Feasibility of WB-EMS in Frail Older People

NCT04495647 | Completed

• 1 other identifier: ETAPPEN_Pilot
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Recruitment rate

  measured by ratio of included/eligible participants

  8 weeks

• Compliance

  measured by proportion of attended training sessions

  from baseline to 8 weeks

• Retention rate

  measured by proportion of participants remaining in the study

  at 8 weeks

• Dropout rate

  measured by the proportion of participants not completing the study

  from baseline to 8 weeks

• Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8)

  The PACES-8 comprises of 8 items on a 7-point bipolar rating scale. A sum score is calculated with higher PACES scores reflecting greater levels of enjoyment.

  Change from baseline to 8 weeks

• Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS)

  The HRERS, reported by instructors, comprises of 5 items on a verbal rating scale from 'Never' to 'Always'. Higher scores reflect greater levels of engagement.

  at 8 weeks

• Concentration of Myoglobin (MB)

  Concentration of MB measured in µg/l 3 hours after training

  measured at baseline to week 1, week 3 and week 8

• Concentration of Creatinkinase (CK)

  Concentration of CK measured in U/l before, 48, 72 hours after training

  measured at baseline to week 1, week 3 and week 8

• estimated glomerular filtration rate (eGFR)

  eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training

  measured at baseline to week 1, week 3 and week 8

Secondary Outcomes (17)

• Rhabdomyolysis surveillance measured by a self-developed questionnaire

  measured weekly

• Pain assessed by the Brief Pain Inventory (BPI-SF)

  measured at baseline to week 1, week 3 and week 8

• Fatigue assessed by the Brief Fatigue Inventory (BFI)

  measured at baseline to week 1, week 3 and week 8

• System usability measured by the System Usability Scale (SUS)

  once at 8 weeks

• Lower extremity functioning measured by the Short Physical Performance Battery (SPPB)

  Change from baseline to 9 weeks

Other Outcomes (11)

• Health-related quality of life measured by the patient-reported Health Survey Short Form (SF-12)

  Change from baseline to 9 weeks

• Concentration of Interleukin 6 (IL-6)

  measured at baseline to week 1, week 3 and week 8

• Concentration of High-sensitivity C-reactive protein (hs CRP)

  measured at baseline to week 1, week 3 and week 8

Study Arms (3)

WB-EMS_frail

EXPERIMENTAL

Other: Whole-Body Electromyostimulation

WB-EMS_robust

ACTIVE COMPARATOR

Other: Whole-Body Electromyostimulation

WB-EMS_young

ACTIVE COMPARATOR

Other: Whole-Body Electromyostimulation

Interventions

Whole-Body Electromyostimulation 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_frail; WB-EMS_robust; WB-EMS_young

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• + years
• Frail
• able to walk 4m w/o walking aid
• 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
• Robust people
• + years
• Robust
• no prior WB-EMS exposure
• severe visual or hearing impairments

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Paracelsus Medical University: collaborator

Study Sites (1)

Institute of Medical Physics, University of Erlangen-Nürnberg

Erlangen, 91052, Germany

Location

MeSH Terms

Conditions

Frailty; Mobility Limitation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: frail older people (n=10) pre-post; robust older (n=10) and young (n=10) reference groups with identical intervention

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: August 3, 2020
• Study Start: July 22, 2020
• Primary Completion: December 31, 2020
• Study Completion: February 28, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

DE (1)