Frailty SyndromeNCT04967534
Efficacy of WB-EMS in Frail Older People
A study testing WB-EMS in people with Frailty Syndrome, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Exercise in general and resistance training (RT) in particular have demonstrated positive effects on frailty outcomes, including physical functioning. However, frail older people with functional impairments are among the least physically active and have problems reaching high-intensity levels. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty Syndrome
- What is being tested?
- WB-EMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jul 2021to 15 Mar 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65 years and older
- frail according to Tilburg Frailty Indicator
- residing in assisted living facility or nursing home
- able to walk 4m w/o walking aid but without personal assistance
- no prior WB-EMS exposure
Who cannot join
- severe visual or hearing impairments
- major cognitive impairment (MMSE <10)
- medications with muscle-anabolic effects
- medical conditions affecting trainability of muscles (e.g. Myasthenia gravis, Cushing syndrome, Morbus McArdle)
- surgery within past two months
- history of rhabdomyolysis
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- medical conditions affecting sensation of electrical stimuli (e.g. severe polyneuropathy)
- severe renal insufficiency (eGFR<30 ml/min/1.73m²)
- electronic implants
- acute or untreated abdominal wall or inguinal hernia
- Ventricular arrhythmias requiring therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, University of Erlangen-Nürnberg
Erlangen, Bavaria, 91052
About this study
Official title: The Efficacy of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Randomized Controlled Trial
Exercise in general and resistance training (RT) in particular have demonstrated positive effects on frailty outcomes, including physical functioning. However, frail older people with functional impairments are among the least physically active and have problems reaching high-intensity levels. Whole-body electromyostimulation (WB-EMS) allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at a low subjective effort level. The efficacy of WB-EMS in frail older people has yet to be determined.
The primary objective of this study is to investigate the efficacy of WB-EMS in frail older people.
- Conditions
- Frailty Syndrome
- Being tested
- WB-EMS, social contact control group
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-EMSBehavioural
Simultaneous, individually adjustable stimulation of 12 muscle groups using an interval approach with a duty cycle of 6s impulse/4s rest, bipolar electric current (impulse -frequency 85Hz, -width 350μs, rectangular pattern) will be applied. After a 4-week conditioning period, 1.5x 20 min/week WB-EMS will be conducted for 12 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping, and lower extremity strength will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by the rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)). WB-EMS will be fully supervised one-on-one.
social contact control groupBehavioural
Psycho-social intervention with participants randomized to the control group receiving (if wanted) the same social contact time (20-30 minutes/week) as the WB-EMS group. Depending on personal preferences and Covid-19 restrictions this will be done by phone or in-person one-on-one. Health-related topics and/or general chatting will be offered.
| Study group | Role | What they receive |
|---|---|---|
| WB-EMS | Experimental | Not described Receives: Behavioral: WB-EMS |
| social contact control group | Sham comparator | Not described Receives: Behavioral: social contact control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Extremity Functioning
The Short Physical Performance Battery (SPPB) comprises of three dimensions, balance (static - standing in 3 positions of increasing difficulty by reducing base of support for max. 10s), gait (usual pace - two walks of 4m lengths), functional strength (chair rise - five times sit-to-stand transfers as fast as possible). A sum score is calculated (0-12 points) with higher scores indicating better functional status and each dimension being equally weighed (0-4 points).
Measured: 8 weeks, 16 weeks, 32 weeks
Secondary outcomes (27)
Change in Mobility measured by the Timed up & go test (TUG)
The TUG requires the participants to stand up from a chair, walk at usual pace to line at 3m, turn, walk back and sit down again. The time in seconds is recorded.
Measured: 8 weeks, 16 weeks, 32 weeks
Change in leg strength
Maximal isometric knee extension strength will be assessed on the dominant leg with the participant seated. Three trials will be conducted.
Measured: 8 weeks, 16 weeks, 32 weeks
Change in maximal hand grip strength
Grip strength will be assessed on the dominant hand using a digital dynamometer with the participant seated. Three trials will be conducted.
Measured: 8 weeks, 16 weeks, 32 weeks
Change in gait speed
Gait speed will be assessed over 6 meters under 3 conditions, 1) walking at usual pace, 2) walking at usual pace while counting backwards by 3, 3) walking at fast pace
Measured: 16 weeks, 32 weeks
Change in Choice Stepping Reaction Time (CSRT) test
CSRT time will be measured as the total time to complete 12 steps onto four targets printed on a portable rubber mat following 8 practice trials.
Measured: 16 weeks, 32 weeks
Change in Body Sway
An instrumented test of postural sway (ISway) using a body-worn accelerometer will be used.
Measured: 8 weeks, 16 weeks, 32 weeks
Change in Balance performance
The Berg Balance Scale (BBS) will be used to assess 14 balance tasks of static and dynamic stability. Each task is scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level). The maximum score is 56.
