FrailtyNCT04495647
Feasibility of WB-EMS in Frail Older People
A study testing Whole-Body Electromyostimulation in people with Frailty and Mobility Limitation, 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 physical functioning and frailty. However, frail older people with functional impairments are among the least physically active and may have problems reaching high intensity levels. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Mobility Limitation
- What is being tested?
- Whole-Body Electromyostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jul 2020to 28 Feb 2021
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 75+ years
- Frail
- able to walk 4m w/o walking aid
- no prior WB-EMS exposure
- 75+ years
- Robust
Show all 10Show fewer
- no prior WB-EMS exposure
- 18-50 years
- Healthy
- 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
Show all 33Show fewer
- 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
- Robust people
- 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
- 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
- Younger people
- 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
- 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
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, University of Erlangen-Nürnberg
Erlangen, 91052
About this study
Official title: Feasibility and Safety of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Pilot Study
Exercise in general and resistance training (RT) in particular have demonstrated positive effects on physical functioning and frailty. However, frail older people with functional impairments are among the least physically active and may have problems reaching high intensity levels. The use of special vests with integrated electrodes allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at low subjective effort level. This whole-body electromyostimulation (WB-EMS) may be a feasible option inducing training stimuli for functionally impaired frail older people.
This study aims at investigating the feasibility and safety of WB-EMS in frail older people with functional limitations. To explore the effects of age and functional status, young and robust old reference groups will serve as comparators.
- Conditions
- Frailty, Mobility Limitation
- Being tested
- Whole-Body Electromyostimulation
- Medical subject headings
- Frailty, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body ElectromyostimulationOther
Whole-Body Electromyostimulation (WB-EMS): 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 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)).
WB-EMS will be fully supervised one on one.
All three arms will receive the same intervention.
| Study group | Role | What they receive |
|---|---|---|
| WB-EMS_frail | Experimental | Not described Receives: Other: Whole-Body Electromyostimulation |
| WB-EMS_robust | Active comparator | Not described Receives: Other: Whole-Body Electromyostimulation |
| WB-EMS_young | Active comparator | Not described Receives: Other: Whole-Body Electromyostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
measured by ratio of included/eligible participants
Measured: 8 weeks
Compliance
measured by proportion of attended training sessions
Measured: from baseline to 8 weeks
Retention rate
measured by proportion of participants remaining in the study
Measured: at 8 weeks
Dropout rate
measured by the proportion of participants not completing the study
Measured: from baseline to 8 weeks
Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)
The PACES-8 comprises of 8 items on a 7-point bipolar rating scale. A sum score is calculated with higher PACES scores reflecting greater levels of enjoyment.
Measured: Change from baseline to 8 weeks
Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)
The HRERS, reported by instructors, comprises of 5 items on a verbal rating scale from 'Never' to 'Always'. Higher scores reflect greater levels of engagement.
Measured: at 8 weeks
Concentration of Myoglobin (MB)
Concentration of MB measured in µg/l 3 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Concentration of Creatinkinase (CK)
Concentration of CK measured in U/l before, 48, 72 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
estimated glomerular filtration rate (eGFR)
eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Secondary outcomes (17)
Rhabdomyolysis surveillance measured by a self-developed questionnaire
The questionnaire is to be filled out before, immediately after and 24 hours following training and containing information on specific (dark urine, muscle weakness, muscle pain) and unspecific (tachycardia, fever, general malaise, nausea, vomiting) symptoms and other adverse events (e.g. falls)
Measured: measured weekly
Pain assessed by the Brief Pain Inventory (BPI-SF)
The BPI-SF comprises of 15 items asking questions on pain location, severity and interference and scored from 0 to 10 with higher scores indicating worse outcomes.
Measured: measured at baseline to week 1, week 3 and week 8
Fatigue assessed by the Brief Fatigue Inventory (BFI)
The BFI comprises of 10 items asking questions on fatigue severity and interference and scored from 0 to 10 with higher scores indicating worse outcomes.
Measured: measured at baseline to week 1, week 3 and week 8
System usability measured by the System Usability Scale (SUS)
The SUS, reported by instructors, comprises of 10 items on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'). Higher scores reflect greater levels of usability.
Measured: once at 8 weeks
Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)
The 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: Change from baseline to 9 weeks
Mobility measured by the Timed up & go test (TUG)
The TUG requires the participants to stand up from chair, walk at usual pace to line at 3m, turn, walk back and sit down again. The time in seconds is recorded.
