Feasibility of WB-EMS in Frail Older People

NCT ID: NCT04495647

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-22
• Study Completion Date: 2021-02-28

Brief Summary

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.

Conditions

Frailty; Mobility Limitation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WB-EMS_frail

Group Type: EXPERIMENTAL

Whole-Body Electromyostimulation

Intervention Type: OTHER

Whole-Body Electromyostimulation (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 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)).

WB-EMS will be fully supervised one on one.

All three arms will receive the same intervention.

WB-EMS_robust

Group Type: ACTIVE_COMPARATOR

Whole-Body Electromyostimulation

Intervention Type: OTHER

Whole-Body Electromyostimulation (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 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)).

WB-EMS will be fully supervised one on one.

All three arms will receive the same intervention.

WB-EMS_young

Group Type: ACTIVE_COMPARATOR

Whole-Body Electromyostimulation

Intervention Type: OTHER

Whole-Body Electromyostimulation (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 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)).

WB-EMS will be fully supervised one on one.

All three arms will receive the same intervention.

Interventions

Whole-Body Electromyostimulation

Whole-Body Electromyostimulation (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 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)).

WB-EMS will be fully supervised one on one.

All three arms will receive the same intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 75+ years
• Frail
• able to walk 4m w/o walking aid
• no prior WB-EMS exposure

• 75+ years
• Robust
• no prior WB-EMS exposure

• 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

Robust people

• 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

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Paracelsus Medical University

OTHER

Sponsor Role: collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Medical Physics, University of Erlangen-Nürnberg

Erlangen, , Germany

Countries

Germany

Other Identifiers

ETAPPEN_Pilot

Identifier Type: -

Identifier Source: org_study_id