Measured: 16 weeks, 32 weeks
Change in Functional Balance
The Alternate Step Test (AST) measures the time required to place the feet eight times in alternate order on a sturdy step (18 cm high) as fast as possible
Measured: 16 weeks, 32 weeks
Change in Frailty Status
Frailty will be assessed by the Fried Phenotype and the Tilburg Frailty Indicator (TFI).
The Fried phenotype comprises of muscle weakness, fatigue, slowness, low physical activity levels, unintentional weight loss, each scored as 0 (criterion not fulfilled) or 1 (criterion fulfilled). A total sum score of 0 indicates a person is robust, a score of 1 or 2 indicates pre-frailty and a score of 3-5 indicates frailty.
The TFI is a self-reported frailty scale consisting of 3 domains, physical (8 items), psychological (4 items) and social (3 items). A total sum score greater or equal to 5 indicates frailty.
Measured: 16 weeks, 32 weeks
Change in lean mass
Lean mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Measured: 16 weeks, 32 weeks
Change in fat mass
Fat mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Measured: 16 weeks, 32 weeks
Change in Physical Activity
Physical activities will be assessed using a 7-day accelerometry measurement. The device (ActivPAL 3 micro) will be attached to participants' thigh and worn over the complete 7-day/24-hour period.
Measured: 16 weeks
Change in concentration of Triglycerides
Concentration of Triglycerides measured in mg/dl before first and last trainings
Measured: 16 weeks
Change in concentration of total cholesterol
Concentration of Cholesterin measured in mg/dl before first and last trainings
Measured: 16 weeks
Change in concentration of high-density lipoprotein (HDL)
Concentration of HDL measured in mg/dl before first and last trainings
Measured: 16 weeks
Change in concentration of low-density lipoprotein (LDL)
Concentration of LDL measured in mg/dl before first and last trainings
Measured: 16 weeks
Change in concentration of glucose
Concentration of Glucose measured in mg/dl before first and last trainings
Measured: 16 weeks
Change in concentration of Creatinkinase (CK)
Concentration of CK measured in U/l before the first and after the last training
Measured: 8 weeks, 16 weeks
Change in concentration of Creatinine
Concentration of Creatinine measured in mg/dl before the first and after the last training
Measured: 8 weeks, 16 weeks
Change in estimated glomerular filtration rate (eGFR)
eGFR (creatinine clearance) measured in mL/min/1.73m² before the first and after the last training
Measured: 8 weeks, 16 weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Pain and function due to orthopedic problems will be assessed with the WOMAC questionnaire, comprising of 24 items each scored on a 5-point Likert scale.
Measured: 8 weeks, 16 weeks
Change in continence status
Continence status (frequency, severity, perceived burden, timing) will be assessed using the International Consultation on Incontinence Questionnaire (ICIQ, 5 items) and the short form of the Urogenital Distress Inventory (UDI-6, 6 items).
Measured: 16 weeks, 32 weeks
Change in depressive symptoms
Depressive symptoms will be assessed using the Iowa version of the Center for Epidemiologic Studies Depression Scale (CES-D), consisting of 11 items, each scored on a 3-point rating scale. The total sum score is calculated.
Measured: 16 weeks, 32 weeks
Change in concerns about falling
The Falls-efficacy Scale-International (FES-I) questionnaire will be used to assess the concerns about falling during 16 activities of daily living. Each item is scored on a 4-point rating scale and the total sum score is calculated.
Measured: 16 weeks, 32 weeks
Change in Quality of Life (QoL)
QoL will be assessed with 26-item WHOQOL-BREF covering physical health, psychological health, social relationships and environmental aspects. Each item is scored on a 5-point Likert scale.
Measured: 16 weeks
Change in sarcopenia specific QoL
Sarcopenia specific QoL will be assessed with the SarQoL, comprising of 55 items in 22 questions rated on a 4-point Likert scale. Seven domains are specified: Physical and mental health, Locomotion, Body composition, Functionality, Activities of daily living, Leisure activities and Fear.
Measured: 16 weeks, 32 weeks
Change in Health-related Quality of Life (HrQoL)
HrQoL will be assessed using the 4-item HowRu scale comprising of 4 variables: pain or discomfort, feeling low or worried, limitation in activities and dependency on others. Each item is scored on a 4-point visual analogue scale.
Measured: 8 weeks, 16 weeks, 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start21 Jul 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group (1:1) randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Kemmler, PhD, Principal investigator, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967534
- Sponsor's protocol ID
- ETAPPEN_MAIN
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon reasonable request by the principal investigator. IPD relevant to a specific publication will be shared deidentified if it is the respective journal's requirement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04967534
- Acronym / sponsor ID
- ETAPPEN_MAIN
- Conditions
- Frailty Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 19 Jul 2021 (actual)
- 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.
Exercise in general and resistance training (RT) in particular have demonstrated positive effects on frailty outcomes, including physical functioning. However, frail older people with functional impairments are among the least physically active and have problems reaching high-intensity levels. Whole-body electromyostimulation (WB-EMS) allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at a low subjective effort level. The efficacy of WB-EMS in frail older people has yet to be determined.
