Exercise in general and resistance training (RT) in particular have demonstrated positive effects on frailty outcomes, including physical functioning. However, frail older people with functional impairments are among the least physically active and have problems reaching high-intensity levels. Whole-body electromyostimulation (WB-EMS) allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at a low subjective effort level. The efficacy of WB-EMS in frail older people has yet to be determined. The primary objective of this study is to investigate the efficacy of WB-EMS in frail older people.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
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 12 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping, and lower extremity strength will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by the rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)). WB-EMS will be fully supervised one-on-one.
Psycho-social intervention with participants randomized to the control group receiving (if wanted) the same social contact time (20-30 minutes/week) as the WB-EMS group. Depending on personal preferences and Covid-19 restrictions this will be done by phone or in-person one-on-one. Health-related topics and/or general chatting will be offered.
Institute of Medical Physics, University of Erlangen-Nürnberg
Erlangen, Bavaria, Germany
Change in Lower Extremity Functioning
The Short Physical Performance Battery (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: 8 weeks, 16 weeks, 32 weeks
Change in Mobility measured by the Timed up & go test (TUG)
The TUG requires the participants to stand up from a chair, walk at usual pace to line at 3m, turn, walk back and sit down again. The time in seconds is recorded.
Time frame: 8 weeks, 16 weeks, 32 weeks
Change in leg strength
Maximal isometric knee extension strength will be assessed on the dominant leg with the participant seated. Three trials will be conducted.
Time frame: 8 weeks, 16 weeks, 32 weeks
Change in maximal hand grip strength
Grip strength will be assessed on the dominant hand using a digital dynamometer with the participant seated. Three trials will be conducted.
Time frame: 8 weeks, 16 weeks, 32 weeks
Change in gait speed
Gait speed will be assessed over 6 meters under 3 conditions, 1) walking at usual pace, 2) walking at usual pace while counting backwards by 3, 3) walking at fast pace
Time frame: 16 weeks, 32 weeks
Change in Choice Stepping Reaction Time (CSRT) test
CSRT time will be measured as the total time to complete 12 steps onto four targets printed on a portable rubber mat following 8 practice trials.
Time frame: 16 weeks, 32 weeks
Change in Body Sway
An instrumented test of postural sway (ISway) using a body-worn accelerometer will be used.
Time frame: 8 weeks, 16 weeks, 32 weeks
Change in Balance performance
The Berg Balance Scale (BBS) will be used to assess 14 balance tasks of static and dynamic stability. Each task is scored on a five-point scale according to quality or time ranging from "0" (lowest level of function) to "4" (highest level). The maximum score is 56.
Time frame: 16 weeks, 32 weeks
Change in Functional Balance
The Alternate Step Test (AST) measures the time required to place the feet eight times in alternate order on a sturdy step (18 cm high) as fast as possible
Time frame: 16 weeks, 32 weeks
Change in Frailty Status
Frailty will be assessed by the Fried Phenotype and the Tilburg Frailty Indicator (TFI). The Fried phenotype comprises of muscle weakness, fatigue, slowness, low physical activity levels, unintentional weight loss, each scored as 0 (criterion not fulfilled) or 1 (criterion fulfilled). A total sum score of 0 indicates a person is robust, a score of 1 or 2 indicates pre-frailty and a score of 3-5 indicates frailty. The TFI is a self-reported frailty scale consisting of 3 domains, physical (8 items), psychological (4 items) and social (3 items). A total sum score greater or equal to 5 indicates frailty.
Time frame: 16 weeks, 32 weeks
Change in lean mass
Lean mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Time frame: 16 weeks, 32 weeks
Change in fat mass
Fat mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Time frame: 16 weeks, 32 weeks
Change in Physical Activity
Physical activities will be assessed using a 7-day accelerometry measurement. The device (ActivPAL 3 micro) will be attached to participants' thigh and worn over the complete 7-day/24-hour period.
Time frame: 16 weeks
Change in concentration of Triglycerides
Concentration of Triglycerides measured in mg/dl before first and last trainings
Time frame: 16 weeks
Change in concentration of total cholesterol
Concentration of Cholesterin measured in mg/dl before first and last trainings
Time frame: 16 weeks
Change in concentration of high-density lipoprotein (HDL)
Concentration of HDL measured in mg/dl before first and last trainings
Time frame: 16 weeks
Change in concentration of low-density lipoprotein (LDL)
Concentration of LDL measured in mg/dl before first and last trainings
Time frame: 16 weeks
Change in concentration of glucose
Concentration of Glucose measured in mg/dl before first and last trainings
Time frame: 16 weeks
Change in concentration of Creatinkinase (CK)
Concentration of CK measured in U/l before the first and after the last training
Time frame: 8 weeks, 16 weeks
Change in concentration of Creatinine
Concentration of Creatinine measured in mg/dl before the first and after the last training
Time frame: 8 weeks, 16 weeks
Change in estimated glomerular filtration rate (eGFR)
eGFR (creatinine clearance) measured in mL/min/1.73m² before the first and after the last training
Time frame: 8 weeks, 16 weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Pain and function due to orthopedic problems will be assessed with the WOMAC questionnaire, comprising of 24 items each scored on a 5-point Likert scale.
Time frame: 8 weeks, 16 weeks
Change in continence status
Continence status (frequency, severity, perceived burden, timing) will be assessed using the International Consultation on Incontinence Questionnaire (ICIQ, 5 items) and the short form of the Urogenital Distress Inventory (UDI-6, 6 items).
Time frame: 16 weeks, 32 weeks
Change in depressive symptoms
Depressive symptoms will be assessed using the Iowa version of the Center for Epidemiologic Studies Depression Scale (CES-D), consisting of 11 items, each scored on a 3-point rating scale. The total sum score is calculated.
Time frame: 16 weeks, 32 weeks
Change in concerns about falling
The Falls-efficacy Scale-International (FES-I) questionnaire will be used to assess the concerns about falling during 16 activities of daily living. Each item is scored on a 4-point rating scale and the total sum score is calculated.
Time frame: 16 weeks, 32 weeks
Change in Quality of Life (QoL)
QoL will be assessed with 26-item WHOQOL-BREF covering physical health, psychological health, social relationships and environmental aspects. Each item is scored on a 5-point Likert scale.
Time frame: 16 weeks
Change in sarcopenia specific QoL
Sarcopenia specific QoL will be assessed with the SarQoL, comprising of 55 items in 22 questions rated on a 4-point Likert scale. Seven domains are specified: Physical and mental health, Locomotion, Body composition, Functionality, Activities of daily living, Leisure activities and Fear.
Time frame: 16 weeks, 32 weeks
Change in Health-related Quality of Life (HrQoL)
HrQoL will be assessed using the 4-item HowRu scale comprising of 4 variables: pain or discomfort, feeling low or worried, limitation in activities and dependency on others. Each item is scored on a 4-point visual analogue scale.
Time frame: 8 weeks, 16 weeks, 32 weeks
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