Clinical trial NCT04967534: Efficacy of WB-EMS in Frail Older People
Official title: The Efficacy of Whole-Body Electromyostimulation (WB-EMS) in Frail Older People: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty Syndrome
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group (1:1) randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Lower Extremity Functioning
timeFrame: 8 weeks, 16 weeks, 32 weeks
Secondary outcomes:
measure: Change in Mobility measured by the Timed up & go test (TUG)
timeFrame: 8 weeks, 16 weeks, 32 weeks
measure: Change in leg strength
timeFrame: 8 weeks, 16 weeks, 32 weeks
measure: Change in maximal hand grip strength
timeFrame: 8 weeks, 16 weeks, 32 weeks
measure: Change in gait speed
timeFrame: 16 weeks, 32 weeks
measure: Change in Choice Stepping Reaction Time (CSRT) test
timeFrame: 16 weeks, 32 weeks
measure: Change in Body Sway
timeFrame: 8 weeks, 16 weeks, 32 weeks
measure: Change in Balance performance
timeFrame: 16 weeks, 32 weeks
measure: Change in Functional Balance
timeFrame: 16 weeks, 32 weeks
measure: Change in Frailty Status
timeFrame: 16 weeks, 32 weeks
measure: Change in lean mass
timeFrame: 16 weeks, 32 weeks
measure: Change in fat mass
timeFrame: 16 weeks, 32 weeks
measure: Change in Physical Activity
timeFrame: 16 weeks
measure: Change in concentration of Triglycerides
timeFrame: 16 weeks
measure: Change in concentration of total cholesterol
timeFrame: 16 weeks
measure: Change in concentration of high-density lipoprotein (HDL)
timeFrame: 16 weeks
measure: Change in concentration of low-density lipoprotein (LDL)
timeFrame: 16 weeks
measure: Change in concentration of glucose
timeFrame: 16 weeks
measure: Change in concentration of Creatinkinase (CK)
timeFrame: 8 weeks, 16 weeks
measure: Change in concentration of Creatinine
timeFrame: 8 weeks, 16 weeks
measure: Change in estimated glomerular filtration rate (eGFR)
timeFrame: 8 weeks, 16 weeks
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 8 weeks, 16 weeks
measure: Change in continence status
timeFrame: 16 weeks, 32 weeks
measure: Change in depressive symptoms
timeFrame: 16 weeks, 32 weeks
measure: Change in concerns about falling
timeFrame: 16 weeks, 32 weeks
measure: Change in Quality of Life (QoL)
timeFrame: 16 weeks
measure: Change in sarcopenia specific QoL
timeFrame: 16 weeks, 32 weeks
measure: Change in Health-related Quality of Life (HrQoL)
timeFrame: 8 weeks, 16 weeks, 32 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics, University of Erlangen-Nürnberg
state: Bavaria
Study officials:
affiliation: University of Erlangen-Nürnberg Medical School
name: Wolfgang Kemmler, PhD
role: PRINCIPAL_INVESTIGATOR
References: