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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Institute of Medical Physics, University of Erlangen-Nürnberg
Erlangen, Germany
Recruitment rate
measured by ratio of included/eligible participants
Time frame: 8 weeks
Compliance
measured by proportion of attended training sessions
Time frame: from baseline to 8 weeks
Retention rate
measured by proportion of participants remaining in the study
Time frame: at 8 weeks
Dropout rate
measured by the proportion of participants not completing the study
Time frame: 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.
Time frame: 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.
Time frame: at 8 weeks
Concentration of Myoglobin (MB)
Concentration of MB measured in µg/l 3 hours after training
Time frame: 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
Time frame: 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
Time frame: measured at baseline to week 1, week 3 and week 8
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Change from baseline to 9 weeks
Maximum knee/hip extension strength
Isokinetic leg press in Newton
Time frame: Change from baseline to 9 weeks
Skeletal muscle mass
Bioelectrical impedance analysis (BIA)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: measured at baseline to week 1, week 3 and week 8