The primary objective of this study is to investigate the efficacy of WB-EMS in frail older people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel-group (1:1) randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| WB-EMS | Experimental | Behavioral: WB-EMS |
| social contact control group | Sham comparator | Behavioral: social contact control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- aged 65 years and older
- frail according to Tilburg Frailty Indicator
- residing in assisted living facility or nursing home
- able to walk 4m w/o walking aid but without personal assistance
- no prior WB-EMS exposure
Key exclusion criteria (11 listed)
- severe visual or hearing impairments
- major cognitive impairment (MMSE <10)
- medications with muscle-anabolic effects
- medical conditions affecting trainability of muscles (e.g. Myasthenia gravis, Cushing syndrome, Morbus McArdle)
- surgery within past two months
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 |
|---|---|---|
| WB-EMSSimultaneous, individually adjustable stimulation of 12 muscle groups using an interval approach with a duty cycle of 6s impulse/4s rest, bipolar electric current (impulse -frequency 85Hz, -width 350μs, rectangular pattern) will be applied. After a 4-week conditioning period, 1.5x 20 min/week WB-EMS will be conducted for 12 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping, and lower extremity strength will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by the rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)). WB-EMS will be fully supervised one-on-one. | Behavioural | WB-EMS |
| social contact control groupPsycho-social intervention with participants randomized to the control group receiving (if wanted) the same social contact time (20-30 minutes/week) as the WB-EMS group. Depending on personal preferences and Covid-19 restrictions this will be done by phone or in-person one-on-one. Health-related topics and/or general chatting will be offered. | Behavioural | social contact control group |
Primary outcome
Change in Lower Extremity Functioning
Time frame: 8 weeks, 16 weeks, 32 weeks
The Short Physical Performance Battery (SPPB) comprises of three dimensions, balance (static - standing in 3 positions of increasing difficulty by reducing base of support for max. 10s), gait (usual pace - two walks of 4m lengths), functional strength (chair rise - five times sit-to-stand transfers as fast as possible). A sum score is calculated (0-12 points) with higher scores indicating better functional status and each dimension being equally weighed (0-4 points).
27 secondary outcomes
Change in Mobility measured by the Timed up & go test (TUG)
Time frame: 8 weeks, 16 weeks, 32 weeks
Change in leg strength
Time frame: 8 weeks, 16 weeks, 32 weeks
Change in maximal hand grip strength
Time frame: 8 weeks, 16 weeks, 32 weeks
Change in gait speed
Time frame: 16 weeks, 32 weeks
Change in Choice Stepping Reaction Time (CSRT) test
Time frame: 16 weeks, 32 weeks
Change in Body Sway
Time frame: 8 weeks, 16 weeks, 32 weeks
Change in Balance performance
Time frame: 16 weeks, 32 weeks
Change in Functional Balance
Time frame: 16 weeks, 32 weeks
Change in Frailty Status
Time frame: 16 weeks, 32 weeks
Change in lean mass
Time frame: 16 weeks, 32 weeks
Change in fat mass
Time frame: 16 weeks, 32 weeks
Change in Physical Activity
Time frame: 16 weeks
Change in concentration of Triglycerides
Time frame: 16 weeks
Change in concentration of total cholesterol
Time frame: 16 weeks
Change in concentration of high-density lipoprotein (HDL)
Time frame: 16 weeks
Change in concentration of low-density lipoprotein (LDL)
Time frame: 16 weeks
Change in concentration of glucose
Time frame: 16 weeks
Change in concentration of Creatinkinase (CK)
Time frame: 8 weeks, 16 weeks
Change in concentration of Creatinine
Time frame: 8 weeks, 16 weeks
Change in estimated glomerular filtration rate (eGFR)
Time frame: 8 weeks, 16 weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 8 weeks, 16 weeks
Change in continence status
Time frame: 16 weeks, 32 weeks
Change in depressive symptoms
Time frame: 16 weeks, 32 weeks
Change in concerns about falling
Time frame: 16 weeks, 32 weeks
Change in Quality of Life (QoL)
Time frame: 16 weeks
Change in sarcopenia specific QoL
Time frame: 16 weeks, 32 weeks
Change in Health-related Quality of Life (HrQoL)
Time frame: 8 weeks, 16 weeks, 32 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 21 Jul 2022.
- Individual participant dataSharing planned: Yes. IPD will be shared upon reasonable request by the principal investigator. IPD relevant to a specific publication will be shared deidentified if it is the respective journal's requirement.
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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.
Wolfgang Kemmler, PhD principal investigator
University of Erlangen-Nürnberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WB-EMS in people with Frailty Syndrome, 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 5 inclusion and 11 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 21 Jul 2022. 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. 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.
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 in Lower Extremity Functioning (time frame: 8 weeks, 16 weeks, 32 weeks). 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 21 Jul 2022.