Efficacy of WB-EMS in Frail Older People

Frailty Syndrome Clinical Trial

Official title:

The Efficacy of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967534
• Other study ID #: ETAPPEN_MAIN
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: July 2021
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

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

• Ventricular arrhythmias requiring therapy

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome

Intervention

Behavioral:
• 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 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.
• social contact control group
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.

Locations

Country	Name	City	State
Germany	Institute of Medical Physics, University of Erlangen-Nürnberg	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	8 weeks, 16 weeks, 32 weeks
Secondary	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.	8 weeks, 16 weeks, 32 weeks
Secondary	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.	8 weeks, 16 weeks, 32 weeks
Secondary	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.	8 weeks, 16 weeks, 32 weeks
Secondary	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	16 weeks, 32 weeks
Secondary	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.	16 weeks, 32 weeks
Secondary	Change in Body Sway	An instrumented test of postural sway (ISway) using a body-worn accelerometer will be used.	8 weeks, 16 weeks, 32 weeks
Secondary	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.	16 weeks, 32 weeks
Secondary	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	16 weeks, 32 weeks
Secondary	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.	16 weeks, 32 weeks
Secondary	Change in lean mass	Lean mass will be assessed using Bioelectrical Impedance Analysis (BIA).	16 weeks, 32 weeks
Secondary	Change in fat mass	Fat mass will be assessed using Bioelectrical Impedance Analysis (BIA).	16 weeks, 32 weeks
Secondary	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.	16 weeks
Secondary	Change in concentration of Triglycerides	Concentration of Triglycerides measured in mg/dl before first and last trainings	16 weeks
Secondary	Change in concentration of total cholesterol	Concentration of Cholesterin measured in mg/dl before first and last trainings	16 weeks
Secondary	Change in concentration of high-density lipoprotein (HDL)	Concentration of HDL measured in mg/dl before first and last trainings	16 weeks
Secondary	Change in concentration of low-density lipoprotein (LDL)	Concentration of LDL measured in mg/dl before first and last trainings	16 weeks
Secondary	Change in concentration of glucose	Concentration of Glucose measured in mg/dl before first and last trainings	16 weeks
Secondary	Change in concentration of Creatinkinase (CK)	Concentration of CK measured in U/l before the first and after the last training	8 weeks, 16 weeks
Secondary	Change in concentration of Creatinine	Concentration of Creatinine measured in mg/dl before the first and after the last training	8 weeks, 16 weeks
Secondary	Change in estimated glomerular filtration rate (eGFR)	eGFR (creatinine clearance) measured in mL/min/1.73m² before the first and after the last training	8 weeks, 16 weeks
Secondary	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.	8 weeks, 16 weeks
Secondary	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).	16 weeks, 32 weeks
Secondary	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.	16 weeks, 32 weeks
Secondary	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.	16 weeks, 32 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks, 32 weeks
Secondary	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.	8 weeks, 16 weeks, 32 weeks