Feasibility of WB-EMS in Frail Older People

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Safety of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Pilot Study

Conditions
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Frailty, Mobility Limitation

Intervention / Treatment
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* Other: Whole-Body Electromyostimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WB-EMS_frail<br> | Other: Whole-Body Electromyostimulation<br>* 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.<br>|
| Active Comparator: WB-EMS_robust<br> | Other: Whole-Body Electromyostimulation<br>* 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.<br>|
| Active Comparator: WB-EMS_young<br> | Other: Whole-Body Electromyostimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | measured by ratio of included/eligible participants | 8 weeks | 
| Compliance | measured by proportion of attended training sessions | from baseline to 8 weeks | 
| Retention rate | measured by proportion of participants remaining in the study | at 8 weeks | 
| Dropout rate | 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) | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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) | 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 | Isokinetic leg press in Newton | Change from baseline to 9 weeks | 
| Skeletal muscle mass | Bioelectrical impedance analysis (BIA) | 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 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 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 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 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 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 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 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 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 at baseline to week 1, week 3 and week 8 |