- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495647
Feasibility of WB-EMS in Frail Older People
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erlangen, Germany, 91052
- Institute of Medical Physics, University of Erlangen-Nurnberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Frail people
Inclusion Criteria:
- 75+ years
- Frail
- able to walk 4m w/o walking aid
- no prior WB-EMS exposure
Exclusion Criteria:
- 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
Robust people
Inclusion Criteria:
- 75+ years
- Robust
- no prior WB-EMS exposure
Exclusion Criteria:
- 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
Inclusion Criteria:
- 18-50 years
- Healthy
- no prior WB-EMS exposure
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WB-EMS_frail
|
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. |
Active Comparator: WB-EMS_robust
|
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. |
Active Comparator: WB-EMS_young
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate
Time Frame: 8 weeks
|
measured by ratio of included/eligible participants
|
8 weeks
|
Compliance
Time Frame: from baseline to 8 weeks
|
measured by proportion of attended training sessions
|
from baseline to 8 weeks
|
Retention rate
Time Frame: at 8 weeks
|
measured by proportion of participants remaining in the study
|
at 8 weeks
|
Dropout rate
Time Frame: from baseline to 8 weeks
|
measured by the proportion of participants not completing the study
|
from baseline to 8 weeks
|
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.
|
Change from baseline to 8 weeks
|
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.
|
at 8 weeks
|
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
|
measured at baseline to week 1, week 3 and week 8
|
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
|
measured at baseline to week 1, week 3 and week 8
|
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
|
measured at baseline to week 1, week 3 and week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rhabdomyolysis surveillance measured by a self-developed questionnaire
Time Frame: measured weekly
|
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 weekly
|
Pain assessed by the Brief Pain Inventory (BPI-SF)
Time Frame: measured at baseline to week 1, week 3 and week 8
|
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 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
|
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 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
|
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.
|
once at 8 weeks
|
Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)
Time Frame: Change from baseline to 9 weeks
|
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).
|
Change from baseline to 9 weeks
|
Mobility measured by the Timed up & go test (TUG)
Time Frame: Change from baseline to 9 weeks
|
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.
|
Change from baseline to 9 weeks
|
Maximum knee/hip extension strength
Time Frame: Change from baseline to 9 weeks
|
Isokinetic leg press in Newton
|
Change from baseline to 9 weeks
|
Skeletal muscle mass
Time Frame: Change from baseline to 8 weeks
|
Bioelectrical impedance analysis (BIA)
|
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 Albuminuria ≥ 2+ measured with a semi quantitative urine dipstick 24 hours after training
|
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
|
Rate of persons with Proteinuria ≥ 3+ measured with a semi quantitative urine dipstick 24 hours after training
|
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 Urea measured in mg/dl before, 48, 72 hours after training
|
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 Cystatin C measured in mg/l before, 48, 72 hours after training
|
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 Creatinine measured in mg/dl before, 48, 72 hours after training
|
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 Sodium measured in mmol/l before, 48, 72 hours after training
|
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 Potassium measured in mmol/l before, 48, 72 hours after training
|
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 Calcium measured in mmol/l before, 48, 72 hours after training
|
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
|
Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training
|
measured at baseline to week 1, week 3 and week 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related quality of life measured by the patient-reported Health Survey Short Form (SF-12)
Time Frame: Change from baseline to 9 weeks
|
The SF-12 comprises of 12 items weighted and summed to provide physical and mental health scores (PCS and MCS), ranging from 0 to 100 with higher scores reflecting greater levels of the respective construct.
|
Change from baseline to 9 weeks
|
Concentration of Interleukin 6 (IL-6)
Time Frame: measured at baseline to week 1, week 3 and week 8
|
Concentration of IL-6 measured in ng/l before, 3h, 48, 72 hours after training
|
measured at baseline to week 1, week 3 and week 8
|
Concentration of High-sensitivity C-reactive protein (hs CRP)
Time Frame: measured at baseline to week 1, week 3 and week 8
|
Concentration of hs CRP measured in mg/l before, 48, 72 hours after training
|
measured at baseline to week 1, week 3 and week 8
|
Concentration of Cholesterin
Time Frame: measured at baseline and week 8
|
Concentration of Cholesterin measured in mg/dl before first and last trainings
|
measured at baseline and week 8
|
Concentration of low-density lipoprotein (LDL)
Time Frame: measured at baseline and week 8
|
Concentration of LDL measured in mg/dl before first and last trainings
|
measured at baseline and week 8
|
Concentration of high-density lipoprotein (HDL)
Time Frame: measured at baseline and week 8
|
Concentration of HDL measured in mg/dl before first and last trainings
|
measured at baseline and week 8
|
Concentration of Triglycerides
Time Frame: measured at baseline and week 8
|
Concentration of Triglycerides measured in mg/dl before first and last trainings
|
measured at baseline and week 8
|
Concentration of N-terminal pro b-type natriuretic peptide (NT-proBNP)
Time Frame: measured at baseline to week 1, week 3 and week 8
|
Concentration of NT-proBNP measured in pg/ml before, 48, 72 hours after training
|
measured at baseline to week 1, week 3 and week 8
|
Concentration of Glucose
Time Frame: measured at baseline and week 8
|
Concentration of Glucose measured in mg/dl before first and last trainings
|
measured at baseline and week 8
|
Concentration of Creatinkinase Muscle/Brain (CK-MB (CK-2))
Time Frame: measured at baseline to week 1, week 3 and week 8
|
Concentration of CK-MB (CK-2) measured in ng/ml before, 48, 72 hours after training
|
measured at baseline to week 1, week 3 and week 8
|
Concentration of high-sensitive cardiac troponin T (hs-cTnT)
Time Frame: measured at baseline to week 1, week 3 and week 8
|
Concentration of hs-cTnT measured in ng/ml before, 48, 72 hours after training
|
measured at baseline to week 1, week 3 and week 8
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETAPPEN_Pilot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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