Measured: Change from baseline to 9 weeks
Maximum knee/hip extension strength
Isokinetic leg press in Newton
Measured: Change from baseline to 9 weeks
Skeletal muscle mass
Bioelectrical impedance analysis (BIA)
Measured: Change from baseline to 8 weeks
Rate of persons with Albuminuria
Rate of persons with Albuminuria ≥ 2+ measured with a semi quantitative urine dipstick 24 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Rate of persons with Proteinuria
Rate of persons with Proteinuria ≥ 3+ measured with a semi quantitative urine dipstick 24 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Concentration of Urea
Concentration of Urea measured in mg/dl before, 48, 72 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Concentration of Cystatin C
Concentration of Cystatin C measured in mg/l before, 48, 72 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Concentration of Creatinine
Concentration of Creatinine measured in mg/dl before, 48, 72 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Concentration of Sodium
Concentration of Sodium measured in mmol/l before, 48, 72 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Concentration of Potassium
Concentration of Potassium measured in mmol/l before, 48, 72 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Concentration of Calcium
Concentration of Calcium measured in mmol/l before, 48, 72 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Concentration of Phosphate
Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training
Measured: measured at baseline to week 1, week 3 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start22 Jul 2020
- Primary completion31 Dec 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- frail older people (n=10) pre-post; robust older (n=10) and young (n=10) reference groups with identical intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Paracelsus Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495647
- Sponsor's protocol ID
- ETAPPEN_Pilot
- Status last verified
- Apr 2021
- First submitted
- 10 Jul 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Pilot Study
- ClinicalTrials.gov ID
- NCT04495647
- Acronym / sponsor ID
- ETAPPEN_Pilot
- Conditions
- Frailty, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Paracelsus Medical University
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 3 Aug 2020 (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 physical functioning and frailty. However, frail older people with functional impairments are among the least physically active and may have problems reaching high intensity levels. The use of special vests with integrated electrodes allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at low subjective effort level. This whole-body electromyostimulation (WB-EMS) may be a feasible option inducing training stimuli for functionally impaired frail older people.
This study aims at investigating the feasibility and safety of WB-EMS in frail older people with functional limitations. To explore the effects of age and functional status, young and robust old reference groups will serve as comparators.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- frail older people (n=10) pre-post; robust older (n=10) and young (n=10) reference groups with identical intervention
| Arm | Type | Receives |
|---|---|---|
| WB-EMS_frail | Experimental | Other: Whole-Body Electromyostimulation |
| WB-EMS_robust | Active comparator | Other: Whole-Body Electromyostimulation |
| WB-EMS_young | Active comparator | Other: Whole-Body Electromyostimulation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 75+ years
- Frail
- able to walk 4m w/o walking aid
- no prior WB-EMS exposure
- 75+ years
Key exclusion criteria (33 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 |
|---|---|---|
| Whole-Body ElectromyostimulationWhole-Body Electromyostimulation (WB-EMS): 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 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)). WB-EMS will be fully supervised one on one. All three arms will receive the same intervention. | Other | WB-EMS_frail, WB-EMS_robust, WB-EMS_young |
Primary outcome
Recruitment rate
Time frame: 8 weeks
measured by ratio of included/eligible participants
Compliance
Time frame: from baseline to 8 weeks
measured by proportion of attended training sessions
Retention rate
Time frame: at 8 weeks
measured by proportion of participants remaining in the study
Dropout rate
Time frame: from baseline to 8 weeks
measured by the proportion of participants not completing the study
Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)
Time frame: Change from baseline to 8 weeks
The PACES-8 comprises of 8 items on a 7-point bipolar rating scale. A sum score is calculated with higher PACES scores reflecting greater levels of enjoyment.
Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)
Time frame: at 8 weeks
The HRERS, reported by instructors, comprises of 5 items on a verbal rating scale from 'Never' to 'Always'. Higher scores reflect greater levels of engagement.
Concentration of Myoglobin (MB)
Time frame: measured at baseline to week 1, week 3 and week 8
Concentration of MB measured in µg/l 3 hours after training
Concentration of Creatinkinase (CK)
Time frame: measured at baseline to week 1, week 3 and week 8
Concentration of CK measured in U/l before, 48, 72 hours after training
estimated glomerular filtration rate (eGFR)
Time frame: measured at baseline to week 1, week 3 and week 8
eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training
17 secondary outcomes
Rhabdomyolysis surveillance measured by a self-developed questionnaire
Time frame: measured weekly
Pain assessed by the Brief Pain Inventory (BPI-SF)
Time frame: measured at baseline to week 1, week 3 and week 8
Fatigue assessed by the Brief Fatigue Inventory (BFI)
Time frame: measured at baseline to week 1, week 3 and week 8
System usability measured by the System Usability Scale (SUS)
Time frame: once at 8 weeks
Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)
Time frame: Change from baseline to 9 weeks
Mobility measured by the Timed up & go test (TUG)
Time frame: Change from baseline to 9 weeks
Maximum knee/hip extension strength
Time frame: Change from baseline to 9 weeks
Skeletal muscle mass
Time frame: Change from baseline to 8 weeks
Rate of persons with Albuminuria
Time frame: measured at baseline to week 1, week 3 and week 8
Rate of persons with Proteinuria
Time frame: measured at baseline to week 1, week 3 and week 8
Concentration of Urea
Time frame: measured at baseline to week 1, week 3 and week 8
Concentration of Cystatin C
Time frame: measured at baseline to week 1, week 3 and week 8
Concentration of Creatinine
Time frame: measured at baseline to week 1, week 3 and week 8
Concentration of Sodium
Time frame: measured at baseline to week 1, week 3 and week 8
Concentration of Potassium
Time frame: measured at baseline to week 1, week 3 and week 8
Concentration of Calcium
Time frame: measured at baseline to week 1, week 3 and week 8
Concentration of Phosphate
Time frame: measured at baseline to week 1, week 3 and week 8
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 28 Apr 2021.
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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 Whole-Body Electromyostimulation in people with Frailty and Mobility Limitation, 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 10 inclusion and 33 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 28 Apr 2021. 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.
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?
Recruitment rate (time frame: 8 weeks). The study lists 9 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 28 Apr 2021.