Efficacy of WB-EMS in Frail Older People

NCT04967534 | Completed

• 1 other identifier: ETAPPEN_MAIN
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Change in Mobility measured by the Timed up & go test (TUG)

  8 weeks, 16 weeks, 32 weeks

• Change in leg strength

  8 weeks, 16 weeks, 32 weeks

• Change in maximal hand grip strength

  8 weeks, 16 weeks, 32 weeks

• Change in gait speed

  16 weeks, 32 weeks

• Change in Choice Stepping Reaction Time (CSRT) test

  16 weeks, 32 weeks

Study Arms (2)

WB-EMS

EXPERIMENTAL

Behavioral: WB-EMS

social contact control group

SHAM COMPARATOR

Behavioral: social contact control group

Interventions

WB-EMS BEHAVIORAL

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.

WB-EMS

social contact control group BEHAVIORAL

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.

social contact control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Institute of Medical Physics, University of Erlangen-Nürnberg

Erlangen, Bavaria, 91052, Germany

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolfgang Kemmler, PhD

  University of Erlangen-Nürnberg Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel-group (1:1) randomized controlled trial

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 19, 2021
• Study Start: July 21, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: July 21, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to wolfgang.kemmler@imp.uni-erlangen.de

Locations

DE (1)