Feasibility of WB-EMS in Frail Older People
- Conditions
- FrailtyMobility Limitation
- Interventions
- Other: Whole-Body Electromyostimulation
- Registration Number
- NCT04495647
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 75+ years
- Frail
- able to walk 4m w/o walking aid
- no prior WB-EMS exposure
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WB-EMS_robust Whole-Body Electromyostimulation - WB-EMS_frail Whole-Body Electromyostimulation - WB-EMS_young Whole-Body Electromyostimulation -
- Primary Outcome Measures
Name Time Method estimated glomerular filtration rate (eGFR) 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
Recruitment rate 8 weeks measured by ratio of included/eligible participants
Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8) 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.
Concentration of Myoglobin (MB) measured at baseline to week 1, week 3 and week 8 Concentration of MB measured in µg/l 3 hours after training
Compliance from baseline to 8 weeks measured by proportion of attended training sessions
Retention rate at 8 weeks measured by proportion of participants remaining in the study
Dropout rate from baseline to 8 weeks measured by the proportion of participants not completing the study
Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS) 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 Creatinkinase (CK) measured at baseline to week 1, week 3 and week 8 Concentration of CK measured in U/l before, 48, 72 hours after training
- Secondary Outcome Measures
Name Time Method Pain assessed by the Brief Pain Inventory (BPI-SF) 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.
Fatigue assessed by the Brief Fatigue Inventory (BFI) 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.
Rhabdomyolysis surveillance measured by a self-developed questionnaire 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)
System usability measured by the System Usability Scale (SUS) 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.
Lower extremity functioning measured by the Short Physical Performance Battery (SPPB) 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).
Mobility measured by the Timed up & go test (TUG) 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.
Maximum knee/hip extension strength Change from baseline to 9 weeks Isokinetic leg press in Newton
Skeletal muscle mass Change from baseline to 8 weeks Bioelectrical impedance analysis (BIA)
Concentration of Urea measured at baseline to week 1, week 3 and week 8 Concentration of Urea measured in mg/dl before, 48, 72 hours after training
Rate of persons with Albuminuria 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
Rate of persons with Proteinuria 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
Concentration of Sodium measured at baseline to week 1, week 3 and week 8 Concentration of Sodium measured in mmol/l before, 48, 72 hours after training
Concentration of Cystatin C 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
Concentration of Creatinine measured at baseline to week 1, week 3 and week 8 Concentration of Creatinine measured in mg/dl before, 48, 72 hours after training
Concentration of Potassium measured at baseline to week 1, week 3 and week 8 Concentration of Potassium measured in mmol/l before, 48, 72 hours after training
Concentration of Calcium measured at baseline to week 1, week 3 and week 8 Concentration of Calcium measured in mmol/l before, 48, 72 hours after training
Concentration of Phosphate measured at baseline to week 1, week 3 and week 8 Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training
Trial Locations
- Locations (1)
Institute of Medical Physics, University of Erlangen-Nürnberg
🇩🇪Erlangen, Germany