Efficacy of WB-EMS in Frail Older People
- Conditions
- Frailty Syndrome
- Interventions
- Behavioral: social contact control groupBehavioral: WB-EMS
- Registration Number
- NCT04967534
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- aged 65 years and older
- frail according to Tilburg Frailty Indicator
- residing in assisted living facility or nursing home
- able to walk 4m w/o walking aid but without personal assistance
- 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
- Ventricular arrhythmias requiring therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description social contact control group social contact control group - WB-EMS WB-EMS -
- Primary Outcome Measures
Name Time Method Change in Lower Extremity Functioning 8 weeks, 16 weeks, 32 weeks 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).
- Secondary Outcome Measures
Name Time Method Change in leg strength 8 weeks, 16 weeks, 32 weeks Maximal isometric knee extension strength will be assessed on the dominant leg with the participant seated. Three trials will be conducted.
Change in maximal hand grip strength 8 weeks, 16 weeks, 32 weeks Grip strength will be assessed on the dominant hand using a digital dynamometer with the participant seated. Three trials will be conducted.
Change in concentration of total cholesterol 16 weeks Concentration of Cholesterin measured in mg/dl before first and last trainings
Change in concentration of low-density lipoprotein (LDL) 16 weeks Concentration of LDL measured in mg/dl before first and last trainings
Change in concentration of glucose 16 weeks Concentration of Glucose measured in mg/dl before first and last trainings
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 8 weeks, 16 weeks 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.
Change in Mobility measured by the Timed up & go test (TUG) 8 weeks, 16 weeks, 32 weeks 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.
Change in gait speed 16 weeks, 32 weeks 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
Change in lean mass 16 weeks, 32 weeks Lean mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Change in fat mass 16 weeks, 32 weeks Fat mass will be assessed using Bioelectrical Impedance Analysis (BIA).
Change in Choice Stepping Reaction Time (CSRT) test 16 weeks, 32 weeks 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.
Change in Body Sway 8 weeks, 16 weeks, 32 weeks An instrumented test of postural sway (ISway) using a body-worn accelerometer will be used.
Change in Balance performance 16 weeks, 32 weeks 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.
Change in Frailty Status 16 weeks, 32 weeks 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.Change in Physical Activity 16 weeks 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.
Change in concentration of Triglycerides 16 weeks Concentration of Triglycerides measured in mg/dl before first and last trainings
Change in concentration of high-density lipoprotein (HDL) 16 weeks Concentration of HDL measured in mg/dl before first and last trainings
Change in concentration of Creatinkinase (CK) 8 weeks, 16 weeks Concentration of CK measured in U/l before the first and after the last training
Change in Quality of Life (QoL) 16 weeks 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.
Change in Functional Balance 16 weeks, 32 weeks 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
Change in concentration of Creatinine 8 weeks, 16 weeks Concentration of Creatinine measured in mg/dl before the first and after the last training
Change in estimated glomerular filtration rate (eGFR) 8 weeks, 16 weeks eGFR (creatinine clearance) measured in mL/min/1.73m² before the first and after the last training
Change in continence status 16 weeks, 32 weeks 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).
Change in depressive symptoms 16 weeks, 32 weeks 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.
Change in concerns about falling 16 weeks, 32 weeks 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.
Change in sarcopenia specific QoL 16 weeks, 32 weeks 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.
Change in Health-related Quality of Life (HrQoL) 8 weeks, 16 weeks, 32 weeks 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.
Trial Locations
- Locations (1)
Institute of Medical Physics, University of Erlangen-Nürnberg
🇩🇪Erlangen, Bavaria, Germany