Feasibility of WB-EMS in Frail Older People

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Frailty; Mobility Limitation

Treatments: Other: Whole-Body Electromyostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04495647

ETAPPEN_Pilot

Details and patient eligibility

About

Exercise in general and resistance training (RT) in particular have demonstrated positive effects on physical functioning and frailty. However, frail older people with functional impairments are among the least physically active and may have problems reaching high intensity levels. The use of special vests with integrated electrodes allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at low subjective effort level. This whole-body electromyostimulation (WB-EMS) may be a feasible option inducing training stimuli for functionally impaired frail older people.

This study aims at investigating the feasibility and safety of WB-EMS in frail older people with functional limitations. To explore the effects of age and functional status, young and robust old reference groups will serve as comparators.

Enrollment: 30 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Frail people

Inclusion Criteria:

• 75+ years
• Frail
• able to walk 4m w/o walking aid
• 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

Robust people

Inclusion Criteria:

• 75+ years
• Robust
• 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

Younger people

Inclusion Criteria:

• 18-50 years
• Healthy
• 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
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

WB-EMS_frail

Experimental group

Treatment:

Other: Whole-Body Electromyostimulation

WB-EMS_robust

Active Comparator group

Treatment:

Other: Whole-Body Electromyostimulation

WB-EMS_young

Active Comparator group

Treatment:

Other: Whole-Body Electromyostimulation