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Efficacy of WB-EMS in Frail Older People

U

University of Erlangen-Nürnberg Medical School

Status

Completed

Conditions

Frailty Syndrome

Treatments

Behavioral: social contact control group
Behavioral: WB-EMS

Study type

Interventional

Funder types

Other

Identifiers

NCT04967534
ETAPPEN_MAIN

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 2 patient groups

WB-EMS
Experimental group
Treatment:
Behavioral: WB-EMS
social contact control group
Sham Comparator group
Treatment:
Behavioral: social contact control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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