. Read more about this study

Who is it for?
Ages 70 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Sarcopenic Obesity
What is being tested?
WB-EMS Intervention and WB-EMS-Intervention and dietary supplementation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
No sites listed yet
Study dates
Aug 2013to May 2016
Phase
Phase 2/3
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
  • Women only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • community dwelling
  • Sarcopenic Obesity

Who cannot join

  • exercising more than 60 min/week
  • more than 4 weeks absent during the interventional period,
  • injuries (i.e. hip TotalEndoProsthesis (TEP), abdomen/groin hernia) or diseases (i.e. epilepsy, cardiac arrhythmia) that prevent WB-EMS intervention
  • medication and/or diseases affecting our primary endpoints.

About this study

Official title: Effects of Whole-body Electromyostimulation and Dietary Supplements on "Sarcopenic Obesity" in Elderly Females Living in the Community

The aim of the study is to determine the effect of whole body electromyostimulation (WB-EMS) and/or nutritional on body composition and functional tasks in elderly females with sarcopenic obesity. Seventy-five, non-sportive, independently living women 70 years and older with Sarcopenic Obesity were randomly assigned to either a WB-EMS group ( n=25), a WB-EMS/nutritional supplements (n=25) or a semi-active control group (an=25). The WB-EMS protocol applied one session of 18 min/week of WB-EMS (bipolar, 85 Hz). Nutritional strategy based on a high protein supplement.

Being tested
WB-EMS Intervention, WB-EMS-Intervention and dietary supplementation, control (dietary counseling)
Keywords
Sarcopenic Obesity, community dwelling elderly women, electromyostimulation, exercise, dietary supplements
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WB-EMS InterventionBehavioural

    Supervised WB-EMS Intervention 18 min/session (one session/week) and monthly dietary counseling for 6 months

  • WB-EMS-Intervention and dietary supplementationBehavioural

    Supervised WB-EMS Intervention and dietary supplementation and monthly dietary counseling for 6 months

  • control (dietary counseling)Other

    Monthly dietary counseling only

Study groups in NCT02356016
Study groupRoleWhat they receive
Whole body Electromyostimulation (WB-EMS)Active comparator18 min of WB-EMS/week (one session/week)
Receives: Behavioral: WB-EMS Intervention
WB-EMS and Nutritional SupplementsActive comparator18 min of WB-EMS/week (one session/week) and supplements with high protein (Leucin) contents
Receives: Behavioral: WB-EMS-Intervention and dietary supplementation
ControlSham comparatorMonthly dietary counseling for 6 months
Receives: Other: control (dietary counseling)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Appendicular skeletal muscle mass

    changes of appendicular skeletal muscle mass from baseline to 6 month follow-up

    Measured: baseline - 6 months follow-up

  2. Muscle density of the medial thigh

    changes of muscle density (thigh) from baseline to 6 month follow-up

    Measured: baseline - 6 months follow-up

  3. Intramuscular fat content

    changes of Intramuscular fat content (thigh) from baseline to 6 month follow-up

    Measured: baseline - 6 months follow-up

Secondary outcomes (5)

  1. Muscle cross sectional area (CSA)

    changes of muscle CSA (thigh) from baseline to 6 month follow-up

    Measured: baseline - 6 months follow-up

  2. Isokinetic leg strength

    changes of isokinetic leg strength from baseline to 6 month follow-up

    Measured: baseline - 6 months follow-up

  3. Short Physical Performance Battery (SPPB)

    SPPB according to Guralnik et al. (J Gerontol Med Sci1994; 49(2):M85-M94)

    Measured: baseline - 6 months follow-up

  4. Hand grip of the dominant hand

    Maximum isometric strength of the dominant hand (dynamometer)

    Measured: baseline - 6 months follow-up

  5. muscular power of the legs

    Muscular power of the legs (jumping test), by Leonardo (Novotec, Germany)

    Measured: baseline - 6 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2015 (estimated)
  2. Study startAug 2013
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02356016
Sponsor's protocol ID
FORMOsA P2 TP3
Status last verified
May 2016
First submitted
21 Jan 2015
Last updated
23 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Kemmler W, Bebenek M, Engelke K, von Stengel S. Impact of whole-body electromyostimulation on body composition in elderly women at risk for sarcopenia: the Training and ElectroStimulation Trial (TEST-III). Age (Dordr). 2014 Feb;36(1):395-406. doi: 10.1007/s11357-013-9575-2. Epub 2013 Aug 16.

    PubMed 23949160

  • Kemmler W, von Stengel S. Whole-body electromyostimulation as a means to impact muscle mass and abdominal body fat in lean, sedentary, older female adults: subanalysis of the TEST-III trial. Clin Interv Aging. 2013;8:1353-64. doi: 10.2147/CIA.S52337. Epub 2013 Oct 7.

    PubMed 24130433

  • 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 27289534

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing WB-EMS Intervention and WB-EMS-Intervention and dietary supplementation in people with Sarcopenic Obesity, run by University of Erlangen-Nürnberg Medical School.

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 2 inclusion and 4 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 23 May 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Appendicular skeletal muscle mass (time frame: baseline - 6 months follow-up). 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?

On the ClinicalTrials.gov record for NCT02356016, 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 23 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in